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 Table of Contents  
Year : 2023  |  Volume : 2  |  Issue : 3  |  Page : 9-29

Clinical Sciences

Date of Web Publication10-Mar-2023

Correspondence Address:
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2773-1316.371187

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How to cite this article:
. Clinical Sciences. Chron Diabetes Res Pract 2023;2, Suppl S1:9-29

How to cite this URL:
. Clinical Sciences. Chron Diabetes Res Pract [serial online] 2023 [cited 2023 Mar 30];2, Suppl S1:9-29. Available from: https://cdrpj.org//text.asp?2023/2/3/9/371187

  1. Personal Hygiene and SGLT2i Top

Abhisekh Raha

Lumding Divisional Railway Hospital, Assam, India

E-mail: [email protected]

Introduction: Role of personal hygiene in preventing perineal infection arising out of SGLT2i usage has not been well studied. We aimed to study the effect of washing perineal area with water only after every act of micturition in preventing genital infection arising out of SGLT2i usage.

Methods: Thirty Type 2 diabetic mellitus (T2DM) patients of age group 40–55 years who are uncontrolled on metformin and glimepiride of various strengths and dosage schedules are divided into 2 groups of 15, and the two groups are named intervention and control groups. Both the groups were given dapagliflozin 10 mg for the first time. The intervention group was taught about maintenance of personal hygiene and counseled for strict maintenance, while the control group was not counseled for personal hygiene maintenance. Both the groups were followed up weekly for a period of 4 months to detect any perineal infection following SGLT2i usage.

Results: No perineal infection was noted in the intervention group. However, in the control group, perineal infection was noted in all of the 15 patients and most of them were fungal infections. Eleven of them had a fungal infection of the genital area and 4 of them had a mild urinary tract infection, cured with oral medication on an OPD basis.

Conclusion: T2DM patients on dapagliflozin (SGLT2i) can prevent perineal infection with the proper maintenance of personal hygiene.

  2. Premeal Almond Intake and its Effect on Postprandial Blood Sugar Top

Abhisekh Raha

Lumding Divisional Railway Hospital, Lumding, Assam, India

E-mail: [email protected]

Introduction: Use of almonds as a snack in patients with diabetes led to improved HbA1c, however effect of premeal almond intake on postprandial blood glucose levels has not been well studied.

Methods: Eighty type 2 diabetes mellitus (T2DM) patients of age group 40–55 years comprising both males and females, who are uncontrolled on metformin 1000 mg BD and glimepiride 2 mg BD, are divided into two groups of 40, and the two groups are named intervention and control groups. The intervention group was asked to take 20 g of almond 30 min before lunch and dinner and counseled for strict maintenance while the control group was not asked to take almonds. There was no additional exercise regimen for either group.

Both the groups were followed for 4 months and their postprandial blood sugar (PPBS) was measured every week.

Results: It was found that the intervention group had an average PPBS fall of 46 mg/dl.

Conclusion: T2DM patients who consume 20 g of almond 30 min before lunch and dinner can have a better glycemic control (PPBS).

  3. Critical Analysis of Clinical Outcomes in Diabetic Foot Osteomyelitis Treated with Various Treatment Modalities Top

Amit R. Burande*, Meeta A. Burande, Tanmay U. Vora, Pallavi T. Vora, Prakash G. Sharbidre, Vijay D. Kassa

*Surya Hospital, Kolhapur, Maharashtra, India

E-mail: [email protected]

Introduction: Diabetic foot osteomyelitis (DFOM) may result in minor and major amputation as well as death. We aimed to analyze the treatment outcome in DFOM in terms of limb salvage.

Methods: A descriptive clinical analysis of retrospective cohort of patients having DFOM.

All patients having diabetes and foot infection and osteomyelitis of foot confirmed by probe to bone test and/or imaging modalities.

Bone deep surgical debridement in all patients; additional following procedures – FHL excision/first metatarsal head excision/excision arthroplasty of MTP/implants – K-wire, external fixator, ilizarov/antibiotic-coated bone cement beads/others – sequestrectomy, periosteal stripping, partial excision of distal phalanx, ray amputation, great toe amputation, and partial calcanectomy; and traditional dressings and local oxygen/VAC/skin grafting/flap suture.

Results: Altogether thirty patients 23 m/7 f, age 52.28 ± 9.75 years were enrolled. The mean duration of diabetes was 12.81 ± 5.62 years and mean duration of wound was 31.9 ± 50.50 days, X-ray was normal in 42% of foots. Forefoot osteomyelitis was seen in 87.09% (67.4% great toe [first ray], 19.35% lateral rays, 3.22% mid-foot, 9.67% heel, 3.22% lower leg). The mean wound area was 9.94 ± 9.07 cm2.

(1) Great toe or first ray – OVER-ALL 84.21% toes were saved. Plantar wound - 92.3% have FHL infection and FHL excised in 84.61% and 72.72% SAVED. Medial and Lateral wounds-antibiotic-coated cement, fixator or k wire– 100% SAVED. Lateral 4 rays - OVER-ALL 16.6% toes were saved.

Conclusion: Great toe osteomyelitis is the most prevalent presentation, accounting for 68% of cases. Approach to treatment involves combined modalities with average duration of wound healing was 40.67 ± 28.51 days. The primary outcome of first-ray salvage was achieved in 84.21%, lateral four-ray salvage in 16.6%, and limb salvage in 100% of cases.

  4. Novel Medical Laser Shoe Photobiomodulation on Neuropathic Pain and Plantar Pressure Profile in Type 2 Diabetes Mellitus with Peripheral Neuropathy Top

G. Arun Maiya*, K. Hrishikesh Yadav, H. Manjunath Hande, Radhika Jadhav

*Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India

E-mail: [email protected]

Introduction: Photobiomodulation or low-level laser is used to treat diabetic foot complications. The existing method of laser application to the foot was not covering the foot's entire area to improve the foot's microcirculation. Therefore, we have developed a cost-effective special laser shoe device, focusing exclusively on the entire foot region to manage neuropathic pain and other symptoms in individuals with type 2 diabetes mellitus. The main objective of the present study was to find out the effect of this newly developed special laser shoe photobiomodulation on neuropathic pain and plantar pressure profile in individuals with type 2 diabetes mellitus with neuropathy.

Methods: We included 60 participants of type 2 diabetes of both the genders of age more than 20 years. Participants were treated with photobiomodulation by a specially designed novel laser shoe. Outcomes were clinical variables such as vibration perception threshold (VPT), visual analog scale (VAS), Michigan Neuropathy Screening Instrument A&B, ankle-brachial index (ABI), and static dynamic gait parameters.

Results: Participants were with an average age of 62, and the average duration of diabetes was 11 years. Analysis showed a significant difference in VPT; VAS, Michigan Neuropathic Screening Inventory, and ABI (P < 0.05).

Conclusion: We conclude that novel laser shoe photobiomodulation using “laser shoe” effectively reduces peripheral neuropathic pain. It is also effective in reducing average and maximum plantar pressure. Reduction in neuropathic pain and improvement in plantar pressure distribution can reduce further complications.

  5. Prevalence of Cardiac Autonomic Neuropathy in Type II Diabetes Mellitus Top

Linda P. Johnson*, R. Shanmugasundaram, Pravin Selvam, Prasanna Vinayak

*Vinayaka Mission's Kirupananda Variyar Medical College & Hospital, Salem, Tamil Nadu, India

E-mail: [email protected]

Introduction: Diabetes is becoming a global pandemic disease due to adverse lifestyle changes such as reduced physical activity and excess calorie intake. Cardiac autonomic neuropathy (CAN) is often an underdiagnosed complication of diabetes mellitus (DM) and is associated with increased mortality and morbidity.

The objective is to study the prevalence of CAN in type II Diabetes and its association with various variables.

Methods: An observational study with 100 patients with clinically diagnosed type II diabetes. Clinical tests for detection of diabetic CAN were checked for the patients who were selected, and the statistical study was done by using Student's t-test and logistic regression analysis.

Results: It was observed that age (odds ratio [OR] = 1.70; 95% confidence interval [CI] = 1.15–2.50; P < 0.05), duration of diabetes (OR = 1.42; 95% CI = 1.26–1.60; P < 0.05), and estimated glomerular filtration rate (eGFR) (OR = 1.61; 95% CI = 1.43–1.83; P < 0.05) were significantly associated with CAN.

Conclusion: Improving glycemic control and managing lifestyle changes are the mainstay of treatment, which generally slow the progression of CAN rather than reversing it. Age, duration of diabetes, and eGFR were significantly associated with CAN.

  6. Role of Increased Blood Sugar in Acute CVA Patients Top

S. Neelima*, R. Shanmugasundaram, Pravin Selvam, Prasanna Vinayak

*Vinayaka Missions Kirupananda Variyar Medical College & Hospitals, Salem, Tamil Nadu, India

E-mail: [email protected]

Introduction: As age progresses, the incidence of cerebrovascular accidents increases. There are many factors associated with poor prognosis in patients with CVA. Increased blood sugar is one of the various factors that affect the outcome in CVA patients. It is therefore of utmost significance to reduce the blood sugar values in patients who had CVA.

This study mainly focuses on the relationship of increased blood sugar in patients admitted to the hospital within 1 day of the onset of cerebrovascular accidents.

Methods: All individuals above 40 years of age who presented to the hospital within 1 day of the onset of CVA were included in the study. This study design is a type of cross-sectional analytical study design and was conducted for 1 year. Patients presenting with the first episode of CVA and whose blood sugars are checked within 1 day of CVA are included in the study.

Results: The morbidity and mortality in CVA patients with increased blood sugar values were found to be high among the study participants than CVA patients with normal blood sugar values.

Conclusion: It is observed that there is a high association of increased blood sugar among CVA patients on presentation which further leads to increased morbidity and mortality. It is therefore essential to detect increased blood sugar in the early management of CVA. Increased blood sugar can be considered a predictor of poor prognosis in CVA patients

  7. Association of High Fasting Blood Sugar and Diabetic Retinopathy in Type 2 Diabetes Patients Top

S. Neelima*, R. Shanmugasundaram, Pravin Selvam, Prasanna Vinayak

*Vinayaka Missions Kirupananda Variyar Medical College & Hospitals, Salem, Tamil Nadu, India

E-mail: [email protected]

Introduction: Diabetic retinopathy is a microvascular complication of diabetes which can even lead to blindness if untreated. It is essential to screen for diabetic retinopathy even though it is not commonly done. Checking fasting blood sugar (FBS) is easily accessible and affordable.

This study mainly focuses on the association between high FBS and diabetic retinopathy. It aims at delaying or preventing the progression of diabetic retinopathy by controlling the FBS.

Methods: All individuals above 50 years of age, diagnosed with type 2 diabetes, were included in the study. This study design is a type of observational study design conducted for a period of 1 year. Individuals with fasting blood glucose levels below 126 mg/dl and <4 years of diagnosis with type 2 DM were not included in the study. Individuals with diabetic retinopathy should have intraretinal hemorrhages, retinal microaneurysms, or any intraretinal microvascular abnormalities.

Results: The incidence of diabetic retinopathy in type 2 diabetes patients with high FBS values was high among the study participants.

Conclusion: The higher the FBS values, the higher the incidence of diabetic retinopathy in type 2 diabetes patients. It is helpful in screening and detecting the risk of diabetic retinopathy.

  8. White Rice with Ghee Does Not Increase Blood Sugar Level in Type 2 Diabetes Patients Top

Swati Khartode*, Sushant Shinde

*Vishwaraj Hospital, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: India is second largest with type 2 diabetes globally. Diabetes is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion or insulin action. Rice is the staple food of over half of the world's population and 90% of Asians, having multiple nutritional benefits and medicinal properties.

The objective is to assess the improvement in blood sugar level in diabetic patients by including white rice and ghee along with diabetic diet.

Methods: An experimental study with clinical trial performed at “Vishwaraj Hospital,” Pune, from May 2022 to December 2022 to correct blood sugar level in type 2 diabetes patients by nutritional intervention of white rice which was cooked in an open vessel with ghee. Appropriate ethical approval was obtained from the Institutional Ethics Committee, also registered under the Clinical Trials Registry of India with Registration Number: CTRI/2022/05/042533. All 103 enrolled diabetic patients were provided written and verbal information of method of preparation, after taking signature on consent form. After consuming white rice and ghee together, follow-up had taken every 15th day by telephone, whether patients followed recommended dose of white rice, ghee, and correct method of cooking till 90 days. After 90 days of this intervention, all patients were asked to repeat glycated hemoglobin (v) blood test to compare their previous reports.

Results: Statistical analysis was done by the paired t-test which compares the means of two measurements of HbA1c taken from the same individual, i.e., paired observations; the purpose of the test is to determine whether there is statistical evidence that the mean difference between paired observations is significantly different from zero. Out of 103 participants, only 14 participants had increased HbA1c level after 3 months; HbA1c level of 89 participants was either same like before intervention or decreased.

Conclusion: This study concluded that white rice prepared with ghee in an open vessel does not increase blood sugar level in type 2 diabetes patients.

[TAG:2]9. Phase-IV, Multicentric, Open-label, Comparative Clinical Trial to Evaluate Safety, Tolerability, and Efficacy of Oral Tablets of Fixed-dose Combination of Alogliptin and Metformin Hydrochloride versus Alogliptin in the Treatment of Type 2 Diabetic Mellitus[/TAG:2]

Abhijit Anil Trailokya*, Santosh Kale

*Indoco Remedies Ltd., Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: The study aimed to evaluate the safety, tolerability and efficacy of the fixed-dose combination (FDC) of alogliptin plus metformin in treatment of type 2 diabetic mellitus (T2DM).

Methods: A multicenter, open-label, randomized, comparative, parallel-group, phase IV clinical study. Out of 344 patients enrolled, 166 patients received FDC of alogliptin + metformin and 178 received alogliptin. The duration of the study was 180 days and follow-up on 30, 60, 90, and 180 days. Glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and prandial plasma glucose (PPG) were analyzed at the end of 180 days. Safety evaluations were performed by assessing AE, SAE, safety lab tests, and vitals.

Results: After 6 months, the mean reduction of HbA1c from baseline of 8.17 ± 0.57 was −2.07 (P < 0.001). At 6 months, FPG reduced from 196.59 ± 34.48 to 92.94 ± 8.50 in the alogliptin plus metformin group with a mean reduction of −103.65 (P < 0.001). Whereas, in the alogliptin group, FPG reduced from 210.64 ± 20.00 to 150.32 ± 22.06 with a mean reduction of −60.32 (P < 0.001). There was a mean reduction of PPG by −143.11 (P = 0.001) from baseline of 286.38 ± 19.75 to 143.27 ± 8.76 after 6 months in the alogliptin plus metformin group while a mean reduction of PPG by −89.36 (P < 0.001) from baseline value of 283.88 ± 20.84 to 194.52 ± 24.58 after 6 months in the alogliptin group. Twenty-five out of 166 (15.10%) patients experienced 10 adverse events in FDC of alogliptin plus metformin and 23/178 (12.90%) patients experienced 10 adverse events in the alogliptin group. No SAE was reported in both the treatment groups. All the reported adverse events were mild in severity.

Conclusions Alogliptin and FDC of alogliptin + metformin were found to be well tolerated without any serious adverse event. Alogliptin and FDC of alogliptin + metformin is found to be a promising option in management of T2DM in relation to safety and efficacy

  10. Glycemic Variability Using Ambulatory Glucose Profile in Type II Diabetic Patients Top

K. Kirubhakaran, Hamsavardhini, Gandru Hemanth Kumar*

*Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem, Tamil Nadu, India

E-mail: [email protected]

Introduction: Diabetes is a metabolic disorder, which has multiple etiologies. Chronic hyperglycemia is a characteristic feature and disruption of metabolism of carbohydrate, fat, and protein occurs. Unlike glycated hemoglobin (HbA1c), we can directly observe and quantify glycemic variations using CGM and offer the possibility of recording. In spite of the fact that diurnal glucose patterns can be monitored through this method, such data often remain unmanageable. Hence, an analysis of CGM data is needed that is standardized and will produce the significant patterns of blood glucose variations which are also not complicated to understand. To adequately understand glycemic variability is a remarkable task and it can be achieved only through a precise and standardized method of collection and processing of data from blood glucose.

Methods: An observational study in which 50 diabetic patients were selected taking into consideration by inclusion and exclusion criteria. Detailed history was taken, clinical examination was done as per pro forma, and the necessary investigations were done.

Results: Glycemic variability over the 14 days of follow-up of the study participants can be seen that there was a gradual decrease in the glycemic values over the 2 weeks of follow-up. Nearly two-third of patients had high glycemic variability and 32.0% of patients had moderate glycemic variability. It shows a strong positive correlation between fasting blood sugar (FBS), postprandial blood sugar (PPBS), and HbA1c with average glycemic variability.

Conclusion: Ambulatory blood glucose monitoring is considered to be an effective tool which empowers the patients to monitor and judge their glucose levels on a daily basis which makes it more comprehensive and makes the patient aware on their diabetic control. There was a strong positive correlation for the FBS, PPBS, and HbA1c with the average glycemic variability and it was found to be statistically significant (P < 0.001).

  11. Saroglitazar Effectively Reduces Metabolic Parameters in Patients with Diabetic Dyslipidemia with Elevated Liver Enzymes – A 36-month follow-up Indian Study Top

Gaurav Chhaya*, Kunal Jhaveri

*Shivam Medicare Clinic, Ahmedabad, Gujarat, India

E-mail: [email protected]

Introduction: Saroglitazar has been studied multiple times in diabetic dyslipidemia for short duration of therapy even up to 58 weeks in Indian patients. This study is a long-term follow-up and establishing for the first time the 36-month clinical safety and efficacy of saroglitazar 4 mg once daily in patients with diabetes and hypertriglyceridemia with elevated liver enzymes in a real-world scenario.

Methods: In total 64 diabetic patients with serum TG >150 mg/dl, 4 mg saroglitazar was prescribed for 36 months. In that group of patients, we identified that 16 patients had elevated liver enzymes: both alanine transaminase (ALT) and aspartate transaminase (AST). Metabolic parameters of patients were considered for final evaluation having both baseline and follow-up values of fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), glycated hemoglobin (HbA1c), and lipid profile along with liver enzymes as well. Descriptive data analytics has been carried out in the present study and was analyzed by appropriate statistical tests.

Results: At the end of 36 months, metabolic parameters such as TG, FPG, PPPG, HbA1c, ALT, and AST were reduced significantly from baseline. Regarding safety analysis, saroglitazar was to be found safe without having any major adverse events during 36 weeks of study duration. Liver enzymes ALT and AST were both reduced from baseline, the ALT reduction being significant (P < 0.001). Serum creatinine was not adversely affected during this observational study.

Conclusion: High TG is considerably associated with diabetes mellitus and elevated liver enzymes, a 36-month use of saroglitazar, a dual PPAR receptor agonist which significantly reduces lipid and glycemic parameters along with elevated liver enzymes in Indian diabetic patients.

  12. Clinical Correlates and Pathology of Nondiabetic Renal Disease in Type 2 Diabetes Mellitus Top

J. Josephin Antoniammal*, Sara

*St.Johns Medical College and Hospital, Bangalore, Karnataka, India

E-mail: [email protected]

Introduction: Nondiabetic renal disease (NDRD) is frequent in type 2 DM. Differential diagnoses of diabetic nephropathy (DN) and NDRD in diabetic patients are of considerable significance for appropriate management.

Methods: Fifty patients, aged over 18 years with diabetes and biopsy-proven NDRD, were enrolled in the study. The baseline characteristics and laboratory investigations were charted. The types of renal involvement were documented and associations of NDRD were assessed.

Results: The mean age was 55 ± 12 with a male preponderance (66%). The indications for renal biopsy were gross/microscopic hematuria, acute urinary sediment, nephrotic range of proteinuria, declining renal function in the absence of DR, and sudden unexplained deterioration of renal function (elevated creatinine, decreased GFR, and proteinuria). Of the 50 patients with NDRD, 36% had coexisting DN. The most common NDRD was IgA nephropathy followed by membranous. The presence of diabetic retinopathy was higher in NDRD with RD (16%). The duration of diabetes was higher in NDRD with DN.

Conclusion: It is important to consider renal biopsy in patients with rapidly worsening renal function and urinary examination features not typical of DN. The presence of retinopathy should alert the clinician of coexisting DN.

  13. Glycemia, Metabolism, and Hemoglobin: Exploring Relationship with Estimated Glomerular Filtration Rate in Type 2 Diabetic Nephropathy Top

Megha Nataraj*, G. Arun Maiya, Shankar Prasad Nagaraju, Barkur Ananthakrishna Shastry, N. Shivashankara Kaniyoor, Sahana Shetty

*Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India

E-mail: [email protected]

Introduction: Diabetic nephropathy (DN), an insulin-resistant microvascular complication of type 2 diabetes mellitus, has implications for metabolic health. Renal manifestations of kidney dysfunction include protein energy loss, malnutrition, anemia, water retention, and sarcopenia. These symptoms have been observed in people with chronic kidney disease and end-stage renal disease, which alter homeostasis. The objective of the study was to determine the relation of estimated glomerular filtration rate (eGFR) with glycemic parameters, metabolic rate, energy expenditure, and hemoglobin level in individuals with type 2 DN.

Methods: The cross-sectional study used a convenience sampling method. Inclusion criteria comprised participants who were physicians diagnosed with type 2 DN (Stages 1, 2, 3A, 3B, and 4) of either gender, in age group 45–70 years, visiting on an outpatient basis to Kasturba Hospital, Manipal, during the period of January 2021 to December 2022. The basal metabolic rate (BMR) and total daily energy expenditure (TDEE) were calculated online using the Mifflin-St Jeor equation. Resting metabolic rate (RMR) was measured using the bioimpedance analyzer during hospital visit in fasting state. The eGFR was determined using the CKD-EPI creatinine-based race-free equation.

Results: Sixty participants (female = 8; male = 52) with mean age 58.6 ± 7.62 years and eGFR: 57.1 ± 16.0 ml/min/1.73 m2 were screened and provided consent for participation. The Pearson's correlation coefficient between eGFR and glycemic parameters showed a positive correlation for HbA1c (r = 0.385**; P = 0.002) and FBG (r = 0.387**; P = 0.002) with no correlation for PPBG (r = 0.247; P = 0.057). A positive correlation of eGFR was found with BMR (r = 0.316*; P = 0.014) and TDEE (r = 0.281*; P = 0.029) but not with RMR (r = 0.251; P = 0.053). eGFR showed a strong positive correlation with hemoglobin (r = 0.563***; P < 0.001).

Conclusion: The study found a correlation between eGFR and glycemic parameters, metabolic rate, and hemoglobin among individuals with type 2 DN.

  14. A Cross-sectional Study the Effect of Glycosylated Hemoglobin on the Severity of Acute Ischemic Stroke and Functional Outcome in Rural India Top

Mishra Aniket Suryamani*, S. R. Rangabashyam, C. Arulmurugan, G. Anandkumar

*Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Salem, Tamil Nadu, India

E-mail: [email protected]

Introduction: Stroke is one of the most frequent cause of mortality and one of the most common causes of disability worldwide. Diabetes mellitus is a well-recognized risk factor of stroke where patients with diabetes experience 1.5–3 times higher risks of stroke as compared to people without diabetes. In the Framingham study, the incidence of cerebral infarction increases by 2.5 folds in male patients with diabetes and 3.6 folds for women with diabetes. Existing literature indicates that patients with diabetes mellitus are not only at increased risks of ischemic stroke but also portend significant mortality caused by stoke. Moreover, compared to nondiabetic subjects, the pattern of stroke is different in subjects with diabetes.

The objective was to study the effect of glycosylated hemoglobin (HbA1c) on the severity of acute ischemic stroke and functional outcome.

Methods: The study is a cross-sectional study with 3 months follow-up. Three hundred acute ischemic stroke patients were studied. One hundred and fifty patients were cases with diabetes mellitus. The remaining 150 patients were controls without diabetes. Cases were sub-categorized to good glycemic control (HbA1c≤7%) and poor glycemic control(HbA1c>7%).

Results: Around 75% patients of poor glycemic control group has severe stroke severity (>12 NIHSS) at admission and 60% of good glycemic control patients has moderate stroke severity (NIHSS = 7–12). Approximately 93% of good glycemic control group and 80% of control group patients without diabetes have functional independence at 3 months of follow-up. Seventy-five percent of poor glycemic control patients have functional dependence at 3 months of follow-up.

Conclusion: Glycemic control has a significant association on severity and outcome of ischemic stroke patients with diabetes. With achievement of near-normal glycemic status in population with diabetes. the stroke severity and functional outcome levels might be brought to the same extent of that observed in population with diabetes.

  15. Prevalence of Hypogonadism among Patients with Type 2 Diabetes in India Top

A. G. Unnikrishnan, Shriram Mahadevan, Banshi Damodarlal Saboo, Anirban Majumdar, Ravi Kant Saraogi, Shanmuga Sundar, Anantharaman Ramakrishnan, Deep Dutta, Indraneel Basu, Arpan Dev Bhattacharya, Saptarshi Bhattacharya, Prakadeesh Bharathi*

*Abbott Healthcare India Ltd, Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: Male hypogonadism is a clinical and biochemical syndrome caused by inadequate synthesis of testosterone, and its prevalence is increasing among patients with type 2 diabetes (T2D). In the absence of prevalence data by confirmatory methods, this study was conducted to evaluate the prevalence of hypogonadism among Indian men with T2D by symptomatic and biochemical estimation of testosterone levels.

Methods: This multicenter, prospective, observational study was conducted at 10 sites in India wherein hypogonadism was screened using the androgen deficiency in the aging male (ADAM) questionnaire and testing of serum total testosterone levels. Men aged 30–65 years with >5-year history of T2D with or without obesity were included. Hypogonadism was defined as total testosterone.

Results: In all, 598 patients with T2D were enrolled (mean [standard deviation] age and body mass index of 50.4 {9.12] years and 26.5 {3.58} kg/m2, respectively), of which 14.6% were obese. Based on the ADAM questionnaire, 81.4% of patients were symptomatically positive for hypogonadism. With 2 confirmatory screening tests for serum testosterone, the prevalence of hypogonadism (cutoff <300 ng/dL) was found to be 8.5%, which was highest (33.0%) in the age category of 50–59 years. The prevalence among obese and nonobese patients was 10.3% and 7.1%, respectively.

Conclusion: The study findings showed that patients with T2D had a significant prevalence of hypogonadism in India, thereby indicating a need for routine screening for hypogonadism among patients with T2D to address underlying comorbidities and improve disease-related outcomes.

  16. Prevalence of Sarcopenia in Diabetic Male Patients above the Age of 40 and Its Correlation with Duration of Diabetes in a Tertiary Care Center Top

A. Sathvika*, J. S. Kumar

*SRM Medical College, Chennai, Tamil Nadu, India

E-mail: [email protected]

Introduction: Sarcopenia is a progressive and generalized skeletal muscle disorder involving the accelerated loss of muscle mass and strength that is associated with increased adverse outcomes including falls, functional decline, frailty, and mortality. It is more commonly seen in the elderly population. Type 2 diabetes mellitus represents a major health burden for the elderly population besides micro- and macrovascular complications. Sarcopenia has been described as a new diabetic complication in elderly people.

Methods: Diagnosis of sarcopenia was based on (the Asian Working Group for Sarcopenia). Low muscle mass, along with either low muscle strength, low physical performance, or both, are indicators of sarcopenia.For males, a body composition monitor reading of <7.0 kg/m2 is considered as low muscle mass, handgrip strength <26 kg as low muscle mass strength, and the six-meter gait speed less than 0.8 m/s is defined as poor physical performance.

Results: In the study conducted, it was found that the prevalence of sarcopenia was 23.2% in male patients with diabetes above the age of 40 years. The development of sarcopenia was directly related to the diabetic age. Single HbA1c value had no correlation with sarcopenia.

Conclusion: As sarcopenia is a reversible condition and is causing a major effect on the quality of life, further interventions can be done with muscle strengthening exercises and diet modification to see improvement in patients.

  17. Physical Activity and Glycemic Profiling of Women with Gestational Diabetes Mellitus Top

Savni Apte*, G. Arun Maiya, Preetha Ramachandra, Shyamala Guruvare, Shashikala K. Bhat

*Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India

E-mail: [email protected]

Introduction: Gestational diabetes mellitus (GDM) is hyperglycemia detected for the first time during the period of gestation. To meet the demands for the development of the fetus, the mother's body undergoes metabolic and endocrine changes resulting in a diabetogenic environment. The pathomechanism of GDM is the combined effect of reduced insulin production and increased peripheral insulin resistance. Insulin resistance increases as gestation progresses, hence GDM is mostly diagnosed between the 24th and 28th weeks of gestation.

Methods: Global Physical Activity Questionnaire, glycemic parameters, and other maternal-fetal health-related outcomes were assessed for 72 participants after obtaining their consent and were analyzed to create the health profile of the women diagnosed with GDM. All the women diagnosed with GDM by oral glycemic tolerance test method were included in the study.

Results: The mean age of the participants was 30.96 ± 7 years, and the mean gestational age was 29.42 ± 5 weeks. A total of 31 participants were overweight, 17 were obese, 23 had normal body mass index, and one was underweight. Among 72 women, 69 were sedentary, 3 were moderately active, and none were performing a vigorous level of physical activity. The episodes of urinary tract infection were the highest among all the other health problems associated with GDM. Based on the mean of the values of fasting blood glucose, 30 participants had fasting blood glucose of more than 92 mg/dL. The glycated hemoglobin ranged between 5.1% and 5.5%.

Conclusion: Impaired glycemic control impacts maternal and fetal health. The profiling may help us understand the other health parameters to be taken into the consideration and the mechanism through which they are impacted due to high glycemic index.

  18. Self-management Adherence and Support System in Type 2 Diabetes Patients in a Selected Tertiary Health-care Center, Kolkata, West Bengal: A Cross-sectional Survey Top

Shampa Sarkar Gupta*, Uma Rani Adhikari

*Neotia Academy of Nursing Kolkata, West Bengal, India

E-mail: [email protected]

Introduction: Diabetes mellitus is a global burden for both developed and developing countries. It is the most common cause of death and disabilities, which can be avoided by appropriate diet, physical activities, medication, regular glucose monitoring, and follow-up. Social and family supports are two important aspects in self-management behaviors as well as glycemic control. This study aims to assess the effect of support systems in diabetic self-management adherence.

Methods: A cross-sectional survey was carried out with 150 diabetic patients in August–September 2021 at Endocrinological OPD at a selected Govt. Hospital, Kolkata, West Bengal. Data were collected through quasi-random sampling. Background information and support system of the participants were assessed through a validated semi-structured interview schedule. Adherence on diabetic self-management was assessed through a standardized Diabetic Self-Management Questionnaire.

Results: Sixty-four percent of the participants were middle-aged adults. 57.3% were from urban community, 84.7% were married, and 54.7% belonged to nuclear family. 40.7% studied up to primary level of education and 43.3% were from low socioeconomic group. Thirty-eight percent of the participants were suffering from diabetes for more than 10 years, and 54.7% were having family history of diabetes. 56.0% of the participants' fasting blood sugar (FBS) was 180 mg/dl. Fifty-two percent of participants had optimal diabetic self-management adherence with a mean of 6.15 and standard deviation of 1.22. Data revealed a significant association between diabetic self-management adherence with family support (χ2(2) = 11.02, P = 0.04) and glycemic control in FBS (X2(1) = 3.60, P = 0.05).

Conclusion: Adherence in diabetic self-management is very important in glycemic control for diabetes patients, and family support is one of the keys to enhance diabetic self-management adherence.

  19. A Comparative Study of Echocardiographic Evaluation of Diastolic Dysfunction in Normotensive Patients among Early-onset versus Late-onset Type 2 Diabetes Mellitus Top

Varun Arumugham*, K. Kirubhakaran, S. R. Ranga Bashyam

*Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem, Tamil Nadu, India

E-mail: [email protected]

Introduction: Diabetes mellitus is one of the major risk factors for diastolic heart failure. Mortality rates among the patients with diastolic heart failure range from 5% to 8% annually. Left ventricular diastolic dysfunction thus represents the first stage of diabetic cardiomyopathy preceding changes in systolic function, thus reinforcing the importance of early examination of ventricular function in individuals with diabetes. The diastolic abnormalities are present in diabetic patients even without any diabetic complications; it is the earliest and specific functional abnormality and can affect patients who are free of macrovascular complications, newly diagnosed diabetes mellitus, or even in those with a disease <1 year.

Methods: A cross-sectional study was conducted on 1000 diabetic patients attending the Outpatient Department of VMKVMCH. Patients with other comorbidities such as hypertension, valvular heart diseases, and abnormal electrocardiogram changes were excluded. The data include the duration of diabetes and measurements of fasting blood sugar, postprandial blood sugar, and glycated hemoglobin and patients were made to undergo echocardiography, in which the 2D measurements, M mode measurements, pulse wave, and tissue Doppler measurements were measured.

Results: About 65% of the type 2 diabetes patients had diastolic dysfunction, and among them, majority (81%) had grade I diastolic dysfunction and 17% had grade II and only 2% of the patients had grade III diastolic dysfunction. The increasing age, female gender, and the duration of diabetes were the factors contributing for the development of diastolic dysfunction in the study population. Earlier age of diabetes onset leads to increased duration of diabetes leading to increased occurrence of diastolic dysfunction.

Conclusion: It is suggested that all patients of diabetes should be routinely and repeatedly subjected to 2D echocardiographic assessment of cardiac functions in the long-term management of this metabolic disease. This has important therapeutic implications and helps physicians planning early interventional strategies. Thus, diastolic dysfunction can be used as an early indicator, as it is a precursor to increased LV hypertrophy and clinical LV dysfunction.

  20. Comparative Assessment of Safety and Efficacy of Dapagliflozin versus Basal Insulin in Stabilizing Glycemic Variability in Patients with Type II Diabetes Mellitus Inadequately Controlled on Triple-drug Combination Top

Deepak Sadashiv Bhosle*, Bhakti Chandekar, Vandana Bhosle

*Deogiri Diabetes Care Center & MGM Medical College, Aurangabad, Maharashtra, India

E-mail: [email protected]

Introduction: Irrespective of good control of glycated hemoglobin (HbA1c), glycemic variability has been strongly associated with complications of diabetes. Large glucose fluctuations may increase oxidative stress and inflammation, which in turn cause endothelial cell damage and vascular complications.

Methods: A 1-year prospective, open-label, double-arm, interventional study was conducted at Deogiri Diabetes Care Centre, Aurangabad. Patients aged 18–65 years (n = 100) inadequately controlled on triple-drug therapy for type 2 diabetic mellitus (T2DM) willing to participate were included in the study. The patients were randomized into two groups, Group A (n = 50) received dapagliflozin 10 mg OD and Group B (n = 50) received basal insulin as the fourth glucose-lowering agent for 3 months. On receiving voluntary consent from patients, “FreeStyle Libre Pro®” Ambulatory Glucose Monitoring sensor was applied on the patients for 14 days before initiating the therapy and 3 months posttherapy. The AGP report combining all the data elements including coefficient of glycemic variability, TIR%, TBR% and TAR% and glucose management index, changes in glycemia parameters such as fasting blood sugar, postprandial blood sugar, and HbA1c were assessed at baseline and at the end of 3 months.

Results: Significant (P < 0.05) reductions were observed in glycemia parameters at the end within both the groups, with Group B having a statistically significant reduction when compared with Group A. TAR, TIR, and TBR values improved significantly within both the groups, but Group B patients have shown a statistically significant improvement on comparison with Group A patients

Conclusion: CGM is considered one of the best ammunitions for diabetes management as it assists in ascertaining the tailored approach to pharmacological therapy and lifestyle modifications. Although insulin and dapagliflozin both provide promising effects in reducing glycemic parameters and stabilizing glycemic variability, insulin is more effective as compared to dapagliflozin in patients with T2DM who are inadequately controlled on triple-drug therapy.

  21. Prospective Study on the Prevalence of Primary Aldosteronism in Type 2 Diabetes Patients with Resistant Hypertension at a Tertiary Care Hospital Top

R Manoj Kumar Reddy*, Raman Boddula, Aashish Reddy, Kaushal Sheth

*Yashoda Hospital, Secunderabad, Telangana, India

E-mail: [email protected]

Introduction: Primary aldosteronism is the most common form of secondary hypertension, with a prevalence rate of 2%–19%, and rates of prevalence increase with the severity of hypertension. Data on the prevalence of primary aldosteronism in diabetic population are limited.

Methods: Eighty-five adult type 2 DM patients with resistant hypertension were included in the present study. Treatment-resistant hypertension was defined as suboptimal blood pressure control despite 3 or more antihypertensive medications, or hypertension requiring 4 or more antihypertensive medications to normalize blood pressure. Plasma aldosterone concentration and direct renin concentration were estimated by CLIA. Patients were considered positive for screening test if they meet all 3 criteria: PAC > 10 ng/dl, DRC <12 μIU/ml, and ARR >2.5 ng/dl/μIU/ml (equal to 30 ng/dl/ng/ml/h). Patients with positive screening will undergo confirmation by seated saline infusion test.

Results: There were no statistically significant differences with regard to age, gender, duration of diabetes mellitus, duration of hypertension, SBP, DBP, and serum potassium between subjects tested positive in screening test for primary aldosteronism and in subjects who tested negative for primary aldosteronism. Eighteen out of 85 tested positive for primary aldosteronism in screening test and thus the prevalence by screening is 21%. Two out of 18 screening-positive subjects had spontaneous hypokalemia, PAC >20 ng/dl, and DRC <12 μIU/ml and thus confirmed to have primary aldosteronism without the need of any confirmatory testing. Three out of 18 screening-positive subjects underwent seated saline infusion test and two out of the three had nonsuppression of aldosterone (>6 ng/dl) and were confirmed to have primary aldosteronism. The rest of the screening-positive patients were not willing for confirmatory testing. Thus, the prevalence by confirmatory testing in our study was 4.7% (4 out of 85).

Conclusion: The prevalence of primary aldosteronism in type 2 diabetic patients with resistant hypertension is minimum 4.7% (as all the screening-positive patients did not undergo confirmatory testing) from our study.

[TAG:2]22. A Multicenter, Randomized, Prospective, Double-blind Phase III Study to Evaluate Efficacy, Safety, and Tolerability of FDC Teneligliptin 20 mg + Dapagliflozin 5 mg/10 mg versus Monotherapy of Dapagliflozin 10 mg and Teneligliptin 20 mg in Type 2 Diabetes Mellitus Patients with Inadequately Controlled on Metformin[/TAG:2]

Manasi Brid, Abhishek Mane*, Sachin Suryawanshi, Vibhuti Jadhao, Hanmant Barkate

*Glenmark Pharmaceuticals Ltd, Dombivli, Maharashtra, India

E-mail: [email protected]

Objectives: Recent clinical evidences show that dipeptidyl peptidase-4 (DPP-4) inhibitors and sodium glucose cotransporter-2 (SGLT2) inhibitors therapy is an effective combination for type 2 diabetic mellitus (T2DM) treatment due to their complementary effects. Among these classes, dapagliflozin and teneligliptin are very commonly used in India concomitantly. Hence, the study was planned to evaluate the efficacy, safety, and tolerability of teneligliptin 20 mg (DPP 4 inhibitor) + dapagliflozin 5 mg/10 mg (SGLT2 inhibitor) combination.

Methods: Multicentric, randomized, prospective, double-blind phase III clinical study was planned to evaluate the safety, efficacy, and tolerability of teneligliptin 20 mg + dapagliflozin 5 mg/10 mg FDC versus monotherapy of dapagliflozin 10 mg and teneligliptin 20 mg in T2DM patients, inadequately controlled on metformin. Total 296 T2DM patients with HbA1c level between ≥7.5% and ≤10.0% were randomized from 13 centers across India. The primary and secondary endpoints were change in HbA1c and FPG, PPG, % of patients achieving HbA1c <7.0%, mean change in body weight from baseline to week 24 respectively.

Results: The primary and secondary endpoints showed significantly more change in FDC groups compared to monotherapies from baseline to week 24. Change from baseline at 24 weeks P value T+D(20/5) T+D(20/10) T(20) D(10) HbA1c (%) -1.5 -1.6 -0.9 -1.1 <0.0001 FPG (mg/dl) -40.3 -45.6 -23 -25 <0.0001 PPG (mg/dl) -68.2 -78 -51 -55 <0.0001 % of patients achieving HbA1c < 7% 39 43 21 25 T=Teneligliptin, Weight loss at 24 weeks was significant (P < 0.0001) except in teneligliptin 20 mg monotherapy arm. Hypoglycemic episodes were observed in 2.70% of cases on dual therapy while 1.35% on monotherapy, all were of mild severity and resolved by the end of the study.

Conclusion: Teneligliptin 20 mg and dapagliflozin 5/10 mg FDC have superior and significant control on glycemic parameters compared to respective monotherapies and combination was well tolerated.

  23. Efficacy and Safety of Zoledronate, Denosumab, and Teriparatide in Postmenopausal Women with Type 2 Diabetes and High Risk of Fragility Fractures: Interim Analysis of a Pilot, Open-labeled, Blinded Endpoint Randomized Controlled Trial Top

Rimesh Pal*, Trupti N. Prasad, Sanjay K. Bhadada, Veenu Singla, Sant Ram, Neelam Aggarwal, Ashok Kumar, Debajyoti Chatterjee

*Post Graduate Institute of Medical Education & Research, Chandigarh, India

E-mail: [email protected]

Introduction: People with type 2 diabetes (T2D) are at high risk of fragility fractures, however, there are no RCTs evaluating the efficacy/safety of anti-osteoporotic drugs as a primary endpoint in T2D.

Methods: Hence, we conducted a pilot prospective, open-labeled, blinded-endpoint RCT (CTRI/2022/02/039978) wherein consecutive postmenopausal women with T2D were screened. Subjects with glycated hemoglobin (HbA1c) 7%–10%, estimated glomerular filtration rate (eGFR) >45 ml/min/1.73 m2, and prior history of fragility fracture or at high risk of fragility fractures (BMD T-score [adjusted for diabetes] at lumbar spine/femoral neck ≤−2.5 and high FRAX score) were randomized (1:1:1:1) to receive either daily teriparatide, yearly zoledronate, biannually denosumab or only standard of care (calcium 1000 mg/day, cholecalciferol 1000 IU/day; control arm). The primary endpoints were change in BMD and frequency of incident fractures at 18 months. The secondary endpoint was change in HR-pQCT parameters measured at distal radius and distal tibia (XtremeCT II). Herein, we have presented the HR-pQCT data at 6-month follow-up.

Results: Out of 127 subjects randomized, 74 have completed 6 months of follow-up (teriparatide n = 16, zoledronate n = 21, denosumab n = 22, control n = 15). There were no statistically significant differences in age, HbA1c, eGFR, calcium, phosphate, ALP, 25(OH)D, PTH, PINP, CTX, areal BMD, TBS, or HR-pQCT parameters (distal radius and distal tibia) between 4 groups at randomization. At 6 months, there was no significant difference in HbA1c between 4 groups; PINP/CTX rise was significantly higher in teriparatide arm compared to zoledronate, denosumab, or control arms. With regard to HR-pQCT, there were no statistically significant differences in microarchitectural parameters at distal radius between 4 arms at 6 months. However, at the distal tibia, zoledronate faired significantly better than control in terms of total volumetric BMD and cortical volumetric BMD.

Conclusions: Zoledronate led to significant microarchitectural improvement in postmenopausal women with T2D. However, longer duration of treatment and follow-up is required to arrive at robust conclusions.

  24. Effect of Low/Moderate-intensity 15-min Walking Postmeal Coupled with Stretching and Resistance Exercises on Blood Glucose Levels of Chronic Type 2 Diabetes Patients during COVID-19 Lockdown: Observational Study Top

Gauri Tamhankar*, Gauri Samudra, Trupti Patil

*Krishna Institute of Medical Sciences, Karad, Maharashtra, India

E-mail: [email protected]

Introduction: This study is a noninterventional, retrospective observational study on glycemic control of chronic type 2 diabetes mellitus patients during COVID-19 lockdown. We recommended home-based exercises along with postmeal walk to minimize the spikes in blood glucose levels to our patients. The aim was to minimize the undesired effects of sedentary lifestyle.

Methods: Total 98 (47 males and 51 females) subjects with chronic type 2 diabetic mellitus (T2DM) were included in this study. The blood glucose levels of the subjects during the start and 3 months after the lockdown were considered. They were advised to follow the prescribed antidiabetic medication along with routine diet and daily chores. They were prescribed to follow a low/moderate intensity 15 min walk at home, after every meal, coupled with age-appropriate stretching and resistance exercises during the day. After 3 months, the questionnaire was given to all the subjects to know the adherence and the same was analyzed. Fasting, postprandial blood glucose levels, and body weights were documented.

Results: Paired t-test was done to compare weight, fasting sugar, and PP sugar before and after the lockdown period. The mean body weight at the end of the study was significantly less as compared to the initial one. A significant difference was observed in postprandial blood glucose before and after the study. This indicates that the prescribed walking and exercises were effective to control the body weight and postprandial sugar.

Conclusion: It is recommended to couple aerobic exercises with stretching and resistance training in patients with T2DM. Resistance (strength) training may include exercises with free weights, weight machines, or elastic resistance bands. It was also observed that 15-min low/moderate-intensity walking after every meal was beneficial to control the postmeal blood glucose level spike.

  25. Clinical Experience of Usage of Up-titration Metformin (850 mg/day) in Type 2 Diabetes Management: Real-world Evidence Top

Sujeewa Veniwelkola, Damitha Piyadigama, Rasika Amera, Ashish Birla, Tripti Sharma*

*USV Private Limited Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: A global trend toward a higher prevalence of type 2 diabetes mellitus (T2DM) and associated complications, including in Sri Lanka. Metformin is recommended as first-line therapy to achieve glycemic control. However, there is a lack of real-life practice of metformin in the management of patients with T2DM in Sri Lanka.

The aim of this study is to evaluate the clinical effectiveness and safety of metformin (850 mg/day) in T2DM patients.

Methods: This retrospective, multicentric, real-world evidence included patients with T2DM (aged >18 years) receiving metformin (850 mg/day) as initial therapy or as an up-titrated dose. Data related to demographics, glycated hemoglobin (HbA1c) levels, and safety were retrieved from medical records. A paired t-test was used to evaluate the mean change in HbA1c. No ethics committee approval was taken.

Results: A total of 454 patients were included with a mean (standard deviation) age of 57.3 (11.4) years. The proportion of male patients was 54% (n = 241). The mean duration of T2DM was 8.0 years. Obesity (46.0%) and salt intake (41.2%) were the most common risk factors. Peripheral neuropathy (46.9%) was the most common comorbid conditions in patients with diabetes followed by dyslipidemia (60.4%), and hypertension (56.2%). A total of 63.6% of patients required dosage up-titration. Improving HbA1c level (59.0%) and controlling fasting blood glucose (53.7%) were the predominant reason for the up-titration of metformin dosage. The mean HbA1c levels were significantly decreased post-treatment (mean change: 0.9%; P < 0.001). Among 341 patients who experienced body weight changes, a majority of patients had lost weight (89.1%). Adverse events were reported in 9.9% of patients. Physicians rated the majority of patients as good to excellent on the global evaluation of efficacy and tolerability scale (90.1% and 87.5%, respectively).

Conclusion: Metformin (850 mg/day) was an effective therapy in reducing HbA1c and achieving target glycemic control, and was well tolerated.

  26. A Multicenter, Randomized, Comparative Study to Assess Efficacy and Safety of Fixed-dose Combination of Glimepiride, Voglibose, and Metformin Tablets in Comparison to Two-drug Combination Antidiabetic Products in Indian Patients with Type 2 Diabetes Top

Brij Mohan, S. Vasanth Kumar, Prakash Harishchandra Kurmi, Sandeep Kumar Gupta, K. Neelaveni, Bharat Das, Tushar Vidhale, Kartikeya Parmar, Alok Kanungo, Sanjay Saran, Preetam Ahirrao, Balamurugan Ramanathan, Micky Patel, Vivek Arya, Raisa Shaikh, Sapan Behera, Piyush Patel, Dipak Patil*, Lalit Lakhwani, Pravin Ghadge, Suyog Mehta, Sadhna Joglekar

*Sun Pharma Laboratories Limited, Mumbai, India, Maharashtra, India

E-mail: [email protected]

Introduction: Diabetes is a multifactorial disease requiring treatments considering specific factors, such as complementary actions and complexity of regimen.

The objective of the study is to assess the efficacy and safety of three drug fixed-dose combination (FDC) in comparison to two-drug FDCs in patients with type 2 diabetes (T2D).

Methods: This phase IV, multicenter, comparative, randomized, open-label study screened T2D patients receiving metformin ≥1000 mg for at least 12 weeks and had glycated hemoglobin (HbA1c) between 7.5% and 9%. Eligible patients were randomized in 1:1:1 ratio to receive either glimepiride + voglibose + metformin extended-release tablets (1/2 + 0.2 + 500 mg; test) or voglibose + metformin tablets (0.2/0.3 + 500 mg; comparator-1) or glimepiride + metformin tablets (1/2 + 500 mg; comparator-2), twice a day. Dose up-titration was done if HbA1c was >7.5% at week 12. Treatment was continued till week 24.

Results: Of the 458 patients screened, 399 were randomized (test n = 133, comparator-1 n = 135, and comparator-2 n = 131). Baseline HbA1c was ~8.35%. All the treatments showed a significant reduction in HbA1c at weeks 12 and 24. The mean reduction in HbA1c was significantly more in the test group compared to comparator-1 and comparator-2 at week 12 (test vs. comparator-1: −1.02 ± 0.60 vs. −0.68 ± 0.64, P < 0.001, and test vs. comparator-2: −1.02 ± 0.60 vs. −0.88 ± 0.49, P = 0.0154) and week 24 (test vs. comparator-1: −1.57 ± 0.74 vs. −1.11 ± 0.80, P < 0.001 and test vs. comparator-2: −1.57 ± 0.74 vs. 1.28 ± 0.60, P = 0.0002). A reduction of fasting and postprandial glucose at weeks 12 and 24 was significant in all groups (P < 0.0001 each). A significantly greater number of patients achieved HbA1c <7.0% in the test group (P < 0.001 compared to both the comparators). Fewer patients required dose up-titration in the test arm compared to the comparator arms. Overall 49 adverse events (AEs) were reported in 32/399 (8.0%) patients. Two patients had level 1 hypoglycemia. Study medications were well tolerated without any severe/serious AEs.

Conclusion: Triple FDC of glimepiride + voglibose + metformin was superior to comparators in reducing HbA1c at week 12 and week 24. Study medications were safe and well tolerated.

[TAG:2]27. Efficacy and Safety of Triple Fixed-dose Combination of Dapagliflozin + Sitagliptin + Metformin in Indian Patients with Type 2 Diabetes Mellitus: A Phase 3, Multicentric, Randomized, Open-label Comparison with Sitagliptin + Metformin Fixed-dose Combination[/TAG:2]

Mahendra Pal Singh, Sandeep Gupta, Girish Bhatia, Manish Singh, Hemant Gupta, C. Ambrish, Prakash Kurmi, Dinesh Gangwani, J. Naganna, Ravikumar Sethuraman, Vrindavani Dhumal, Sapan Behera, Piyush Patel, Dipak Patil*, Lalit Lakhwani, Pravin Ghadge, Suyog Mehta, Sadhna Joglekar

*Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: Diabetes mellitus, a multifactorial progressive disease, requires multiple agents to achieve optimum control. Fixed-dose combination (FDC) regimen that improves treatment adherence and tolerability provides tight glycemic control, and delays need of insulin therapy is preferred.

Methods: This Phase 3, randomized, open-label study screened type 2 diabetes patients receiving FDC of sitagliptin + metformin (50/500 mg or 50/1000 mg) twice daily (BID) for ≥8 weeks and had glycated hemoglobin (HbA1c) between 7.5% and 11%. Eligible patients were randomized to receive FDC of dapagliflozin + sitagliptin + metformin immediate release (5 + 50 + 500/1000 mg) BID or sitagliptin + metformin (50 + 500/1000 mg) BID for 16 weeks, based on metformin dose at screening. The primary efficacy endpoint was mean change in HbA1c from baseline at week 16. The secondary efficacy endpoints included change in fasting (FBG) and postprandial blood glucose (PPG) and percentage of patients achieving target HbA1c. Safety and tolerability were assessed based on adverse events (AEs) and incidence of hypoglycemia.

Results: Of the 290 patients screened, 273 were randomized (dapagliflozin + sitagliptin + metformin; n = 136 and sitagliptin + metformin; n = 137). The baseline HbA1c was ~8.90%. At weeks 12 and 16, both the groups showed a significant reduction in baseline HbA1c (P < 0.0001). The mean change in HbA1c was significantly more in favor of triple FDC as compared to dual FDC (week 12: −1.37 ± 1.01 vs. −0.77 ± 1.01; P < 0.0001 and week 16: −2.07 ± 1.20 vs. −1.38 ± 1.14; P < 0.0001). A reduction in FBG was also significant in favor of triple FDC (week 12: −39.1 ± 39.14 vs. −27.6 ± 46.14; P < 0.0001 and week 16: −36.9 ± 44.87 vs. −30.6 ± 47.82; P = 0.0065). A reduction in PPG was significantly more in favor of triple FDC compared to dual FDC only at week 12 (−53.0 ± 68.82 vs. −38.7 ± 68.04; P = 0.034). At week 16, significantly more patients achieved HbA1c <7% in triple FDC (48.9% vs. 31.1%; P = 0.0029). Study medications were well tolerated without any severe/serious AEs or hypoglycemia event.

Conclusion: Overall, FDC of dapagliflozin + sitagliptin + metformin IR was superior in providing better glycemic control in comparison to FDC of sitagliptin + metformin, without any safety concerns.

  28. Analysis of Prevalence and Pattern in Screening for Diabetes Mellitus Top

Karuna Rameshkumar*, Bharath Raj, Manoj Kumar

*Mithra Multispespeciality Hospital, Bengaluru, Karnataka, India

E-mail: [email protected]

Setting: A tertiary care hospital in midst of rural area and IT industry on either side. The period of study was from January 1, 2021, to June 30, 2022.

Introduction: We aimed to screen out patients for type II diabetes and prediabetes and to compare and analyze the reporting pattern during the period.

Method: The study included symptomatic patients referred by a physician and OPD patients who consented for diabetes screening. Fasting and postprandial blood sugar levels and hemoglobin A1c were done for all patients by standard methods. Nondiabetic, prediabetic, and diabetic ranges were defined. The demographic details, risk factors, and results of tests were tabulated. The patients who were in the prediabetes range (high risk) were counseled and followed up.

Result : In this cross-sectional study, 682 patients were screened and included among 8253 outpatients (8.3%). The patients were categorized as nondiabetic, prediabetic, and diabetic. One hundred and two patients were in the prediabetic range (14.9%) among which 38 were below 40 years. They were counseled for lifestyle changes including nutrition and followed up. Diabetic patients treated as per guidelines. During postpandemic and follow-up periods, the number of patients screened was 8.5 times higher than pandemic and prepandemic periods.

Conclusion: The results showed that 14.9% of the patients were in prediabetic range and 37% of them were below 40 years. The findings pointed toward the gap between knowledge of risk factors and the need for screening and referrals irrespective of population. However, pandemic increased awareness of comorbidities which resulted in increased number of patients for screening postpandemic and follow-up period. Linking diabetes screening with referrals to lifestyle programs for high-risk individuals will help to reduce disease burden and complications.

  29. The Study of Obesity, Sleep Apnea, and Diabetes Top

Preeti Gholap*, Kedar Korde

*Deenanath Mangeshkar Hospital, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: The incidence of obesity is rising in the last decade in modern Indian society, mostly due to imbalanced nutrition and reduced physical activity. Obstructive sleep apnea (OSA) is a common disorder observed in obese individuals. Both obesity and OSA independently and together add to the risk of many metabolic disorders including diabetes, hypertension, nonalcoholic fatty liver disease, and cardiovascular events. The connection between OSA and obesity is very complex and likely represents an interaction between biological and lifestyle factors; oxidative stress, inflammation, and metabolic dysregulation are involved in pathogenesis of OSA and obesity. Diabetes is connected with OSA and obesity in a bidirectional way. Both obesity and OSA are known as risk factors for development of new diabetes and various other diseases as in metabolic syndrome. Moreover, additional burden of diabetes may add to the problem of OSA due to autonomic and peripheral neuropathy causing neuromuscular incoordination.

Methods: The present study is of 64 patients seen in clinic (OPD basis) from January 2021 to January 2023. All had significant symptoms of snoring and fatigue associated with varying degrees of obesity. A home-based sleep study was performed for all these patients.

Results: A total of 64 patients' data were analyzed based on gender, age, body mass index (BMI), apnea-hypopnea index (AHI), lowest desaturations, and presence of diabetes. Among these, 30 were female and the rest 34 were male. For both genders average BMI more than 30, men seem to have higher AHI as compared to women. With rising AHI, the hypoxia seems to be more severe.

Conclusion: With rising BMI, the AHI and hypoxia both seem to be higher. Since the data were skewed in favor of diabetes, no definite conclusion can be presently drawn. More data are therefore required to further investigate the association of diabetes with OSA and obesity.

  30. β-cell Preservation and Reduction in Insulin Resistance with DPP4 Inhibitors in Type 2 Diabetes Mellitus: An Update on Role of Sitagliptin Top

P. Bharadwaja*, Shruti Dharmadhikari, Neeraj Markandeywar, Amey Mane, Suyog Mehta

*Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: This review intends to examine the evidence regarding the beta-cell preservation and reduction in insulin resistance observed with DPP4 inhibitors, specifically sitagliptin in type 2 diabetes mellitus (T2DM) patients.

Methods: A detailed literature search was conducted using relevant terms in PubMed to identify articles published in the last 10 years.

Results: Appropriate β-cell function and insulin signaling are crucial for maintaining glucose homeostasis in T2DM. Oral sitagliptin, a DPP4 inhibitor, is effective in a wide range of patients with T2DM, including those who are obese, elderly, have kidney problems, and/or have cardiovascular disease. Sitagliptin improves β-cell function and insulin levels by prolonging active incretins and increasing GLP-1 secretion from L-cells. A study by Derosa et al. (2013) reported significant improvements in β-cell function in T2DM patients with sitagliptin/metformin/pioglitazone combination. Findings from a meta-analysis by Lyu et al. (2017) reported that compared with placebo, DPP-4 inhibitors (including sitagliptin) significantly improved HOMA-beta-cell function as monotherapy (weighted mean difference [WMD]: 9.15; 95% confidence interval [CI]: 7.48, 10.81] and as add-on therapy in combination (WMD: 9.04; 95% CI: 5.72, 12.37). Furthermore, patients treated with sitagliptin (100 mg) alone have reported increased GLP-1 levels, contributing to enhanced β-cell function. Furthermore, a study by Kutoh et al. (2020) showed that sitagliptin improved HOMA-R and 20/(C-peptide x FBG) indexes for insulin sensitivity/resistance and the HOMA-B and CPR index measures of β-cell function. Additionally, Reasner et al. (2011) and Tuan DL et al. (2020) reported improved β-cell function, insulin resistance, and blood glucose levels in T2DM patients treated with sitagliptin or sitagliptin plus metformin combination.

Conclusion: Overall, sitagliptin represents a better therapeutic option for the preservation of β-cell function and reduction of insulin resistance in patients with T2DM, and hence, it should be considered as part of a comprehensive treatment plan.

  31. Recent Evidences in Cardiovascular Safety of Sulfonylureas: A Focus on Glimepiride Top

Dinesh Jiwane*, Shruti Dharmadhikari, Neeraj Markandeywar, Amey Mane, Suyog Mehta

*Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: This review intends to examine the recent evidences on the cardiovascular outcomes and safety of newer-generation sulfonylureas, with focus on glimepiride.

Methods: A detailed literature search was conducted using relevant terms in PubMed to identify articles published.

Results: The newer sulfonylureas, including glimepiride, have been widely used for the treatment of type 2 diabetes mellitus (T2DM) because of their proven efficacy, safety, and cost-effectiveness. However, there have been some concerns raised regarding the cardiovascular safety profile of glimepiride. The CAROLINA trial demonstrated that linagliptin was noninferior to glimepiride and did not increase the risk of hospitalization for heart failure (HF). The results of the CAROLINA trial did not find increased cardiovascular disease risk when sulfonylureas, specifically glimepiride, were used as second-line therapy added to metformin. Indirect comparison between the CAROLINA and CARMELINA trials confirmed glimepiride's cardiovascular safety in patients with T2DM. The GRADE trial results showed that the hazard ratio (HR) for cardiovascular event (major adverse cardiovascular events, hospitalization for HF, or an aggregate outcome of any cardiovascular event) was 1.1 (95% CI, 0.9–1.4) in the glimepiride group compared with the combined results of glargine, liraglutide, and sitagliptin groups. A recent study by He et al. (2022) in T2DM patients with chronic HF found that long-term continuous glimepiride usage is linked with improved cardiovascular mortality (adjusted HR, 0.34; 95% CI, 0.24–0.48; P < 0.001), fewer emergency room visits, and hospitalizations for HF (adjusted HR, 0.42; 95% CI, 0.36–0.50; P < 0.001), as well as fewer hospitalizations for acute myocardial infarction or stroke (adjusted HR, 0.53; 95% CI, 0.38–0.73; P < 0.001).

Conclusion: Overall, the available evidence confirms the cardiovascular safety profile of glimepiride. Additionally, its proven efficacy profile will continue to support the use of glimepiride in patients with T2DM.

  32. Association between Dietary Composition and Glycemic Variability using Continuous Glucose Monitoring Device in Subjects with Type 2 Diabetes Mellitus Top

Aditi Deshmane*, Arti Muley

*Symbiosis Institute of Health Science, Symbiosis International University, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: We performed an exploratory analysis of the dietary composition of subjects with type 2 diabetes mellitus (T2DM) to understand the association of macronutrients with glycemic variability (GV) metrics using a continuous glucose monitoring (CGM) device.

Methods: Baseline data of 50 T2DM individuals enrolled in an interventional clinical trial (age 20–50 years, glycated hemoglobin (HbA1c) up to 8%, and on metformin only) were explored. A detailed 24-h dietary recall was calculated for the macronutrient composition and analyzed to understand the interaction with GV metrics such as average blood sugar, estimated HbA1c, and time in range (TIR) using FreeStyle Libre Pro (Abbott), a 14-day CGM device.

Results: There were 33 males (66%) and 17 females (34%). The mean calorie consumption was 1877 ± 243 Kcal/day, with 59.24% of total calories from carbohydrates (CHO), 10.89% of total calories from proteins, and 29.87% of total calories from fats. Independent t-test showed that participants with adequate CHO intake (55%–60% of total calories) had significantly better average blood sugar (142.0 ± 24.07 g/dl and P = 0.03) and estimated HbA1c (6.60% ± 0.71% and P = 0.01) than those with high CHO intake, i.e., >60% of the total calories (155.05 ± 13.44 g/dl and 7.06% ± 0.46%, respectively). Similarly, TIR was significantly better (P = 0.00) among those consuming adequate protein (12-15%) with TIR – 68.27% ± 5.15% and TAR – 23.09% ± 10.85% as compared to low protein intake (≤10%) with TIR – 61.03% ± 5.19% and TAR – 32.92% ± 10.38%. A negative correlation was observed between CHO intake and TIR (r = −0.482 and P = 0.00). Similarly, simple linear regression revealed that when CHO intake increases, the TIR decreases; R2 = 0.33, F = 7.72, P = 0.000.

Conclusion: Our results suggest that lowering CHO while increasing the protein in diet will help reduce GV and its complications in individuals with T2DM. Further in-depth studies will aid in confirming these findings and build a piece of robust evidence.

  33. Time Spent in Glycemic Control after Initiating Treatment with Oral Semaglutide versus Empagliflozin: An Exploratory Analysis of the PIONEER 2 Trial Top

Kalyani Khade*, Julio Rosenstock, Bertrand Cariou, Erik Christiansen, Christin L. Hertz, Eduard Montanya, Morten Abildlund Nielsen, Filip K. Knop

*Novo Nordisk, Bengaluru, Karnataka, India

E-mail: [email protected]

Introduction: A standard objective in the management of type 2 diabetes (T2D) is the achievement and maintenance of glycated hemoglobin (HbA1c) targets, but the duration of time that patients spend within glycemic control targets has not been previously reported for oral semaglutide. In this exploratory analysis, the duration of time that patients were in glycemic control (HbA1c <7.0% and <6.5%) during the 52-week PIONEER 2 trial was assessed.

Methods: Patients with uncontrolled T2D (n = 822; HbA1c 7.0%–10.5%) were randomized to oral semaglutide 14 mg once daily or empagliflozin 25 mg once daily. Both drugs underwent dose escalation, with oral sema starting at 3 mg, increasing to 7 mg after 4 weeks, and 14 mg after 8 weeks. Empagliflozin was initiated at 10 mg and escalated to 25 mg after 8 weeks. The outcomes were evaluated using the on-treatment without rescue medication observation period in all randomized patients.

Results: Baseline characteristics were similar between treatment arms. The mean baseline HbA1c for both arms was 8.1%. A greater proportion of patients receiving oral sema versus empa achieved HbA1c <7.0% at some point during the study (78% vs. 60%), and for the following lengths of time that HbA1c remained <7%: ≥14 weeks (65% vs. 48%), ≥26 weeks (56% vs. 38%), and ≥38 weeks (46% vs. 28%). During treatment, the overall mean duration of time spent at HbA1c <7.0% and <6.5% was 27 weeks and 16 weeks, respectively, for oral sema, and 19 weeks and 7 weeks for empa. Based on the Trial Product Estimand, the odds of patients achieving HbA1c <7.0% at both weeks 26 and 52 were significantly greater with oral sema versus empa.

Conclusion: Despite an 8-week dose escalation schedule and a mean baseline HbA1c of 8.1%, nearly half of the patients receiving oral sema achieved glycemic control (HbA1c <7.0%) for more than 70% of the 52-week treatment duration. These data suggest that patients spend more time in glycemic control during treatment with oral sema versus empa.

  34. Greater Time Spent in Glycemic Control with Oral Semaglutide versus Oral Comparators Top

Shreyas Deshmukh*, Filip K. Knop, Bertrand Cariou, Johanna Eliasson, Guillaume Frappin, Margit S. Kaltoft, Eduard Montanya, Julio Rosenstock

*Novo Nordisk, Bengaluru, Karnataka, India

E-mail: [email protected]

Introduction: This exploratory analysis aimed to determine time spent with glycated hemoglobin (HbA1c) <7.0% and the likelihood of maintaining this glycemic target by patients with type 2 diabetes in PIONEER efficacy trials of ≥52 weeks' duration.

Methods: Patients in the PIONEER 2, 3, 4, and 7 trials were randomized to oral semaglutide versus active comparators (empagliflozin 25 mg, sitagliptin 100 mg, and liraglutide 1.8 mg once daily). Outcomes were evaluated for oral semaglutide versus active comparators using on-treatment without rescue medication data for all randomized patients. A binary endpoint of achieving HbA1c <7.0% at both weeks 26 and 52 of each trial (week 78 for PIONEER 3) was analyzed using a logistic regression model, with treatment, region, and strata as categorical fixed effects and baseline value as a covariate.

Results: The mean baseline HbA1c ranged from 8.0% to 8.3%. The median duration of time spent with HbA1c <7.0% was greater with oral semaglutide versus oral comparators. The mean and median duration of time spent in glycemic control with oral semaglutide was like that seen with liraglutide. Greater proportions of patients had HbA1c <7.0% for ≥38 weeks with oral semaglutide than with empagliflozin (46% vs. 28%, respectively) and sitagliptin (PIONEER 3: 45% vs. 28%, respectively; PIONEER 7: 27% vs. 14%, respectively) but not liraglutide (46% vs. 48%, respectively). The odds of patients achieving HbA1c <7.0% at both weeks 26 and 52 were significantly greater with oral semaglutide versus comparators.

Conclusion: In PIONEER trials of ≥52 weeks, oral semaglutide resulted in greater time spent at glycemic target and a greater likelihood of maintaining glycemic control versus oral comparators. Patients receiving oral semaglutide spent a similar time in glycemic control versus liraglutide.

  35. Investigating the Effect of Oral Glutathione Supplementation to Improve the Standards of Personalized Type 2 Diabetes Care Top

Arjun Kolappurath Madathil*, Saroj Ghaskadbi, Saurabh Kalamkar, Pranay Goel

*Indian Institute of Science Education and Research, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: Hyperglycemia-induced oxidative stress gives rise to complications in type 2 diabetes (T2D). T2D individuals reportedly exhibit reduced levels of glutathione (GSH), an endogenous antioxidant in cells crucial in determining their redox status. Replenishing GSH could help enhance systemic redox status in T2D.

Methods: A six-month-long pragmatic prospective clinical trial (CTRI/2018/01/011257) was conducted to investigate the effect of oral GSH supplementation on erythrocytic GSH stores and glucose homeostasis in T2D patients undergoing antidiabetic treatment. We performed an inter-individual analysis with the framework of linear mixed-effects (LME) models to understand the dynamics of longitudinal biochemical responses and their variation between individuals for elucidating effective personalized interventions with GSH.

Results: LME model trajectories described how biochemical parameters in T2D patients progress over a 6-month period. We estimated significant improvements in erythrocytic GSH at a rate of 108 μM per month and a reduction in 8-OHdG at 18.5 ng/μg DNA per month in T2D patients. GSH replenished slower in elder patients than in younger ones. 8-OHdG reduced more rapidly in the elder (24 ng/μg DNA per month) than in younger (12 ng/μg DNA per month) individuals. A substantial reduction in HbA1c (0.1% per month) and increased fasting insulin (0.6 μU/mL per month) was observed in elder patients.

Conclusion: Long-term GSH supplementation improves body stores of GSH and offers protection from oxidative damage. It also helps maintain lower HbA1c and improves fasting insulin in elderly T2D patients. LME model estimates characterize the variability in the inter-individual biochemical response in particular, determined by the age group of T2D patients, and help in evaluating the progress of treatment and glucose control targets. These results and model predictions assist clinicians in personalizing treatment goals for using oral GSH supplementation as an adjunct therapy in T2D.

  36. Publication Rate of Industry-sponsored Type 2 Diabetes Mellitus Clinical Trials Registered on ClinicalTrials.gov Top

Pravin Bolshete*, Ruchika Thale, Madhura Donde, Rupika Pawar, Snehal Khanolkar

*Sqarona Medical Communications LLP, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: Clinical trials play a vital role in evidence-based medicine. Registration of these trials in a publicly accessible database is important; however, nonreporting of trial results may affect the validity of the literature and may negatively affect patient care. This study evaluated the publication rate of industry-sponsored type 2 diabetes mellitus (T2DM) clinical trials registered on ClinicalTrials.gov.

Methods: This was a cross-sectional study. ClinicalTrials.gov was searched on February 1, 2023, to identify all the registered interventional phase 2 and 3 clinical trials involving adult patients with T2DM with a primary study completion/termination date between January 1, 2000, and December 31, 2020. Publication of results in peer-reviewed journals was noted by PubMed or by hand search. Data presented at conferences, published in proceedings, and posting of results on ClinicalTrials.Gov were not considered publications.

Results: A total of 693 trials were included (completed, n = 633; results posted, n = 453; >500 participants, n = 193; phase 3, n = 464; randomized, n = 644). Of the 693, 408 (58.9%) trials were published. Of the completed trials, 61.9%, and of terminated trials, 26.7% were published ( odds ratio [OR]: 2.32, confidence interval [CI]: 1.52, 3.55); among phase 3 and 2 trials, 69.0% and 38.5% (OR: 0.56, CI: 0.47, 0.66), respectively, were published, whereas among trials with >500 and <500 participants, 80.3% and 50.6% (OR: 0.63, CI: 0.56, 0.70) were published. Among trials with and without results, 71.1% and 35.8% (OR: 1.98, CI: 1.66, 2.37), and among randomized and nonrandomized, 60.4% and 38.8% (OR: 1.56, CI: 1.09, 2.23), respectively, were published.

Conclusion: Overall results demonstrate that over 60% of the industry-sponsored phase 2 and 3 clinical trials were published. Completed trials, phase of the trials, higher sample size, trial results on the registry, and randomization were associated with publication.

  37. Real-world Effectiveness of Digital Therapeutics in Improving Sleep Quality in People with Diabetes and Hypertension Top

Manthan Mehta*, Ritika Verma, Archana Munje, Sheethal Brahmesh, Abhijit Aklujkar, Utsav Sahu, Karunesh Kumar, Suhas Erande, Vineet Nair, Arbinder Kumar Singal

*Fitterfly Health Tech Pvt Ltd, Navi Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: Sufficient and healthy sleep has an inverse association with cardiovascular disease (CVD) and its risk factors. Hypertension and diabetes are major modifiable risk factors for CVD. The American Heart Association has added sleep health to Life's Essential 8 score as a measure of cardiovascular health. The study aims at the real-world analysis of changes in sleep quality among people with type 2 diabetes and hypertension after participation in the Fitterfly diabetes digital therapeutics program.

Methods: De-identified pre- and postprogram data of 90 participants with diabetes and hypertension (mean age-54.9 ± 10.8; females-37.7%) on the Fitterfly diabetes program were analyzed. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was assessed at baseline and intervention was provided on the digital therapeutics platform with the reassessment of PSQI after 90 days. The 90-day program provided access to mobile application-based health coaching along with virtual access to experts involving nutritionists, psychologists, and physiotherapists. Psychologists provided care based on techniques such as cognitive and intensive behavior, positive self-talk, box breathing, and gadget usage before bedtime to improve sleep quality. Results are expressed as median (range).

Results: At baseline, 55.50% of members had a PSQI score of ≥5, indicating a poor sleep quality. Sleep medication usage was high in females (female – 17.64%; male – 1.78% [P = 0.01]). After the program, the median global PSQI score reduced by 70.00% from a baseline of 5 (0–16) to 1.5 (0–10). The PSQI subscale scores for sleep duration, disruption, latency, daytime sleepiness, and medication were also reduced significantly (P < 0.05). Postprogram, the sleep medication usage reduced to 2.9% in females.

Conclusion: Poor sleep quality was noted in 55% of people with diabetes and hypertension. The study demonstrated the significant reduction in global PSQI and its subcomponents after personalized digital therapeutics interventions of the Fitterfly Diabetes program.

  38. Improvement in Emotional and Mental Well-being in People with Diabetes and Hypertension after Participation in Digital Therapeutics Program Top

Manthan Mehta*, Neha Verma, Nishul Gupta, Archana Munje, Tejal Lathia, Snehal Tanna, Lily Rodrigues, Vivek Baliga, Shilpa Joshi, Arbinder Kumar Singal

*Fitterfly Health Tech Pvt Ltd, Navi Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: Diabetes-related distress is associated with the predicted 10-year risk for coronary heart disease. Behavioral changes are critical to implement lifestyle interventions for diabetes and cardiovascular disease risk management. We analyzed the effectiveness of digital therapeutics-driven psychotherapy sessions to manage diabetes distress and increase motivation in people with diabetes and hypertension.

Methods: De-identified pre- and postprogram data from 112 Fitterfly Diabetes Program members with self-reported high cardiovascular risk were used (mean age: 55.3 ± 10.8; female: 41.07%). The Diabetes Distress Scale (DDS) questionnaire assessed emotional burden, physician-related, regimen-related, interpersonal, and total distress. The Motivation and Attitudes Toward Changing Health (MATCH) questionnaire evaluated willingness, ableness, and worthwhileness to cope with required lifestyle alterations. Psychologists delivered personalized psychotherapies based on dialectical behavior, cognitive and intensive behavior, Gestalt therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing. Program also offered nutrition and exercise regimen consultations. Results are expressed as median (range). Statistical analyses used Wilcoxon and Mann–Whitney U-tests.

Results: At baseline, 15.17% exhibited high diabetes distress and 21.42% showed moderate distress scores. Except for physician-related distress, members under 60 years had higher total DDS and subcomponent scores (P < 0.05). Preprogram ableness scores were higher in members above 60 years (12 [6–15]) compared to below 60 years of age [(10 (5–15)] (P = 0.008). Postprogram, the median overall distress score reduced by 25% (P < 0.0001). A substantial reduction in median scores for DDS subscales including emotional burden, physician-related, regimen-related, and interpersonal distress was also observed (P < 0.0001). After the program, the median MATCH score showed a significant improvement by 16.7% (P < 0.0001). Furthermore, the MATCH subcomponent scores for willingness, ableness, and worthwhileness significantly improved (P < 0.01).

Conclusion: Digital therapeutics programs can help in reduction of diabetes distress and improvement in motivation for behavior change in people with diabetes and hypertension. Such programs can help in improved health outcomes and better management of their conditions.

  39. Effect of Virtual Personalized Exercise Prescription: Substantial Improvement in Physical Fitness in People with Diabetes and Hypertension Top

b>Manthan Mehta*, Madhura Bhagat, Anuradha Mandlekar, Archana Munje, Chitra Selvan, Deepak Burkul, Vaishali Lokhande, Medha Oak, M. S. Vivek, Arbinder Kumar Singal

*Fitterfly Health Tech Pvt Ltd, Akshar BlueChip Corporate Park, Navi Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: Regular exercise positively influences the established risk factors for cardiovascular disease. Unsupervised home exercise suffers from low adherence, risk of injury, and a higher participant dropout rate. We determined the effect of digital delivery and supervision of personalized exercise interventions on fitness scores in people with diabetes and high cardiovascular risk as a part of the Fitterfly Diabetes program.

Methods: De-identified pre- and postprogram data of 50 participants (mean age-49.7 ± 9.5; female-44%) with high cardiovascular risk on the Fitterfly Diabetes 90-day program were analyzed for fitness scores. Various physical fitness tests recommended by the American Diabetes Association and American College of Sports Medicine were used to determine upper body strength, lower body strength, core strength, and flexibility. The summation of the individual test scores was used as a final readout of the total fitness score. For cardiac fitness, functional exercise capacity assessment, a modified 6-min walk test (6MWT) was used. Personalized exercise prescriptions for strength improvement considering pain on performance of fitness tests were provided and demonstrated by physiotherapists. The exercise regimens were monitored throughout the program. The program offered personalized support for nutrition and psychological well-being. Results are expressed in median (range).

Results: At baseline, 76% had poor total fitness scores (≤20). Postprogram, we recorded a significant rise of 42.85% in median fitness scores (preprogram – 14 [−3, 28} and postprogram – 20 [−3, 34}; P < 0.0001). Substantial improvement of 12.30% was noted in modified 6MWT (p20 indicating “good” level of fitness in 48.00% of members at the end of the program was recorded. All individual fitness test scores also improved (P < 0.01).

Conclusion: Baseline poor fitness scores were evident in 76% of participants. The study demonstrated the effectiveness of digital fitness assessments and personalized exercise regimens to improve physical fitness and cardiorespiratory fitness in people with diabetes and hypertension.

  40. Electrochemical Skin Conductance as a Risk Predictor in Diabetes Top

S. R. Lalwani*, Kumar Abhisheka, Chandan Tiwari

*Army Hospital Research and Referral, New Delhi, India

E-mail: [email protected]

Introduction: The rationale for this study was to determine the role of diabetic neuropathy as assessed by electrochemical skin conductance (ESC) of feet in cardiovascular risk assessment.

Methods: Patients were recruited from Endocrinology OPD at a tertiary care government hospital in North India. We looked for the presence of macrovascular complication (coronary artery disease and/or cerebrovascular accident and/or peripheral artery disease in 135 serial patients reporting for management of diabetes. All the patients underwent assessment of glycemic control and the presence of microvascular or macrovascular complication. Sudoscan (Impeto Medical, Paris), a device for precise evaluation of sudomotor function, was used to estimate the ESC values of hands and feet. A value of <60 μS was considered to be having neuropathy. For assessment of risk, ESC of feet was used.

Results: The mean age of patients in our study was 60.20 ± 11.09 years with a mean duration of diabetes of 10.85 ± 7.65 years. There were 51 males in the study (37.8%). Twenty-seven patients had macrovascular complication (24 CAD, 2 PAD, and 1 CVA). 57 (42.2%) patients had diabetic nephropathy, 29 (21.5%) patients had diabetic retinopathy and 61 (45.2%) had diabetic nephropathy. Out of 57 patients with diabetic neuropathy 13 had macrovascular complication which was not significantly different from 14 patients out of 78 who had no neuropathy (Fisher Exact test P = 0.52). Similarly, diabetic retinopathy did not appear to be a risk predictor for cardiovascular disease but diabetic nephropathy emerged as the only microvascular complication which could predict cardiovascular risk (Fisher Exact test P = 0.05). On multivariate analysis age, gender, low-density lipoprotein cholesterol, hypertension, and duration of diabetes emerged as the only useful predictor of the cardiovascular risk in our patients of diabetes. Urinary albumin creatinine ratio did not contribute to this model. As none of our patients were smokers

  41. Assessment of Metabolic Profile and Serum Inflammatory Markers with Vitamin D Status in Type 2 Diabetes Mellitus: A Comparative Study in a Tertiary Care Hospital, Mysore, Karnataka, South India Top

K. M. Srinath*, P. V. Salimath, H. Basavanagowdappa

*JSS Medical College and Hospital, Mysuru, Karnataka, India

E-mail: [email protected]

Introduction: Evidence is growing on the extra skeleton activity of Vitamin D including the role in the development of type 2 diabetes mellitus and may alter the processes such as insulin secretion, insulin resistance, and systematic inflammation. This study aims to assess whether Vitamin D insufficiency and deficiency status influence the glucose and lipid profiles among diabetes mellitus.

Methods: A cross-sectional comparative study was carried out among 84 diabetes mellitus and 84 control subjects in a tertiary care hospital, Mysore. Serum samples were collected and estimated for Vitamin D status and its influence on metabolic (glucose profile, lipid profile, and insulin levels) parameters and serum inflammatory markers (interleukin-6 [IL-6}, IL-1, and tumor necrosis factor [TNF]-alpha) were assessed.

Results: Vitamin D deficiency, i.e., <20 ng/dl, was observed among 58 (69.04%) and 64 (80.9%) of the control and diabetic groups, respectively. Vitamin D insufficiency i.e., 21–30 ng/dl was observed in 14 (16.6%) controls and 13 (15.4%) diabetics. A Vitamin D level of >30 ng/dl was seen in 12.7% and 3.5% of controls and diabetics respectively. All the metabolic parameters such as glucose profile, lipid profile, insulin levels, and HOMA-IR were in the higher range in the Vitamin D deficient group of both controls and diabetes mellitus groups. Serum inflammatory markers IL-1, IL-6, and TNF-alpha were also higher in both the groups.

Conclusion: Vitamin D insufficiency and deficiency have been a significant public Health problem not only among diabetes mellitus but also among the general populations. With the coexisting other lifestyle changes that alter the metabolism, vitamin D is likely to influence the glucose parameters, lipid parameters, and systemic inflammation. Hence, screening every individual for Vitamin D deficiency and correcting with Vitamin D Supplements may influence the glucose and lipid metabolism and prevent insulin resistance.

  42. Correlation of Clinical Profile and Glucometrics Using Continuous Glucose Monitoring in Patients with Diabetes in a Tertiary Care Hospital Top

Abhijit Chavan*, Jitendra Ingole

*Smt. Kashibai Navale Medical College, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: Correlation of clinical profile and glucometrics using continuous glucose monitoring (CGM) in patients with diabetes

Methods: After IEC permission, a single-center prospective study of patients with diabetes mellitus willing to participate in a CGM study was started at tertiary health care. The patients were monitored and received treatment while the CGM was operating (8–14 days). Data were summarized using medians and interquartile ranges when the variables were continuous and frequencies and percentages for categorical variables. To assess differences in the outcome variables, time in range, GV (% Coe. of Variation) with linear regression which estimates mean differences across categories (Yes/No) and gives 95% confidence interval (CI) for P value for the difference. When primary outcome variables were dichotomized, logistic regression was used to estimate odds ratios and corresponding 95% CIs. A variable was considered significantly different if the P value was <0.05. Exploratory analysis was performed for continuous data using either a histogram or a box plot across the presence and absence of comorbid conditions. All statistical analysis was performed using R.

Results: Patients with tingling and numbness had low TIR (P = 0.009) and high GV (P value 0.001), similarly for diminished vision TIR (0.01), GV (0.009) and bladder urgency TIR (0.012), GV (0.001), respectively. Patients with high GV had higher rates of complications such as diabetic retinopathy (0.05), diabetic neuropathy (0.01), and diabetic foot ulcer (0.04), respectively.

Conclusion: Patients with tingling and numbness, diminished vision, and bladder urgency had less TIR and high glycemic variability. Patients with diabetes with higher GV had more complications such as diabetic retinopathy, diabetic neuropathy, and diabetic foot. Graphical patterns of blood glucose levels enable clinicians to precisely tailor therapy of anti-diabetic medications.

  43. Fenofibrate Therapy and Diabetic Retinopathy: A Pilot Analysis Top

Amruta Kulkarni*, Mansi Jadhav, Vandana Zaware, Savita Bhat Shalbha Tiwari, A. G. Unnikrishnan

*Chellaram Diabetes Institute, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: It is well known that fenofibrate, a PPARx agonist and an anti- hypertriglyceridemic agent, have a beneficial effect in diabetic retinopathy (DR). We aimed to evaluate the progression of DR in patients on fenofibrate.

Methods: We retrospectively analyzed records of our institution for people with DR and who were taking fenifibrate since 2019 and we also reviewed their clinical records of the follow-up visits till 2022 to know the status of DR.

Results: We found that out of 7989 patients diagnosed with DR, only 31 patients were on fenofibrate. Among 31 patients, 9 patients had fundus photo and scan available for two follow-up visits done 2 years apart. The mean age was 54 years (range: 28–78), duration of diabetes was 16.7 years and 44.44% were women. The fundus photo revealed mild nonproliferative DR in 1, moderate nonproliferative DR in 2, and severe non-proliferative DR in three subjects. Proliferative DR and diabetic macular edema were present in three cases each. Over 2 years of follow-up, the subjects did not show the progression of retinopathy.

Conclusion: There is a very small number of DR patients (0.38%) who were taking fenofibrate. Follow-up fundus assessment showed that fenofibrate-taking subjects did not experience any worsening of DR. Fenofibrate seems to have a beneficial effect on DR and could be preferred over other anti-hypertriglyceridemic agents in patients with risk of DR.

[TAG:2]44. Efficacy and Safety of Triple Fixed-Dose Combination of Dapagliflozin, Sitagliptin, and Extended Release Metformin Tablets in Indian Patients with Type 2 Diabetes Mellitus Poorly Controlled with Metformin: Phase 3 Randomized, Open-Label, Three-Arm Study in Comparison with Dual Combinations[/TAG:2]

Rakesh Sahay, Richa Giri, Jayashree Shembalkar, Sandeep Gupta, Brij Mohan, Prakash Kurmi, S. Ravindra Kumar, Vinayak Sawardekar, Ashutosh Mishra, L. Sreenivasa Murthy, Vivek Arya, Abhijit Sonawane, Pravin Soni, Sandip Gofne, Shital Karnawat, Mandodari Rajurkar*, Piyush Patel, Lalit Lakhwani, Suyog Mehta, Sadhna Joglekar

*Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India

E-mail: [email protected]

Introduction: Type 2 diabetes mellitus (T2DM), characterized by progressive beta-cell failure, requires a complex treatment regimen as the disease progresses. A triple fixed-dose combination (FDC) regimen is suggested to improve treatment adherence reducing pill burden and tight glycemic control, delaying the need for insulin.

To assess the efficacy and safety of triple FDC of dapagliflozin (DAPA)+sitagliptin (SITA)+metformin (MET) extended-release (ER) compared to dual combinations in patients with T2DM poorly controlled with metformin.

Methods: This phase 3, randomized, open-label, active-controlled study included patients with glycated hemoglobin (HbA1c) ≥8% and ≤11% and on a stable total dose of metformin (1500–2000 mg/day). Of 471 patients screened, 415 were randomized to FDC of DAPA+SITA+MET-ER (10 + 100 + 1000 mg/day) (n = 137), or coadministration of SITA+MET-sustained release (SR) (100 + 1000 mg/day) (n = 139) or FDC of DAPA+MET ER (10 + 1000 mg/day) (n = 139), along with metformin 500–1000 mg/day. The primary efficacy endpoint was the mean change in HbA1c from baseline at week 16.

Results: Mean baseline HbA1c was ~9%. At week 16, mean change in HbA1c was significantly greater with DAPA+SITA+MET-ER (−1.75%) compared to SITA+MET-SR (−1.28%; difference 0.47%, P < 0.001) and DAPA + MET-ER (−1.32%; difference −0.43%, P < 0.001). Similarly, at week 12, reduction in HbA1c was significantly greater with DAPA+SITA+MET-ER compared to SITA + MET-SR (P = 0.0006) and DAPA + MET ER (P = 0.0276). At week 16, DAPA+SITA+MET-ER showed a significantly greater reduction in postprandial blood glucose compared with DAPA + MET-ER (P = 0.0394) and in fasting blood glucose in comparison with SITA + MET-SR (P = 0.0226). The proportion of patients achieving HbA1c <7.0% at week 16 was significantly more with DAPA+SITAMET-ER (38.5%) versus SITA+MET-SR (12.8%, P < 0.001) and DAPA+MET-ER (21.3%, P = 0.0023). No patient required rescue medication. Study medications were well-tolerated without any severe/serious adverse events.

Conclusion: Overall, the FDC of Dapa + Sita + Met-ER was significantly superior compared to Sita+Met-SR combipack tablets and FDC of Dapa+Met-ER in terms of HbA1c reduction at week 12 and week 16 without any safety concerns.

[TAG:2]45. Efficacy and Safety of Fixed-dose Combination of Sitagliptin, Metformin and Glimepiride Tablets in Indian Patients with Type 2 Diabetes Mellitus in Comparison With Coadministration of Metformin And Glimepiride: Interim Analysis of Phase 3, Randomized, Double-Blind Study[/TAG:2]

Hemant Gupta, Rakesh Sahay, Vikas Agarwal, Sandesh Patil, A. Gopal Rao, Sandip Gofne, Ambana Gowda, Abhay Sahoo, Ramesh Duraisamy, Pradeep Rai, Raisa Shaikh, Mandodari Rajurkar*, Piyush Patel, Lalit Lakhwani, Suyog Mehta, Sadhna Joglekar

*Sun Pharma Laboratories Limited, Maharashtra, India

E-mail: [email protected]

Introduction: Type 2 diabetes mellitus (T2DM), led by progressive beta-cell failure, necessitates the administration of multiple tablets or injections to achieve good glycemic control as the disease progresses.

To assess the efficacy and safety of triple-drug fixed-dose combination (FDC) in comparison to two coadministered drugs in T2DM.

Methods: This is an ongoing phase III, randomized, double-blind, double-dummy, active-controlled study (16 weeks) followed by an open-label, single-arm study (12 weeks), which included adult patients with glycated hemoglobin (HbA1c) ≥8 and ≤11% and on the stable total dose of glimepiride 4 mg/day and metformin ≥1500 mg/day. Eligible patients were randomized to either FDC of sitagliptin+metformin+glimepiride tablets (50/1000/1 mg) twice daily (BID) (test group) OR coadministration of metformin 500 mg (2 tablets BID) and glimepiride 2 mg tablets BID (comparator group). Of the total 392 patients, 127 patients were randomized initially. We present the interim analysis of these 127 patients who had completed 16 weeks of double-blind treatment. At week-16, the study was considered completed for patients in the comparator group, and dose up-titration was done in the test group if HbA1c ≥8%.

Results: Of 161 patients screened, 127 were randomized (test [n = 60]; comparator [n = 67]). Baseline HbA1c was ~9%. Both treatments demonstrated a significant reduction in HbA1c at week 12 and week 16 (P < 0.001 each). HbA1c reduction was significantly more in the test group at week-16 (test vs. comparator: −1.92% ± 1.03% vs. −1.38% ± 1.20%, P = 0.0080). Although a significant reduction in fasting and postprandial blood glucose from baseline to week 12 and week 16 was noted within the groups (P < 0.001 each), data were comparable between the groups. Overall 29 treatment emergent adverse events (AEs) were reported (15 events [test group] and 14 events [comparator group]). No patient required hypoglycemia management, and the study medications were well-tolerated without any severe/serious AEs.

Conclusion: Triple FDC of sitagliptin+metformin+glimepiride was significantly superior to coadministered metformin and glimepiride in reducing HbA1c at week 16. Study medications were safe and well-tolerated.

  46. In vitro and In vivo Evaluation of Coriander Seeds (Coriandrum sativum l.): for Antihyperglycemic, Antioxidant, and Hypolipidemic Effects Top

C. U. Rajeswari, B. Andallu*

*Sri Sathya Sai Institute of Higher Learning, Anantapur, Andhra Pradesh, India

E-mail: [email protected]

Introduction: To assess coriander seeds (Pimpinella anisum L.), commonly known as “Dhania,” used as a spice, for antihyperglycemic, antioxidant, and hypolipidemic activities in model systems (in vitro) and in type 2 diabetes mellitus (T2DM) patients (in vivo).

Methods: Antihyperglycemic, antioxidant, and hypolipidemic activities of coriander seed extracts were tested in vitro using suitable standard methods. The seeds were evaluated for these effects in vivo with ethical clearance by administrating the seeds (5 g/day) to selected type 2 diabetes patients for 60 days, followed by the estimation of biochemical parameters, namely fasting glucose, lipid profile, lipid peroxidation, and protein oxidation (oxidative stress markers), enzymatic and nonenzymatic antioxidants initially and at the end of 60 days of the experimental period and compared with that of a control group, treated with the antidiabetic drug. The data were statistically analyzed using paired t-tests.

Results: Methanolic extract and ethyl acetate fraction of coriander seeds exhibited significant radical scavenging activities and had shown in vitro antihyperglycemic and hypolipidemic effects by inhibiting the activities of carbohydrate hydrolyzing enzymes (α-amylase and α-glucosidase), lipid hydrolyzing enzyme (pancreatic lipase), respectively. In vivo assessment in T2DM patients revealed coriander seeds to be anti-hyperglycemic, hypolipidemic, and antioxidative, as evidenced by significantly decreased blood glucose, lipid profile, lipid peroxidation, protein oxidation, significantly improved high-density lipoprotein cholesterol, enzymatic and nonenzymatic antioxidants in the experimental group while most of these effects were not observed in the control group treated with the antidiabetic drug.

Conclusion: This investigation proved coriander seeds to be antihyperglycemic, hypolipidemic, and antioxidative by virtue of phytochemicals, and hence, protective against stress-induced diseases such as diabetes.

  47. Continuous Glucose Monitoring of Patients with Diabetes in an Intensive Care Unit: A Single-center Experience Top

Sudeep Jain*, Prashant Bhalekar, Nikita Sarkar, Ashutosh Pakale, Pooja Kamthe, Vedavati Purandare, Shalbha Tiwari, A. G. Unnikrishnan

*Chellaram Diabetes Institute, Pune, Maharashtra, India

E-mail: [email protected]

Introduction: Continuous glucose monitoring (CGM) is becoming an important tool in diabetes management. CGM gives estimates of glucose variability and also detects hypoglycemic events. To our knowledge, there is no study of CGM use in the hospital intensive care unit (ICU) from India. We undertook this analysis to assess CGM in the management of ICU patients with diabetes.

Methods: We retrospectively collected the data from August 2021 to February 2023 of ICU patients with diabetes who were on CGM (FreeStyle Libre). Demographic, clinical, laboratory, glucometer readings and CGM data were reviewed and analyzed; data were presented as median (range).

Results: We analyzed data of 30 patients, out of which 90% had type 2 diabetes. The median age was 67.5 years and the male:female ratio was 1:1. The most common reasons for ICU admission were infection (10) and cardiovascular events (12). The percentage coefficient of variation value was 34 (11–54); using a cutoff of <36 as acceptable, 14/30 (47%) had glycemic variability. The percentage TIR, TBR, and TAR values were 59 (11–87), 3 (0–49), and 31 (0–85), respectively. The average glucose (mg/dl) was 161 (84–312). Totally, 29 episodes of hypoglycemia were diagnosed, all confirmed by capillary glucose test. Fourteen patients had hypoglycemia, of which 8 had nocturnal hypoglycemia.

Conclusion: The use of CGM in ICU was associated with an acceptable blood glucose control. CGM helped to diagnose hypoglycemia, particularly nocturnal, in a significant proportion of patients. A controlled study comparing CGM versus no CGM use in ICU will further confirm if CGM reduces the incidence of hypoglycemia and improves glucose control in ICU.

  48. Revisiting Various Dimensions of Nonsurgical Offloading of Diabetic Foot – Case Series from a Tertiary Care Hospital in North Karnataka Top

Anoosha Bhandarkar*, Manjunath Ingole, Sughosh Kulkarni

*SDM College of Medical Sciences & Hospital, Dharwad, Karnataka, India

E-mail: [email protected]

Introduction: Offloading, which means to relieve pressure from an ulcerated area or high-risk zones, is the key to preventing or healing plantar neuropathic foot ulcers in diabetes. Though simple to practice, it is the most neglected and undermined procedure in management of diabetic foot. Understanding various techniques of offloading and practicing it in day-to-day management serves to prevent the recurrence of diabetic foot ulcer (DFU) and save the limb at an early stage. We hereby describe five diabetic neuropathic foot cases to elucidate various techniques of non-surgical offloading and their effectiveness in treating diabetic foot conditions.

Methods: Cases were screened and categorized based on the risk stratification system of International Working Group on the Diabetic Foot (IWGDF - 2019). Plantar pressure studies were performed to assess the high-risk areas for DFU. Appropriate offloading modalities were selected and applied viz. callus excision, temporary offloading with felts and foams, metatarsal bars, total contact cast, Charcot restraint orthotic walker, offloading and accommodative custom-made footwears. The devices utilized were indigenously designed at our center. The patients were followed up till complete healing of DFUs and further given appropriate maintenance offloading measures to prevent the recurrence of ulceration and other foot related complications.

Results: IWGDF clinical guidelines are a widely accepted and effective tool in risk stratifying the diabetic foot cases for the prevention of foot ulceration. Each offloading modality served to benefit the patients when applied appropriately for the risk category.

Conclusion: Although the efficacy differs, each offloading modality has its own role to play in management of DFU. Offloading is one of the most important interventions for healing foot ulcers and reducing the global burden of diabetic foot disease.

  49. Evaluation of Naturally Derived Nano-biopolymer for the Treatment of Chronic Diabetic Foot Ulcers – Preliminary Case Studies Top

Syed G. Dastager, Sughosh Kulkarni*, Anoosha Bhandarkar

*SDM College of Medical Sciences & Hospital,Dharwad, Karnataka, India

E-mail: [email protected]

Introduction: Wound dressing materials based on polymers have attracted much attention in the management of chronic diabetic foot ulcers (DFU). An ideal wound dressing material should possess low cytotoxicity, maintain moist environment, and promote wound healing. Furthermore, it should be nonadherent, absorbable, cost-effective, and reduce the colonization of bacteria. CSIR-NCL, Pune has developed a technology of producing abundant high yield nano-biopolymer from a natural source having 99% purity with unique micromorphology enabling it to have large surface area, great water holding capacity, high porosity and excellent mechanical strength.

Methodology: After ensuring preliminary animal safety of the nano-biopolymer, we tested it in four different clinical cases of chronic DFU in a tertiary care hospital as a pilot study to investigate the safety and efficacy. The nano-biopolymer gel was first sterilized by autoclaving and then mixed with topical antibiotics and applied in the initial dressings after thorough debridement of infected DFU. As the infection cleared, the nano-biopolymer gel was mixed with collagen granules to enhance the wound closure in subsequent dressings. The dressings were performed following sterile aseptic precautions along with appropriate wound off-loading techniques.

Results: All four cases of DFU were successfully treated showing good granulation tissue formation and secondary wound closure. There were no any local or systemic adverse reactions. It did not get absorbed completely and formed a protective layer over the wound exhibiting good mechanical strength. There was no slippage or leakage of the wound dressing.

Conclusion: The CSIR-NCL Pune Nano-biopolymer is so far found to be safe, easy to use material, cost effective and facilitating wound healing in chronic DFUs. It would retain optimum moisture and create a good micro-environment for wound healing. It would serve as a carrier for bioactive agents like – antibiotics or collagen granules, facilitating their absorption without interfering in their actions.


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