Active clinical trials for "Diabetes Mellitus, Type 1"

This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes. Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.

The purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improve glycemic control vs. usual care for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.

The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .

The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (T1DM), however after a meal sugars are always a concern. There is a drug sitagliptin (Januvia) which is FDA approved to treat people with type 2 diabetes which helps correct their glucose (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with type 1 diabetes. To test this, you will be given a mixed meal and its effects on insulin levels. The hormones that affect blood glucose as well as your sugar levels will be measured by a series of blood tests. We will also look for high blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify, you will be given sitagliptin (Januvia) 50 mg and 100 mg dosages. You and the researchers will not know which dose you are taking at any single visit. We will first enroll 10 subjects with established type 1 Diabetes Mellitus for at least 1 year, between the ages of 18-30 years old. The first 10 patients will be evaluated for safety parameters such as ability to keep blood sugars < 70 mg/dl for at least 70% of the time, no episode of severe hypoglycemia (low blood sugars) and so on. After this safety criteria is established, we will then recruit subjects between the ages of 14-19 yrs for the next phase of the study. A total of 17 subjects were enrolled into the study.

This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre study of 52 weeks treatment duration. The primary objective is to evaluate the efficacy(on endogenous insulin secretion), safety and tolerability of weekly albiglutide (a glucagon-like peptide-1 receptor (GLP-1R) agonist) versus placebo when added to insulin therapy in subjects with new-onset type 1 diabetes mellitus (NOT1DM) and residual insulin production.. Approximately 68 eligible subjects will be randomised in a 3:1 ratio such that 51 subjects receive albiglutide 30 milligram (mg) once weekly (with increase to 50 mg once weekly at Week 6 if the 30-mg weekly dose is tolerated) added-on to insulin therapy and 17 subjects receive placebo once weekly added-on to insulin therapy. The total duration of a subject's participation will be approximately 72 weeks (up to 8 weeks of Screening, 52 weeks of treatment and 12 weeks of Post-treatment Follow-up)

This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention. The study's specific aims and hypotheses are as follows: Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care. Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants. Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT). Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants. Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline. Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).

Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar are paving the way to revolutionize the management of this disease. The benefit of improved control of blood sugar levels compared to standard insulin pump therapy has already been demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably during exercise. The investigators research group has shown that small doses of glucagon can prevent low blood sugar when used in a blood sugar control system in patients with type 1 diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the ability to recognize the onset of physical activity in order to appropriately adjust the insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia. The purpose of this study is to test how well a new modified blood sugar control system controls blood sugar during exercise compared to: 1) the current system without modifications and 2) standard insulin pump therapy.

The purpose of the investigators study was to determine the effect of dietary protein restriction on survival and progression to end stage renal disease (ESRD) in diabetic nephropathy.