Significant Reduction In HbA1c Research Articles

A Personalized Mobile Health Program for Type 2 Diabetes During the COVID-19 Pandemic: Single-Group Pre–Post Study

BackgroundWith increasing type 2 diabetes prevalence, there is a need for effective programs that support diabetes management and improve type 2 diabetes outcomes. Mobile health (mHealth) interventions have shown promising results. With advances in wearable sensors and improved integration, mHealth programs could become more accessible and personalized.ObjectiveThe study aimed to evaluate the feasibility, acceptability, and effectiveness of a personalized mHealth-anchored intervention program in improving glycemic control and enhancing care experience in diabetes management. The program was coincidentally implemented during the national-level lockdown for COVID-19 in Singapore, allowing for a timely study of the use of mHealth for chronic disease management.MethodsPatients with type 2 diabetes or prediabetes were enrolled from the Singapore Armed Forces and offered a 3-month intervention program in addition to the usual care they received. The program was standardized to include (1) in-person initial consultation with a clinical dietitian; (2) in-person review with a diabetes specialist doctor; (3) 1 continuous glucose monitoring device; (4) access to the mobile app for dietary intake and physical activity tracking, and communication via messaging with the dietitian and doctor; and (5) context-sensitive digital health coaching over the mobile app. Medical support was rendered to the patients on an as-needed basis when they required advice on adjustment of medications. Measurements of weight, height, and glycated hemoglobin A1c (HbA1c) were conducted at 2 in-person visits at the start and end of the program. At the end of the program, patients were asked to complete a short acceptability feedback survey to understand the motivation for joining the program, their satisfaction, and suggestions for improvement.ResultsOver a 4-week recruitment period, 130 individuals were screened, the enrollment target of 30 patients was met, and 21 patients completed the program and were included in the final analyses; 9 patients were lost to follow-up (full data were not available for the final analyses). There were no differences in the baseline characteristics between patients who were included and excluded from the final analyses (age category: P=.23; gender: P=.21; ethnicity: P>.99; diabetes status category: P=.52, medication adjustment category: P=.65; HbA1c category: P=.69; BMI: P>.99). The 21 patients who completed the study rated a mean of 9.0 out of 10 on the Likert scale for both satisfaction questions. For the Yes-No question on benefit of the program, all of the patients selected “Yes.” Mean HbA1c decreased from 7.6% to 7.0% (P=.004). There were no severe hypoglycemia events (glucose level <3.0 mmol/L) reported. Mean weight decreased from 76.8 kg to 73.9 kg (P<.001), a mean decrease of 3.5% from baseline weight. Mean BMI decreased from 27.8 kg/m2 to 26.7 kg/m2 (P<.001).ConclusionsThe personalized mHealth program was feasible, acceptable, and produced significant reductions in HbA1c (P=.004) and body weight (P<.001) in individuals with type 2 diabetes. Such mHealth programs could overcome challenges posed to chronic disease management by COVID-19, including disruptions to in-person health care access.

Effects of Melissa officinalis L. (Lemon Balm) Extract Supplementation on Cardiovascular Risk Factors: A Pooled Analysis of Randomized Controlled Trials

Several clinical trials have investigated the effects of Melissa officinalis (lemon balm) on cardiovascular risk factors, but have yielded conflicting results and had only modest sample sizes. The aim of this pool analysis was to summarize the evidence of the effects of Melissa officinalis supplementation on plasma lipid profiles, body weight, blood pressure and glucose levels. Original randomized controlled trials (RCTs) that assessed the clinical effects of Melissa officinalis consumption in human participants and published before June 2020 were identified by searching online databases, including PubMed, Scopus, Web of Science and Google Scholar databases. The quality of trials was assessed using the Cochrane Risk of Bias Tool. Quantitative data analysis was performed using weighed mean difference (WMD) and 95% confidence interval (CI) as summary statistics. Standard methods for assessing statistical heterogeneity and publication bias were used, respectively. Four trials with 244 participants were included in the final analysis. Pooling of results showed that Melissa officinalis significantly lowered total cholesterol (TC) (WMD, -7.55 mg/dL; 95% CI -14.99, -0.12; P=0.045), low-density lipoprotein cholesterol (LDL-C) (WMD, -11.33 mg/dL; 95% CI -19.46, -3.21; P=0.006), glycated hemoglobin (HbA1c) (WMD, -0.35 %; 95% CI -0.64, -0.07; P=0.01), and Systolic blood pressure (SBP) (WMD, -0.89 mmHg; 95% CI-1.69, -0.09; P=0.03). The use of Melissa officinalis did not appear to significantly alter any other study endpoints. The present findings showed that supplementation with Melissa officinalis extract were associated with a significant reduction in TC, LDL-C, HbA1c, and SBP in humans.

The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study.

IntroductionThe COVID-19 pandemic led to an international health crisis and restrictions. While the phenotype associated with COVID-19 severity in people with diabetes has rapidly been explored, the impact of restrictive measures, including lockdown, and tertiary care disruption on metabolic control and access to healthcare remained unknown. The aim of our study was to provide a comprehensive assessment on the overall management of diabetes during lockdown, including glucose control, weight changes, health care consumption and use of alternative forms of care such as telemedicine services, in a large sample of patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM).MethodsA prioritization of a care self-administered questionnaire was sent at the end of the first COVID-19 lockdown to all patients with diabetes routinely followed by diabetologists from the University Hospital of Nancy (France). This observational cross-sectional single-center study focused on data from patients with diabetes who returned the questionnaire along with medical records. The primary outcome was the change in HbA1c levels between the 6 months preceding and the 6 weeks following the lockdown. Data are expressed as numbers (%) or medians (quartiles). This study is registered with ClinicalTrials.gov (NCT04485351).ResultsWe analyzed data from 870 patients with diabetes: 549 T2DM (63.1%), 520 males (59.8%), age 65.0 (57.0, 72.0), body mass index 28.6 (25.1, 32.9) and diabetes duration 20.0 (10.0, 30.0) years. HbA1c levels pre- and post-lockdown were respectively 7.7% (7.1, 8.4) and 7.4% (6.8, 8.2), translating into a significant reduction of − 0.1% (− 0.6, 0.15) (p < 0.0001). Stratified analyses suggested a consistent significant reduction of HbA1c independently of diabetes type. HbA1c reduction was significantly different according to weight changes: − 0.3% (− 0.8, 0.0), − 0.1% (− 0.5, 0.1) and − 0.1% (− 0.5, 0.3) for patients who lost, had stable or gained weight, respectively (p = 0.0029). Respectively, 423 (49.4%) and 790 (92.3%) patients did not consult their general practitioner and diabetologist. Blood tests were undergone by 379 (44.8%) patients, 673 (78.3%) did refill their prescriptions, and 269 (32.1%) used teleconsultation services.ConclusionsDespite the implementation of a lockdown and disruption in healthcare, no deterioration, rather an improvement, in metabolic control was observed in a large sample of patients with T1DM and T2DM.

SHORT TERM EFFECT OF LAPAROSCOPIC SLEEVE GASTRECTOMY ON TYPE 2 DIABETIC MORBID OBESE PATIENTS

Background: Obesity is a medical condition in which excess body fat has accumulated to extend that it may has an adverse effect on health. Leading to reduction of life expectancy or increasing health problems. Objective: To evaluate the improvement in plasma glucose level and lipid profile in type 2 diabetes mellitus obese patients after Laparoscopic Sleeve Gastrectomy (LSG). Patients and methods: This prospective study was conducted at Surgery Department, Al-Azhar University Hospitals during the period between December 2019 and August 2020. Study included 30 cases of type 2 diabetes mellitus morbidly obese patients (with BMI ≥35 Kg/m²) and all of them had failed in trials of conservative management including dietary control, and they were bulky eater but non sweet eater. Laparoscopic sleeve gastrectomy technique was done for all cases. Results: Our result showed that there was a significant improvement of the HbA1c measured at three and six months post-operatively. Five patients (17%) completely cured from T2DM, while 12 patients (40%) became pre-diabetic, and 13 patients (43%) remained diabetic with great improvement of their previous follow up of HbA1c. Conclusion: LSG was efficient in the remission and/or improvement of symptoms of T2DM and other obesity-related comorbidities, with a significant reduction in serum HbA1c and lipid profile.

High-dose sodium-glucose co-transporter-2 inhibitors are superior in type 2 diabetes: A meta-analysis of randomized clinical trials.

To determine the overall efficacy of high- versus low-dose sodium-glucose co-transporter-2 (SGLT2) inhibitors in patients with type 2 diabetes (T2D). A literature search using MEDLINE, EMBASE and the Cochrane Library was performed from 1 January 2006 to 23 September 2020. Random effects models were used to calculate mean differences (MDs) and pooled relative risk (RR). Prespecified subgroup analyses for each SGLT2 inhibitor, follow-up and controls were performed. Leave-one-out sensitivity and meta-regression analyses were conducted. A total of 51 randomized controlled trials involving 23 989 participants (weighted mean age, 58.9 years; men, 58.8%) were eligible for our meta-analysis. For glycaemic regulation ability, a significant reduction in HbA1c (MD -0.080%, 95% confidence interval [CI] -0.100 to -0.060), fasting plasma glucose (MD -0.227 mmol/L, 95% CI -0.282 to -0.173) and postprandial plasma glucose (MD -0.834 mmol/L, 95% CI -1.268 to -0.400) levels was observed in the high-dose SGLT2 inhibitor group. Treatment with high-dose SGLT2 inhibitors enabled easier achievement of the target (HbA1c <7%) than low-dose SGLT2 inhibitors (RR 1.148, 95% CI 1.104 to 1.193). High-dose SGLT2 inhibitor-based treatment resulted in more efficient regulation of body weight and blood pressure (body weight: MD -0.346 kg, 95% CI -0.437 to -0.254; systolic blood pressure: MD -0.583 mmHg, 95% CI -0.903 to -0.263; diastolic blood pressure: MD -0.352 mmHg, 95% CI -0.563 to -0.142). The results were similar in sensitivity analyses. The overall efficacy of SGLT2 inhibitors, mainly canagliflozin, dapagliflozin and empagliflozin, was found to be dose dependent.

Effectiveness of mHealth management with an implantable glucose sensor and a mobile application among Chinese adults with type 2 diabetes

Introduction This study aimed to evaluate the effectiveness of mHealth management with an implantable glucose sensor and a mobile application among patients with type 2 diabetes mellitus (T2DM) in China. Methods A randomised controlled trial was carried out to compare the effectiveness of usual health management to mHealth management based on a model that consisted of the network platform, an implantable glucose sensor and a mobile app featuring guidance from general practitioners (GPs) over a four-week period. Patients (N=68) with T2DM were randomly divided into an intervention group and a control group. Before the intervention, there was no difference in body mass index (BMI), fasting blood glucose (FBG), postprandial two-hour blood glucose (2hPG) and glycosylated haemoglobin (HbA1c) between the intervention group and the control group (p>0.05). Patients in the control group received their usual health management, while patients in the intervention group received mHealth management. Results After health management, the mean BMI, FBG, 2hPG and HbA1c of the intervention group patients were all lower than those of the control group patients (p < 0.05), and the quality of life and self-management of the intervention group patients had significantly improved. Discussion mHealth management effectively showed significant reductions in BMI, FBG, 2hPG and HbA1c and improved quality of life and self-management among patients, which may be related to real-time feedback from an implantable glucose sensor and guidance from GPs through a mobile app. mHealth management is a very promising way to promote the health management of T2DM in China, and this study provides a point of reference for mHealth management abroad.

The Cardiovascular Events in Metabolic Surgery Compared to the New Classes of Glucose-Lowering Agents in Patients with T2DM

Type 2 Diabetes Mellitus is a prevalent chronic disease with several macrovascular and microvascular complications. Cardiovascular diseases including coronary artery disease and stroke are common macrovascular complication that reduces the quality of life and lead to early mortality. Additionally, they pose enormous socioeconomic burden on the societies and the governments. Therefore, any intervention that reduces the cardiovascular events in patients with diabetes will have positive impact of the patients and the society. Thus, this systematic review aimed to evaluate the cardiovascular events after metabolic surgery in comparison with the new classes of glucose lowering agents in patients with type 2 diabetes mellitus. The review included 11 randomized controlled trials to both GLP-1 RA and SGLT-2 i groups. It also included 7 metabolic surgery studies, 2 of these are randomized controlled trials and the other 5 are observational studies. These studies were the most relevant studies to the research question. The results revealed different baseline demographic and clinical characteristics between the medication trials and metabolic surgery studies. Moreover, it revealed significant reduction in cardiovascular events in metabolic surgery studies when compared to medication trials. It also showed significant HbA1c and weight reduction in the metabolic surgery group. The remission of diabetes was very high in the metabolic surgery group while none of medication trials accomplished diabetes recovery. However, both medication and surgery groups had adverse events. In conclusion, the review is consistent with previous literature. It suggests that metabolic surgery is more effective than medical therapy in reducing cardiovascular events. Although this conclusion should be interpreted with caution due to the differences in baseline characteristics between studies. In general, the review recommends younger adult diabetic patients with obesity and history of established cardiovascular diseases to undergo metabolic surgery. Whereas, older patients with history of cardiovascular disease should be advised to take one of the medications that has been proved to reduce cardiovascular events. Future studies that compare metabolic surgery and the new classes of the glucose lowering agents is recommended to confirm the findings in this review.

Improved Glycemic Control With a Digital Health Intervention in Adults With Type 2 Diabetes: Retrospective Study

BackgroundTraditional lifestyle interventions have shown limited success in improving diabetes-related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control.ObjectiveIn this study, we evaluated changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program.MethodsThe study employed a single-arm, retrospective design. A total of 950 participants with a hemoglobin A1c (HbA1c) baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. HbA1c was the primary outcome measure. Of the 950 participants, 258 (27.2%) had a follow-up HbA1c completed at least 90 days from program start. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program usage and HbA1c change. A repeated measures analysis of variance was used to evaluate the difference in HbA1c as a function of the measurement period (ie, pre-Vida enrollment, baseline, and postenrollment follow-up).ResultsWe observed a significant reduction in HbA1c of –0.81 points between baseline (mean 8.68, SD 1.7) and follow-up (mean 7.88, SD 1.46; t257=7.71; P<.001). Among participants considered high risk (baseline HbA1c≥8), there was an average reduction of –1.44 points between baseline (mean 9.73, SD 1.68) and follow-up (mean 8.29, SD 1.64; t139=9.14; P<.001). Additionally, average follow-up HbA1c (mean 7.82, SD 1.41) was significantly lower than pre-enrollment HbA1c (mean 8.12, SD 1.46; F2, 210=22.90; P<.001) There was also significant effect of program usage on HbA1c change (β=–.60; P<.001) such that high usage was associated with a greater decrease in HbA1c (mean –1.02, SD 1.60) compared to low usage (mean –.61, SD 1.72).ConclusionsThe present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program usage was associated with greater improvements in HbA1c. The findings of the present study suggest that a digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA1c. The study was limited by a nonrandomized, observational design and limited postenrollment follow-up data.

702-P: Glycemic Improvement in 5,094 Pediatric Patients with Type 1 Diabetes (T1D) Using the Omnipod Insulin Management System over First 90 Days of Use

Clinical outcomes describing real-world use of various devices by people with T1D are important to support decision-making. This retrospective study characterized patient-reported clinical outcomes in youth in the United States with T1D before (baseline) and 90 days after (follow-up) the initiation of a tubeless insulin pump (Omnipod® or Omnipod DASH® Insulin Management System). The primary outcome was change in self-reported HbA1c from baseline to follow-up. Secondary outcomes were change in self-reported total daily dose (TDD) of insulin and frequency of hypoglycemic events (HE) per week (#/week <70 mg/dL). Outcomes were assessed overall and stratified by prior treatment modality (MDI or CSII) and age group. Patients were aged 11.2±3.8y (mean ± SD). The overall change in self-reported HbA1c at follow-up was -0.5±1.6% (p<0.0001). Overall change in TDD of insulin was -1.2±12.3U/d and the self-reported HE frequency decreased significantly by -1.4±2.9 episodes per week (p<0.0001). Reductions in HbA1c, TDD and HE were seen regardless of prior treatment or age group (except for patients <6y who had a slight increase in TDD). In this large cohort of youth with T1D, initiation of a tubeless insulin pump was associated with significant reductions in HbA1c and number of HE after 90 days of use compared to prior MDI and CSII treatments and across age groups.View largeDownload slideView largeDownload slide DisclosureD. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. F. Lauand: Employee; Self; Insulet Corporation. L. M. Huyett: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. A. Chang: Employee; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. T. Ly: Employee; Self; Insulet Corporation.FundingInsulet Corporation

86-LB: Real-World Effectiveness of Oral Semaglutide (OS) from a U.S. Commercially Insured and Medicare Advantage Population

Background: With OS’s FDA approval in September 2019, this study sought to provide real-world evidence on its effectiveness in a cohort of early users. Methods: Claims and lab result data were used to identify T2D patients who initiated OS between 09/20/19 - 10/31/20 (first claim date set as index). Selected patients had ≥1 HbA1c result within both ≤3 months pre- and ≥3 months post-index and ≥ 12 months pre-index health plan eligibility. Study groups included: all patients, patients persistent on OS (those with a OS prescription within 1.5 times of days supply dispensed overlapping/in proximity to most recent post-index HbA1c), GLP-1 naive patients, and patients with a pre-index HbA1c >9%. Results: Of the 323 individuals with T2D initiating OS, 42.4% were female with a mean age of 55 years and 77% were GLP-1 naive. Mean HbA1c was significantly reduced in all patients (-0.9%) and subgroups (all p Conclusions: OS initiation was associated with a significant reduction in HbA1c and increase in HbA1c goal attainment in real-world practice in this preliminary cohort. Disclosure N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. M. Radin: Employee; Self; Novo Nordisk Inc. C. Gamble: Employee; Self; Novo Nordisk Inc. H. Tan: Other Relationship; Self; HealthCore. V. Willey: Employee; Self; HealthCore.

698-P: Glycemic Improvement in 11,273 Adults with Type 1 Diabetes (T1D) Using the Omnipod Insulin Management System over First 90 Days of Use

Real-world evidence describing clinical outcomes in people with T1D using various devices is important to support decision-making. This retrospective study characterized patient-reported clinical outcomes in adults in the United States with T1D before (baseline) and 90 days after (follow-up) the initiation of a tubeless insulin pump (Omnipod® or Omnipod DASH® Insulin Management System). The primary outcome was change in self-reported HbA1c level from baseline to follow-up. Secondary outcomes were change in self-reported total daily dose (TDD) of insulin and self-reported frequency of hypoglycemic events (HE) per week (#/week <70 mg/dL). Outcomes were assessed overall and by prior treatment modality (MDI or CSII) and age group. Patients were aged 40.3±15.2y (mean±SD) and 59.1% female (Table). The overall change in self-reported HbA1c at follow-up was -0.8±1.5% (p<0.0001). Overall change in TDD of insulin was -10.5±20.6U/d (p<0.0001) and the self-reported HE frequency decreased significantly by -1.4±3.0 episodes per week (p<0.0001). Reductions in HbA1c, TDD and HE were seen regardless of prior treatment or age group. In this large cohort of adults with T1D, initiation of a tubeless insulin pump was associated with significant reductions in HbA1c, TDD of insulin, and number of HE after 90 days of use compared to prior MDI and CSII treatments and across age groups.View largeDownload slideView largeDownload slide DisclosureG. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. F. Lauand: Employee; Self; Insulet Corporation. L. M. Huyett: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. A. Chang: Employee; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. T. Ly: Employee; Self; Insulet Corporation.FundingInsulet Corporation

468-P: Impact of Webinars and Telemedicine during COVID-19 Lockdown in Transforming Outcomes in 848 T2D Patients in India

Telemedicine (TM) continues to play a critical role in ensuring continuity of care in diabetes patients during Covid-19. This study is based on Diabetes Tele Management System (DTMS®), a TM-based follow-up program consisting of decision support system aided by a multidisciplinary diabetes team since 1997 and its role during Covid-19. We retrospectively assessed the effectiveness of DTMS® and fortnightly delivered diabetes-specific Covid-19 webinars during lockdown period in our country. HbA1c of 848 consecutive T2D patients (age 55.68 ± 12.82 yrs, duration of T2D 13 ± 8 yrs) before and after lockdown were extracted from EMR and analyzed. Patients were also interviewed for their feedback using a structured questionnaire. Statistically significant reduction in HbA1c(baseline 7.81±1.76%, final 7.53±1.54%;t=5.601, p< 0.001*) was observed post lockdown. Among the patients who utilized telemedicine facility, 92.5% reported TM consultations during Covid-19 as a highly satisfactory experience (Figure 1). Since these patients were already familiar with the use of TM, no additional training was required other than reinforcing the necessity for maintaining treatment goals due to association of poor diabetes control with severity of Covid. SMS, audio video consults and counseling were found to be highly effective in those patients who were sensitized for a stricter control during COVID pandemic.

690-P: Semaglutide in Patients with Type 2 Diabetes: Real-World Data from Spain

Once-weekly Semaglutide (OWS) is available for the treatment of patients with T2D (PwT2D) in Spain since May 2019. We examined the effect of OWS in glycemic and weight management in a real-world setting in Spain. Adult PwT2D that were prescribed OWS in 4 Hospitals in Madrid-Spain were identified. Patients with OWS withdrawal were excluded. Change in HbA1c and weight at 6±3 months (full cohort) and at 12±3 months (subgroup) was analyzed separately in GLP-1-naive and GLP-1-experienced patients. Baseline data is shown in Table-1. Significant HbA1c and weight reductions were found in both groups (GLP-1 naive and GLP-1 experienced). It was significant for both, the 6±3 month and the 12±3 month cohorts (Table-1). Conclusions: OWS treatment showed significant HbA1c and weight reductions in a real world setting in Spain, in GLP-1 naive and GLP-1-experienced PwT2D. Disclosure J. J. Cardenas-salas: Other Relationship; Self; AstraZeneca, Lilly Diabetes, Mylan N. V., Novo Nordisk, Sanofi. R. Sierra: None. B. Luca: Other Relationship; Self; Almirall, S. A., Lilly Diabetes, Menarini Group, Mundipharma International, Novo Nordisk, Sanofi. B. Sanchez: None. N. Modrono: Other Relationship; Self; Menarini. C. Casado: None. N. M. Sanchez: None. E. Cruces: Other Relationship; Self; other. C. Vazquez: None.

793-P: Dapagliflozin Improves Renal Function in Obese Indian Diabetics with Microalbuminuria

SGLT2 inhibitors have gained appreciation following their acceptance as a treatment modality for people with type 2 diabetes. These agents promote glucosuia blocking the reabsorption of glucose from the proximal convoluted tubules in the kidneys. Due to the direct role on the nephrons, initially there were some concerns over their use among the renal compromised individuals. Urinary albumin to creatinine ratio (UACR) is considered as one of the indicators to access the renal function and to classify chronic kidney disease. RAAS blockers are the standard therapeutic options for reducing urinary albumin excretion among those with or without diabetes. This study aimed to find the renoprotective effect of dapagliflozin (DAPA) among obese Indian type 2 diabetics (T2D) with microalbuminuria and compared that with RAAS blockers. We considered 182 obese adults (BMI ≥30 kg/m2) with T2D and microalbuminuria for this study. Subjects were randomized into 2 groups. Those in DAPA group (n = 86, M/F: 51/35) were administered DAPA 10 mg once daily with breakfast, whereas subjects in the comparator (RAAS) arm (n = 96, M/F 54/42) were prescribed RAAS blockers (ARBs or ACE inhibitors). From comparable UACR and HbA1c at baseline, both groups witnessed a significant decline in the UACR at 12 weeks of intervention (p&amp;lt;0.02). The change in the UACR from baseline was higher in the DAPA arm, though it was not statistically different from RAAS arm (145.7± 32.8 to 89.5 ± 35.8 mg/g vs. 131.5 ± 44.6 to 94.3 ± 28.2 mg/g). Additionally, DAPA arm in contrast to RAAS arm, proved their glycemic benefits by demonstrating a significant reduction in the HbA1c (1.5 ± 1.2% vs. 0.3 ± 0.6%). There was a drop in blood pressure in the study and comparator arms, but RAAS agents were found to be more effective in lowering blood pressure (P &amp;lt;0.03). Dapagliflozin exhibited significant and numerically better reduction in UACR compared to RAAS blocking agents among obese microalbuminuric diabetics. Use of dapagliflozin also resulted in significant Hba1c reduction. Disclosure H. Mahapatra: None. L. Mahapatra: None. M. Khuntia: None. A. K. Sahoo: None.

786-P: Glycemic Efficacy and Safety of Ertugliflozin (ERTU) in Patients with Type 2 Diabetes (T2D) and Chronic Kidney Disease Stage 3 (CKD 3): An Analysis from VERTIS CV

VERTIS CV was a cardiovascular (CV) outcome trial that evaluated the CV safety of ERTU in patients with T2D and atherosclerotic CV disease (ASCVD). This analysis assessed the glycemic efficacy and safety of ERTU in VERTIS CV patients with CKD 3. Among 8246 patients in VERTIS CV, 1776 patients with CKD 3 at baseline (BL) were identified based on an eGFR of 30-<60 mL/min/1.73 m2 (1319 patients with CKD 3A [eGFR 45-<60 mL/min/1.73 m2]), calculated via the MDRD equation. Efficacy endpoints were changes from BL in HbA1c, body weight (BW) and systolic blood pressure (SBP) to Week 18, when doses of background antihyperglycemics were to be held constant. Safety assessments included adverse event (AE) reports. BL characteristics did not differ across randomized groups in patients with CKD 3. At Week 18, significant HbA1c reductions from BL for ERTU 5 mg and 15 mg vs. placebo were observed in patients with CKD 3 and in the CKD 3A subgroup (Table). Significant placebo-subtracted reductions in BW (5 mg: −1.4 kg; 15 mg: −1.5 kg) and SBP (5 mg: −2.9 mm Hg; 15 mg: −3.2 mm Hg) occurred in the CKD 3 patients receiving ERTU. The incidence of overall AEs, symptomatic hypoglycemia, hypovolemia and kidney-related AEs did not differ between ERTU and placebo across CKD 3 subgroups. In patients with T2D, ASCVD and CKD 3, ERTU improved glycemic control, BW and SBP, and was generally well tolerated.View largeDownload slideView largeDownload slide DisclosureS. Dagogo-jack: Consultant; Self; Abbott, AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi US, Stock/Shareholder; Self; Aerami Therapeutics, Jana Care Inc. J. P. Mancuso: Employee; Self; Pfizer Inc., Employee; Spouse/Partner; Pfizer Inc., Stock/Shareholder; Self; Pfizer Inc., Stock/Shareholder; Spouse/Partner; Pfizer Inc. A. Raji: Employee; Self; Merck & Co., Inc. I. Gantz: Employee; Self; Merck & Co., Inc. R. E. Pratley: Other Relationship; Self; Hanmi Pharmaceutical, Merck Sharp & Dohme Corp., Metavention, Monster Energy Company, Inc., Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. D. Cherney: Other Relationship; Self; AbbVie Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Scientific Affairs, LLC., Lilly Diabetes, Merck & Co., Inc., Mitsubishi-Tanabe, Maze Inc, Prometic, Novo Nordisk, Sanofi. B. Charbonnel: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi, Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. D. K. Mcguire: Consultant; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., CSL Behring, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi. F. Cosentino: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Pfizer Inc., Speaker’s Bureau; Self; Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Mundipharma International, Novo Nordisk. W. J. Shih: None. J. Liu: Employee; Self; Merck Sharp & Dohme Corp. R. Frederich: Employee; Self; Pfizer Inc., Other Relationship; Self; Merck Sharp & Dohme Corp., Stock/Shareholder; Self; Bristol-Myers Squibb Company, Pfizer Inc.

77-LB: A Retrospective Analysis of the Association between HbA1c and Continuous Glucose Monitor Use for U.S. Patients with Type 2 Diabetes

Background: Use of real-time continuous glucose monitoring (rtCGM) reduces HbA1c in individuals with type 2 diabetes (T2D) treated with intensive insulin regimens in randomized clinical trials. However, the effects of CGM use on glycemia in T2D patients in real world settings, particularly those treated with less intensive therapies, has not been well studied. Materials and Methods: This large retrospective, observational analysis utilized data from the Optum Research Database (ORD) to assess the glycemic effects of CGM use (any CGM or real-time CGM [rtCGM]) compared with self-monitoring of blood glucoses (SMBG) within a large T2D population treated with intensive insulin therapy (IIT) and non-intensive therapies (NIT), including basal insulin only, and non-insulin medications. Outcomes were changes from baseline in HbA1c up to 6 months post index date in all patients and by treatment regimen. The percentage of patients who achieved ≥1.0 HbA1c reductions was also assessed. Results: Data from 82,983 eligible patients were assessed (Any CGM, n=1,406; rtCGM, n=148; SMBG, n=81,575). Significant HbA1c reductions were observed with Any CGM (-0.46) and rtCGM (-0.72) vs. SMBG (-0.09), ps &amp;lt; 0.001. HbA1c reductions were significant in CGM vs. SMBG users in the ITT (Any CGM, -0.38%; rtCGM, -0.68%, ps&amp;lt;0.001) and NIT groups (Any CGM, -0.67%, p&amp;lt;0.001, and rtCGM, -0.87, p=0.008). Significantly higher percentages of Any CGM and rtCGM vs. SMBG users achieved ≥1.0 HbA1c reductions in the IIT and NIT groups. Effects of Any CGM and rtCGM were attenuated but remained statistically significant in multivariate adjusted models for the overall T2D cohort. Conclusions: Use of CGM (Any CGM or rtCGM) confers notable benefits in improving glycemic control regardless of therapy regimen. These findings support expanding CGM access to the broader T2D population. Disclosure G. J. Norman: Employee; Self; Dexcom, Inc. M. L. Paudel: None. T. Bancroft: None. P. M. Lynch: Employee; Self; Dexcom, Inc.

PRO10 Indirect Treatment Comparison of Myalepta (Metreleptin) Compared to Best Supportive Care in Lipodystrophy

Metreleptin is the first approved medicine for the treatment of the complications of lipodystrophy. In the absence of head-to-head studies comparing metreleptin with best supportive care (BSC), the objective of this analysis was to estimate the treatment effect of metreleptin compared to BSC on the metabolic complications of lipodystrophy in generalised lipodystrophy (GL) or partial lipodystrophy (PL) patients. Patient-level data from two single arm studies were utilised to carry out an indirect treatment comparison: the GL/PL Natural History study, an observational study of patients receiving BSC, and the National Institute of Health (NIH) follow-up study, an extended follow-up to patients enrolled in the metreleptin NIH studies 991265/200110769. Analysis methodology was aligned to NICE Decision Support Unit guidelines. Two relevant adjustment methods were identified: multivariate regression and inverse probability weighting (IPW). Three covariates were included in the adjustment models – age, gender, and lipodystrophy type (generalised or partial). Outcomes evaluated included change in haemoglobin A1c (HbA1c), triglycerides, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) from baseline to 1 year, as well as the incidence of pancreatitis. The results supported statistical rationale for using the IPW methodology as the primary analysis. A statistically significant adjusted treatment effect (ATE) was estimated for change in HbA1c (-1.52%; p<0.001), triglycerides (-915 mg/dl, p<0.001), ALT (-44 U/L, p<0.001), AST (-28 U/L, p<0.001) and episodes of pancreatitis (odds ratio (OR): 0.94, p=0.01) for metreleptin versus BSC. Results were consistent across multivariate regression analyses. Metreleptin produced significant and clinical meaningful reductions in HbA1c, triglycerides, ALT, AST, and episodes of pancreatitis compared to BSC, and can be considered standard of care therapy to treat the metabolic complications in patients with lipodystrophy.

Real-world evidence on the effectiveness and safety of gliclazide extended release treatment in Indian patients with type 2 diabetes undergoing Ramadan fast: an analysis from the global DIA-RAMADAN study

Background. Glycaemic imbalance, especially hypoglycaemia, is one of the greatest risks for patients with type 2 diabetes mellitus (T2DM) during Ramadan fasting. This paper outlines the efficacy and safety of gliclazide extended-release (XR) in Indian patients with T2DM enrolled in the global DIA-RAMADAN study. Methods. Adults (aged ≥ 18 years) with T2DM who chose to fast during Ramadan and received a gliclazidebased regimen once daily for 90 days before Ramadan were included in the study. Baseline and end-of-study visits were conducted 6–8 weeks before and 4–6 weeks after Ramadan, respectively. The primary outcome was the incidence of ≥ 1 symptomatic hypoglycaemic event (HE). Changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), and body weight were secondary outcomes. Results. Among 246 Indian patients enrolled in the study, most (78.9%, n = 194) were at moderate/low risk as per the International Diabetes Federation and Diabetes and Ramadan guidelines. Most patients (69.1%) received gliclazide XR as monotherapy, and the rest received gliclazide XR with metformin or other antidiabetic therapy. Significant reductions in HbA1c (−0.5 ± 0.8%, P &lt; 0.001) and FPG (−21.8 ± 59.4 mg/dL, P &lt; 0.001) levels were observed but the slight reduction in body weight was not statistically significant (−0.3 ± 3.7 kg, P = 0.614) in patients post-Ramadan. Overall, no HE was reported in Indian patients with T2DM during Ramadan fasting. Conclusion. Overall, the effectiveness and safety of gliclazide XR in Indian patients were consistent with that observed in the global cohort. Gliclazide XR significantly reduced HbA1c with no incidence of hypoglycaemic events in Indian patients with type 2 diabetes undergoing Ramadan fast, suggesting that gliclazide XR may be used without dose modification at Iftar to maintain optimal glycaemic control during Ramadan.

Abstract #1042704: Effectiveness of Teleconsultations Across Middle East And Africa (MENA) and India In T2DM To Deliver Continuity of Care During The COVID-19 Pandemic

The COVID-19 pandemic has accelerated growth and acceptance of telemedicine services. We evaluated 110 patients across the SugarDoctor database who were already registered before the pandemic and were provided the teleconsultations during COVID-19 pandemic. The teleconsultations were distinctively structured to not just the reactively address the medical issues but also were structured to proactively deliver E health education over the online platform. There was a significant reduction in HbA1c from the mean baseline 9.5% (±1.7, 95% CI 9-10) to 8.6% (±2.5, 95% CI 7.9 to 9.3) (reduction of 0.9%, p = 0.0393). The overall time span in the HbA1c evaluation was 2.9 years (±1.3, 95% CI 2.5 to 3.3). 27 patients were from Mumbai and rest were from MENA, with majority of patients from Saudi Arabia. Varied issues were addressed ranging from HbA1c follow up to providing advise for management of diabetic foot ulcers.The patients expressed satisfaction over the virtual connect for the undivided attention that was provided, with reliable internet connectivity. The new eyeball connect based, remote digital diabetes consultation model has potential to improve glycemic care, which appears to have improvement in the overall quality of life and in long term would mitigate complications due to T2DM. We attribute the impact of teleconsultations for the efficient delivery of diabetes care for the past efforts during the earlier face to face consultations to drive the importance of self-management of diabetes. The role of telehealth in T2DM has expanded dramatically during the coronavirus pandemic and would remain a major practical health care delivery modality going forward.

Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus) in Chinese adults with type 2 diabetes: A phase III, randomized, open-label, controlled trial.

AimTo compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with insulin glargine (Lantus; IGlar) combined with oral antihyperglycaemic medications (OAMs) in insulin‐naive Chinese patients with type 2 diabetes (T2D).Materials and MethodsIn this phase III, open‐label trial, adult patients with T2D receiving two or more OAMs at stable doses for 12 weeks or longer, with HbA1c of 7.0% or more and 11.0% or less, were randomized (2:1) to receive once‐daily LY IGlar or IGlar for 24 weeks. The primary outcome was non‐inferiority of LY IGlar to IGlar at a 0.4% margin, and a gated secondary endpoint tested non‐inferiority of IGlar to LY IGlar (−0.4% margin), assessed by least squares (LS) mean change in HbA1c from baseline to 24 weeks.ResultsPatients assigned to LY IGlar (n = 359) and IGlar (n = 177) achieved similar and significant reductions (p < .001) in HbA1c from baseline. LY IGlar was non‐inferior to IGlar for change in HbA1c from baseline to week 24 (−1.27% vs. −1.23%; LS mean difference: −0.05% [95% CI, −0.19% to 0.10%]) and IGlar was non‐inferior to LY IGlar. The study therefore showed equivalence of LY IGlar and IGlar for the primary endpoint. At week 24, there were no between‐group differences in the proportion of patients achieving an HbA1c of less than 7.0%, seven‐point self‐measured blood glucose, insulin dose or weight gain. Adverse events, allergic reactions, hypoglycaemia and insulin antibodies were similar in the two groups.ConclusionsOnce‐daily LY IGlar and IGlar, combined with OAMs, provide effective and similar glycaemic control with comparable safety profiles in insulin‐naive Chinese patients with T2D.