Background Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes. Methods In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3·0 mg or matched placebo, as an adjunct to a reduced-calorie diet and increased physical activity. Time to diabetes onset by 160 weeks was the primary outcome, evaluated in all randomised treated individuals with at least one post-baseline assessment. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219. Findings The study ran between June 1, 2011, and March 2, 2015. We randomly assigned 2254 patients to receive liraglutide (n=1505) or placebo (n=749). 1128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomisation to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in the placebo group. Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomised individuals was 2·7 times longer with liraglutide than with placebo (95% CI 1·9 to 3·9, p<0·0001), corresponding with a hazard ratio of 0·21 (95% CI 0·13–0·34). Liraglutide induced greater weight loss than placebo at week 160 (–6·1 [SD 7·3] vs −1·9% [6·3]; estimated treatment difference −4·3%, 95% CI −4·9 to −3·7, p<0·0001). Serious adverse events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group. Interpretation In this trial, we provide results for 3 years of treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3·0 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes. Funding Novo Nordisk, Denmark
Mutations in glucokinase (GCK) cause a spectrum of glycemic disorders. Heterozygous loss-of-function mutations cause mild fasting hyperglycemia irrespective of mutation severity due to compensation from the unaffected allele. Conversely, homozygous loss-of-function mutations cause permanent neonatal diabetes requiring lifelong insulin treatment. This study aimed to determine the relationship between in vitro mutation severity and clinical phenotype in a large international case series of patients with homozygous GCK mutations. Clinical characteristics for 30 patients with diabetes due to homozygous GCK mutations (19 unique mutations, including 16 missense) were compiled and assigned a clinical severity grade (CSG) based on birth weight and age at diagnosis. The majority (28 of 30) of subjects were diagnosed before 9 months, with the remaining two at 9 and 15 years. These are the first two cases of a homozygous GCK mutation diagnosed outside infancy. Recombinant mutant GCK proteins were analyzed for kinetic and thermostability characteristics and assigned a relative activity index (RAI) or relative stability index (RSI) value. Six of 16 missense mutations exhibited severe kinetic defects (RAI ≤ 0.01). There was no correlation between CSG and RAI (r2 = 0.05, P = 0.39), indicating that kinetics alone did not explain the phenotype. Eighty percent of the remaining mutations showed reduced thermostability, the exceptions being the two later-onset mutations which exhibited increased thermostability. Comparison of CSG with RSI detected a highly significant correlation (r2 = 0.74, P = 0.002). We report the largest case series of homozygous GCK mutations to date and demonstrate that they can cause childhood-onset diabetes, with protein instability being the major determinant of mutation severity.
This study shows that FCGM-based AGP with FreeStyle LibrePro is associated with significant reductions in A1c levels in both T1D and T2D. In addition, improvement in A1c levels was maintained across all age groups and in patients enrolled at different diabetes clinics in India.
Maintaining a good glycemic control is crucial in the management of diabetes mellitus (DM) as it is associated with the reduction in both macro and microvascular complications of the disease. Self-monitoring of blood glucose (SMBG), which provides the day-today blood glucose levels, is a simple and practical tool for maintaining a good glycemic control. Although SMBG is widely practiced in other countries, its use in India is very limited. Even when used, it is not carried out is a structured manner. There seems to be a lack of education about the purpose of SMBG and the correct process and schedule to be followed. This highlights the unmet need for country-specific SMBG recommendations. In order to fulfil this need, a panel of expert endocrinologists/ diabetologists came together under the aegis of Research Society for the Study of Diabetes in India (RSSDI). They reviewed the current literature, combined the evidences with their clinical knowledge and expertise, and developed consensus recommendations for SMBG practice in India. This document provides a comprehensive review of the current literature on SMBG and presents the recommendations made by the expert panel.
Background: Insurers in South Asia are challenged by lack of a culturally relevant and clinically effective lifestyle intervention that can be delivered at scale. This study reports results from participants of a real-world pilot using Wellthy Diabetes™ (WD), a digital therapeutic for people living with type 2 diabetes, in collaboration with an insurance provider with the aim to validate WD as a diabetes management and risk reduction tool. WD was developed in scientific collaboration with the Research Society for Study of Diabetes in India (RSSDI). Methods: A 16-week lifestyle modification program was delivered to persons with T2DM through an Artificial Intelligence (AI) powered smartphone app. The program included behavioral modification training based on structured DSME content, developed along AADE7™ guidelines. The WD app enables users to self-report data on blood glucose, weight, meals, and physical activity and encourages logging through personalized reminders and nudges using an AI-powered digital persuasion model. Participants received real-time feedback and coaching through an AI-powered chatbot and personalized coaching from an expert diabetes coach. A1c measures were conducted at the start and end of the program. This study presents results from 102 program completers who completed follow-up A1c. Results: The mean pre and post-intervention A1c for 102 program completers (mean age: 50.8 years and 68% males) were 8.51% (95% CI:8.23-8.79) and 8.02% (95% CI: 7.72-8.32), respectively, showing a mean post-intervention reduction of -0.49% A1c (95% CI:-0.73 - -0.25, p=0.01). Sixty percent (n=61) of participants reduced their A1c by the end of the program with a mean reduction of -1.17% A1c (95% CI: 0.75-1.60). Conclusion: This study demonstrates Wellthy Diabetes as a clinically effective intervention for Health and Life Insurers in South Asia to improve health outcomes and reduce risk for people with type 2 diabetes through improved glycemic control. Disclosure A.R. Sosale: None. M. Shaikh: Employee; Self; Wellthy Therapeutics Pvt Ltd. A. Shah: Stock/Shareholder; Self; Wellthy Therapeutics.R. Chawla: None.B.M. Makkar: None. J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca.S. Joshi: None.N. Deshpande: None.S. Agarwal: None.A. Maheshwari: None.S. Madhu: None.B.D. Saboo: None.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.