Active clinical trials for "Diabetes Mellitus, Type 1"

Patients suffering from diabetes through many years have a risk of developing late diabetic complications including changes in eyes, kidney, vessels and nerves. Late complications can be postponed or avoided when assuring a good diabetes control, i.e. sensible diet, exercise, frequent blood glucose measurements and a good medical treatment. Blood glucose regulation depends on two different factors i.e. the insulin need of the body and the amount of insulin in the body. The amount of insulin, in blood, is decided by the amount of insulin infused daily, whereas the insulin need depends on the patient's weight, physical activity and diet. Overweight type 2 diabetes patients have a large insulin need and especially this need is decisive for their development of diabetes. If these patients are treated with Metformin, blood glucose decreases and the result is an easier weight loss for the patient. Especially, when these patients take this drug, the development of late diabetic complications, especially arteriosclerosis, can be avoided or postponed. Whether these favourable effects of Metformin are also present in type 1 diabetic patients remains to be fully clarified, but some studies have indicated that this is the case. This results in a better regulation of diabetes on a smaller insulin dose than the one given to the patients before. Metformin probably takes effect by increasing the glucose uptake in muscles and by reducing the hepatic glucose production. The drug usually has no side-effects, but some patients do, however, suffer from abdominal pain, small tendency to nausea, loose defaecation and a metallic taste in the mouth. These side-effects are often temporary. Project description In total, 50 type 1 diabetic patients are offered to participate in the project. All are from the outpatient clinic at the Department of Endocrinology. The project lasts 7 months divided as follows: An introductory period of one month introducing an optimisation of the insulin treatment A 6 month period (in which neither the patients nor the treating doctor know which medication is given) with either T. Metformin treatment twice daily or T. Placebo (lime) twice daily together with the usual insulin treatment four times daily. Choice of either T. Metformin or T. Placebo will be made by draw, and as stated above, the drug type will be unknown for both the patient and the treating doctor in order to make sure that the investigation is as objective as possible. Throughout the examination period, the patients are asked to measure blood glucose four times daily, i.e. before main meals and before bed time. These values will be used for regulating the fasting insulin dose with help from the treating doctor, and for adjusting the daily insulin dose. During the first and the last two days of the examination period we will also ask the patients to measure blood glucose at 03h00 for two days. Those diurnal profiles will be included in the evaluation of the blood glucose control during the treatment period. Furthermore, the patients' blood pressures are determined during 24 hours before and after the 6 months' treatment period. This will be carried out automatically by means of a blood pressure cuff around the arm connected to a small apparatus registering the values during 24 hours. The apparatus can be taken home after installation at the outpatient clinic and can be carried around in a belt around the waist until next day where the apparatus will be dismantled. At the first and the last of 5 outpatient visits, blood tests will be taken (for evaluation of the long-term blood glucose, kidney, liver, insulin and fat in blood) and nocturnal urine must be collected and disposed in order to evaluate protein secretion and thereby kidney function.

The inclusion of "Timing of premeal insulin administration (Timing)" in an Intensive Insulin Therapy regimen will reduce A1C by an average of 1% in type 1 diabetic patients who have initial A1C's between 7.0% and 9.0%.

This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.

The aim of this study is to determine whether postprandial hyperglycaemia plays an important role in oxidative stress phenomena and influences their harmful effects on the arterial wall. 25 type 1 diabetic patients practicing FIT and with an HbA1c value of 8 percent or less at the beginning of the study will be recruited. The 25 control subjects will be recruited after the patients, so that they can be paired by age and sex. Patients will be randomized via an alternative cross over study design for 2 periods of 3 months, i.e. preprandial or postprandial injection of an ultra fast acting analog. During the 6 months of the study, slow acting analog doses will be adjusted on the basis of basal glycaemia values. The fast acting analog doses will be adjusted on the basis of an optimized algorithm available on each patient's PDA phone electronic diary. Blood and urine samples will be collected at M0, M3 and M6 to evaluate the stress oxidant grade and its consequence on atherogenesis: Oxidative Stress evaluation: plasma parameters (lipid peroxide derivatives, semicarbazide sensitive oxidase amine activity), erythrocyte and leukocyte cell parameters (reduced and oxidised glutathion, dismutase superoxide activity (SOD) Cu and Mn dependent, glutathion peroxidase, and catalase), urinary parameters (isoprostane F2) Evaluation of consequences of oxidative stress on atherogenesis processes: inflammatory parameters (CRP, TNFa, IL 6), adhesion molecules (VCAM 1, ICAM 1, P selectine), adipokines (leptine, resistine, adiponectine), coagulation factors (PAI 1), platelet and endothelial microparticles, The pre and postprandial glycaemic stability of each patient will be monitored using PDA phone systems, and HbA1c will be measured at M0, M3 and M6. Expected results and outcomes: It is important to know if, in patients with comparable glycaemic stability, these two insulin treatment regimens are associated with significant differences in oxidative stress and anti oxidant defenses. These results may help us to define a postprandial insulin treatment regimen (which is more flexible as regards meals) or a preprandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).

The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.

In this pilot study we are evaluating the efficacy of pramlintide on preventing weight gain among early onset type 1 diabetes. We are also evaluating the safety and the effects of treatment with pramlintide on early diagnosed type 1 diabetic subjects, especially among pediatric subjects.

A randomized, open-label, three-arm crossover study will be conducted. The aim of the study is to determine the effect of different isocaloric diet macronutrient compositions (High-carbohydrate-Low-fat-Low-protein (HCLFLP), Low-carbohydrate-High-fat-Low-protein (LCHFLP), Low-carbohydrate-Low-fat-High-protein (LCLFHP)) on plasma glucose dynamics in everyday life and during fasted exercise in persons with type 1 diabetes. Our hypothesis is that a HCLFLP diet reduce the decrease in plasma glucose from start to end of fasted exercise compared with a LCHFLP diet. Secondary a LCHFLP compared with a LCLFHP diet does not reduces the decrease in plasma glucose from start to end of fasted exercise. The current study will contribute with new knowledge about the importance of the compositions of a low-carbohydrate diet on glucose dynamics and the influence on plasma glucose during and after cycling in fasted state.

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense® 180 CGM System usage.

The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully automated system for intensive insulin treatment. Such system will ease the burden of constant treatment decision-making and at the same time it has the potential to safely intensify insulin therapy such that more patients can reach treatment goals. Currently, no off-the-shelf closed-loop system exists but research efforts in this field have been intensified and resulted in great progress in recent years. Most closed-loop systems consist of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For daytime blood glucose control, however, we believe that the system needs to be further advanced. Consequently, we have extended our single-hormone closed-loop system such that it now includes a second pump for glucagon delivery and correspondingly we have further developed our control algorithm to compute both insulin and glucagon dosages. We hypothesize that we have developed a safe and effective dual-hormone closed-loop system for patients with type 1 diabetes and that this system is superior to single-hormone closed-loop therapy. The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.

A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects. Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study. Accrual Objective 25 (3:2 randomization to active and control arms)