View clinical trials related to Type 1 Diabetes.
Filter by:Increased glycemic variability has been proposed as an independent predictor of hypoglycemia in diabetic patients. Likewise, episodes of dysglycemia have been found to be predictive of diabetes in antibodypositive nondiabetic individuals. We hypothesise that an in-depth observational study comparing state-of-the-art measures of functional beta cell mass and glycemic variability will specify the relationship between both variables over a broad range of residual function and will identify treatment goals for functional beta cell mass to be reached in future beta cell therapy trials in order to avoid frequent hypoglycemia in patients and dysglycemia in risk groups. The available expertise and infrastructure (see background and (inter)national context) place the promoters of the present project in a unique position to carry out the planned experiments and support their feasibility.
High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay glucose absorption and reduce postprandial glycemic excursion. They also appear to have a beneficial effect on cholesterol levels. It has been shown, in few short term adult studies, that high fiber foods reduce postprandial blood glucose levels. The American Diabetes Association feels that there is little evidence confirming the positive effect of high fiber foods on blood glucose control. It is not clear whether a high fiber diet can improve glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that children with type 1 diabetes will benefit from having added fibers in their diet. The investigators plan to study blood glucose values using a continuous blood glucose monitor before and after dietary fibers are introduced. This will help us determine whether a diet rich in fiber should be recommended in all children with type 1 diabetes mellitus
Rationale: For the development of a closed loop system, faster insulin absorption after bolus administration could help to reduce the system's delay and thus increase patient safety. It has been shown that regular insulin absorption is faster when injecting insulin with a sprinkler needle (containing holes in the walls and being sealed at the tip). The current study will evaluate the impact of different application volumes on pharmacokinetic and pharmacodynamic properties of rapid acting insulin analogue (insulin aspart). Objective: To compare the pharmacokinetic response (based on the time to maximum observed serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with type 1 diabetes. Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study. Population: Twelve type 1 diabetic subjects Intervention: The investigational treatment is the subcutaneous administration of insulin aspart either as one bolus of 18 IU at one injection site or as 9 separately and simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days. Main study endpoint: Time to maximum observed serum insulin aspart concentration.
People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous insulin infusion (CSII) therapy, in which a background or basal level of insulin is constantly infused under the skin by a special pump, with bolus doses of insulin given to accompany food. Clinical experience suggests that this may be particularly useful for managing diabetes for exercise, but there is limited experimental evidence to support this. The aim of this research , which is divided into three parts, is to investigate the hypothesis that the physiological response to sub-maximal (moderate) exercise of a person with type 1 diabetes treated with CSII, can be made to approximate more closely to the physiological response of a healthy individual by a prior reduction of their basal insulin infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have an immediate effect on levels of insulin in the body, and evidence from adults suggests that the level of insulin in the bloodstream at the start of exercise is an important factor in whether hypoglycaemia develops during exercise. This suggests that reducing the basal insulin infusion rate some time before exercise may be useful. The aim of this study is to compare the effect of a basal insulin reduction on blood glucose levels between visits when this reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90 minutes before. The null hypothesis to be tested is that there is no difference between these conditions.
The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. The investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.
In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl. The investigators hypothesize that functional beta-cell mass will be more than 20% compared to healthy controls. Secondary outcome measurements: Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT. The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against base-line (base-line = before first intraperitoneal transplantation): - metabolic control - safety parameters - episodes of hypoglycemia - islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and alloantigens using pre-transplant measurements as base-line The investigators hypothesize that metabolic control and prevalence of hypoglycemia, will be significantly improved till PT month 12. Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time of the second implant. Comparison with composition of graft, identification of microenvironment of host origin and correlation with functional assessment will be performed.
DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. The investigators plan to include 300 type 1 diabetic children in 10 french hospitals.
IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The investigators recently showed that low dose IL-2 is well tolerated in patients with an autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg induction, the investigators aim to protect the remaining/regenerating β-cells from autoimmune destruction, thus improving or even curing T1D.
Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance as well as glycemic control after transition from pediatric to adult diabetes care.