Active clinical trials for "Diabetes Mellitus, Type 1"

In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia. Hybrid closed-loop (HCL) therapy, automated insulin delivery using an insulin pump getting feedback from a continuous glucose monitor (CGM), may improve outcomes. This exploratory, novel pilot feasibility randomized clinical trial will evaluate pregnant women with type 1 diabetes (T1D) on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 2nd trimester, throughout pregnancy, and 4-6 weeks post-partum. Comparisons will be made on safety (Specific Aim [SA] 1), indices of glycemic variability and fear of hypoglycemia (SA 2), and quality of life and device satisfaction (SA 3) between groups. Exploratory SA 4 will compare maternal and fetal outcomes between groups. Safety data will include episodes of severe hypoglycemia requiring 3rd party assistance, diabetic ketoacidosis, and skin reactions. Glycemic control will be measured by CGM time spent in glucose ranges (<63, 63-140, >140 mg/dL) and other measures of glycemic variability. Subjects will fill out surveys (Fear of Hypoglycemia, a quality of life survey, and 2 questionnaires about device satisfaction) at baseline, throughout gestation, and early post-partum. Data on maternal and fetal outcomes will be collected. Findings will reveal the safety profile and glucose control with a novel therapy for pregnant women with type 1 diabetes.

A multi-center, randomized, crossover trial consisting of three sequential 12-week periods, with the HCL feature used during one period, the PLGS feature used during one period and SAP therapy (control) during one period. The crossover trial will be preceded by a run-in phase in which participants will receive training using the study devices (Dexcom G6 and Tandem t:slim X2 pump). After the last crossover period, participants will be given the opportunity to use study devices for an additional 12 weeks to assess preference of system use (PLGS, HCL or SAP) and associated characteristics, durability and safety in a more real-world setting with less frequent study contact.

Type 1 diabetes (T1D) results from the killing of insulin-producing pancreatic beta cells by cells of the immune system. The study aims to slow the progressive, immune-mediated loss of insulin-producing beta cells that occurs after clinical presentation. The investigators have identified a pathway that is important for immune cells to kill beta cells, and a drug that will block this pathway and prevent beta cell death. This drug, baricitinib, is already in clinical use for rheumatoid arthritis, and is currently in clinical trials for other diseases, including childhood autoimmune diseases. It is hypothesized that baricitinib treatment for 48 weeks will preserve beta cell function in children and young adults with recently-diagnosed T1D. The trial aims to recruit 83 participants aged 10-30 years who have been recently diagnosed with T1D. Two thirds of the participants will be randomly assigned to receive baricitinib, one third will receive placebo. The trial will test if baricitinib can slow the progressive loss of insulin-producing beta cells in these patients. The primary objective is to determine if baricitinib can reduce the loss of meal-stimulated plasma C-peptide, a measure of beta-cell function. Maintaining endogenous insulin in recent-onset T1D improves glucose control and may lead to long-term improvements in glucose and lower rates of serious diabetes complications and death.

Patients with type 1 diabetes usually present cardiovascular risk factors. Sixty percent of them are overweight or obese, 40% have hypertension, 60% have dyslipidemia, leading to cardiovascular disease as the major cause of death in adults with type 1 diabetes. Regular exercise can help patients to improve cardiovascular disease risk profile, metabolic control and chronic complications. Recommendations for exercise in children with diabetes are the same as the general population, between ages 8 to 18 years 60 min of physical exercise/day is suggested, including moderate or vigorous aerobic activity (at least 20 minutes), muscle strengthening and bone strengthening activities. Children with type 1 diabetes have poorer physical fitness levels than the non-diabetic peers and it has been described some barriers to meet these recommendations between children and adolescents with type 1 diabetes such as the fear of hypoglycemia, external temperature, work schedule, loss of control of diabetes, a low fitness level. The two types of exercise (aerobic and anaerobic) are recommended in people with diabetes. High intensity interval training involves alternation between brief periods of vigorous exercise and recovery at low to moderate intensity. Has been shown that HIIT is associated with improving aerobic capacity without a detrimental decline in blood glucose in adults with type 1 diabetes and home-based high-intensity interval training reduces barriers to exercise in the same group. The objective of the present study is to propose a HIIT exercise protocol through online modality to a group of adolescents with type 1 diabetes to evaluate the metabolic effects and physical capacity through an analytical, prospective and longitudinal study (before and after) for 3 months. As primary outcome is expected to improve metabolic control shown as an increase in time in range on continuous glucose monitoring and a decrease in glycosylated hemoglobin. And as secondary results, improve the aerobic capacity and resistance strength, lipid profile parameters, anthropometric and on the mood of the participants.

The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained. Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years, or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas. An additional adaptive trial for COVID-19 is also being conducted on these randomized double blinded type 1 diabetic subjects receiving BCG or placebo injections. An expanded study arm has been approved for repeat dosing of BCG in adult Type I diabetes.

SPECIFIC AIMS: To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation; To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation; To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus; To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells; and To assess the effect of infliximab in preventing early islet destruction, and thereby eliminating the need for a second donor's islet cells. To assess the effect of etanercept in preventing early islet destruction. To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin. To assess the ability of exenatide to improve islet survival at time of transplantation.

This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.

The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented pump therapy) for patients with brittle type1 diabetes.

Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.

There are evidences that some healthcare teams are not proposing new therapeutic and technology options that have the potential to reduce hypoglycemia for people with type 1 diabetes. In practice, people living with type 1 diabetes report receiving education related to insulin pumps usage mainly on key functions (how the device works) at initiation and not enough about proactive adjustments (how to optimally use the device) especially on the long-term. In brief, short-term education is technical and product-specific, rather than being based on patients' needs.There is a need to test the efficacy of different programs that may be more suited to patients' needs and desires while offering the opportunity to reduce costs (e.g. web based). Since there is a lack of expertise related to optimal use of new technologies and therapies for people living with type 1 diabetes, we propose to design and test a web-based training (e.g. courses including videos and quizzes) and support (e.g. discussion forum) platform. This will be tested through a registry-based trial. The overall purpose of this study is to evaluate, among a group of adults living with type 1 diabetes, the SUPPORT online education platform in terms of users' satisfaction, engagement and efficacy to change the fear and the frequency of hypoglycemia.