Active clinical trials for "Diabetes Mellitus, Type 1"

This study is designed to evaluate whether epigenetic markers in overweight men with type 1 diabetes (T1D) or type 2 diabetes (T2D) can be improved with a 3 month lifestyle intervention or program focused in glycemic intervention.

This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in young adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 150 young adults (age 18-35) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.

OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario. INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.

Over 300,000 people in Canada suffer from Type 1 Diabetes (T1D), a chronic condition whose incidence rate has been increasing in Canada every year by 5.1% (higher than the global average). While exogenous insulin injections allow those with T1D to live, it is not a cure, and those with T1D develop severe complications (kidney failure, cardiovascular disease). Strategies to regress the development of these complications, minimize healthcare system burden, and save the lives of Canadians are urgently needed. Undertaking regular exercise is an obvious strategy for those with T1D and has many well-established health benefits. Despite these benefits, adults with T1D exercise less frequently due to fear of severe hypoglycemia and a lack of knowledge of effective exercise strategies. Adding to this complexity, the investigators have recently shown that males and females elicit differential impairments in skeletal muscle metabolism in response to T1D. These differences may extend to the peripheral microvasculature and may lead to sexual dimorphism in the health benefits of exercise for those with T1D. Ultimately, developing a healthy muscle mass, including microvasculature, will help mitigate dysglycemic and dyslipidemic fluctuations and improve insulin sensitivity. The overarching purpose of this proposed study is to determine the impact of T1D on human skeletal muscle and its microvasculature over the lifespan in males and females, and its responses to exercise training and detraining.

Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are in high demand. The medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal. For this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type I diabetes. The main task of participants is to wear the investigational device during one week.

For children with type 1 diabetes (T1D), pain and needle phobia can cause postponing of changes in insulin pump infusion sets and continuous glucose monitors, and thus worsen glycemic control. We aim to assess the effectiveness of virtual reality (VR) technology, in reducing pain and anxiety, and improving regimen adherence and glycemic control among children with type 1 diabetes (T1D). Children with T1D, managed with continuous glucose monitoring and insulin pumps, will be recruited for a randomized cross-over trial. Children will be randomized to one of two interventions for diabetes management: group 1 will use VR glasses first and group 2 will listen to vocal-guided affective imagery first (audio). After 1 month, the interventions will be crossed over. The outcome measures will include pain and anxiety assessment, regimen adherence, glycemic control, and patient-reported outcome measures (PROMs) of VR satisfaction and effectiveness.

Type 1 Diabetes Mellitus (T1DM) is characterized by absolute insulin deficiency. Despite multiple daily insulin injections, glycemic targets are usually not achieved in T1DM patients.Use of continuos glucose monitoring system (CGMS) is associated with improvement in glycemic control and reduction in glycemic variability in T1DM subjects. real-time CGMS (rt-CGMS) and intermittently scanned CGMS (is-CGMS) are the newer CGMS technologies. Previous studies have shown that in T1DM patients rt-CGMS is better than is-CGMS for glycemic control and reducing hypoglycemic episodes in patients with impaired awareness of hypoglycemia, but in patients with normal hypoglycemic awareness this is not well established. This study is a randomized control clinical cross over study of 6 months duration in patients of T1DM having normal hypoglycemic awareness, with age 15-40 years with a HbA1c range of 8-12%. Following a training period of 2 weeks, 80 participants will be randomized into 3 arms in a ratio of 1:1:2 in rt-CGMS, is-CGMS and SMBG (self monitoring of blood glucose) arms, respectively. For the first two groups Medtronic Guardian Connect Sensor 3 and Abott Freestyle Libre Sensor 2will be applied for 2 weeks, respectively; followed by a crossover at 3 months withapplication of is-CGMS and rt-CGMS, respectively in these groups for a further 2 weeks period. For rest of the study duration these patients in the rt-CGMS and is-CGMS group will be monitored through SMBG. The 3rd SMBG group will act as control. Short term blood glucose control will be assessed by Fructosamine assay in the 2 CGMS groups and long term control by HbA1C.

The study will compare the postprandial responses to a test meal between subjects with type 1 diabetes and healthy control subjects, in terms of gut hormone levels, meal induced thermogenesis, hunger and satiety perception, as well as futher metabolic parameters.

While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the T1D population thereby preserving beta cell function.

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with type I diabetes (T1D). The digital health program, called Adhera® Caring, is designed to be used for approximately 3 months. The study will enroll 100 participants (20 in sub-study 1 and 80 in sub-study 2) who are caregivers of children with type 1 diabetes. There will be a nurse coaching the participants by providing support related to their emotional wellbeing via the mobile solution.