Active clinical trials for "Diabetes Mellitus, Type 1"

Type 1 diabetes is an autoimmune disease and results from T cell autoimmunity mediated destruction of the majority of insulin-producing pancreatic β-cells. Hence,the development of new therapies to control T cell autoimmunity, and to preserve the remaining β-cell function will be of great significance in managing patients with type 1 diabetes Autologous nonmyeloablative hematopoietic stem cell transplantation (AHST) has been tested for the treatment of patients with new onset of type 1 diabetes. This therapeutic strategy can result in exogenous insulin independence by destroying pathogenic memory T cells and preserving the remaining β-cell function. However, little is known about the efficacy of AHST in the dynamics of immunocompetent cell reconstitution and how the reconstituted immune system regulates β-cell specific antibody response. Furthermore, many Chinese patients at diagnosis of type 1 diabetes have progressed to develop diabetic ketoacidosis (DKA). Whether treatment with AHST could still achieve adequate glycemic control and preserve the β-cell function and what the factors are associated with the therapeutic efficacy have not been explored. This is a phase Ⅱ clinical trial in patients who have been diagnosed with type 1 diabetes within the previous 12 months.This study is to determine: The effects of autologous hematopoietic stem cell transplantation on the reconstitution of immune system β-cell preservation following stem cell transplantation The potential factors affecting efficacy of stem cell transplantation Whether this new therapy is safe.

Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.

The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be more effective if introduced in children and adolescents with established diabetes at the same time as they are starting pump therapy. This randomized controlled trial will compare the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and adolescents with type 1 diabetes who are starting insulin pump therapy.

The purpose of this research study is to test an automated blood glucose control system that includes a new component designed to adapt to stress. The importance of this component is that when Type 1 Diabetics are stressed (for example, from illness or infection), their body is resistant to the effects of insulin. The investigators will be adjusting their blood glucose using insulin and glucagon and making their body less sensitive to insulin with a steroid, hydrocortisone. Insulin is a hormone that lowers blood glucose. Glucagon raises blood glucose when it is low. Both are natural hormones made by people without diabetes. Hydrocortisone is a steroid that will increase their blood glucose temporarily and will be given every 4 hours. All subjects will participate in two 33 hour experiments. One experiment will use the adaptive version of the sensor-based glucose control system. The other study will use the original version of the control system, without the adaptive component, for the first 13 hours. Then, the adaptive component will be added to the glucose control system for the remaining 20 hours of the study. Our primary goal is to assess the effectiveness of the adaptive component to control glucose levels in the presence of steroid-induced insulin resistance in persons with Type 1 Diabetes Mellitus.

A greater visit frequency between the diabetes mellitus 1 (DM1) patient and the medical team increases the possibilities to improve metabolic control. The support of telematic visits can support the patient and the health system. Patients and Method: 160 patients (from 5 participating centres) with type 1 diabetes mellitus (DM1) candidates for improved metabolic control selected according to inclusion and exclusion criteria. The telecare system used is comprised of the patient Unit and the doctor Unit. The system allows the patient to send glucose values, insulin doses, carbohydrate contribution and other events via the internet. Both the patient and the professional can use this information via the telecare system platform. Work hypothesis The application of interactive telematic systems between patient-health team will improve the cost effectiveness of care programmes for optimisation of metabolic control directed towards diabetes mellitus (DM1) patients. Objectives: General Objective Evaluate the impact of the telecare system on the efficiency of economic and clinical management of human and material resources directed to a program of metabolic control optimisation in diabetes mellitus 1 (DM1) patients as well as the level of metabolic control and the quality of life of the patients. Specific objectives To identify and analyse the influence of the telecare system on patient costs in time, money and normal work or school activity which the patient has to stop to carry out the physical visits for following the programme. To identify and analyse the influence of the telecare system on medical team costs in time, money and care organisation directed towards the monitoring phase of the metabolic control care programme. To identify and analyse the influence of the telecare system on the level of metabolic control: Glycosylated haemoglobin and the presence of acute hypoglycemic and hyperglycaemic complications in diabetes mellitus 1 (DM1) patients that follow the metabolic optimisation programme. To identify and analyse the influence of the telecare system on the quality of life of the patient measured in satisfaction scale, impact, social/work concern and concern relating to diabetes. To identify and analyse the influence of the telecare system on the adherence to different treatment components.

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The main goal of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control. Each patient will be admitted twice to a clinical research facility. In one visit, patients will eat a morning meal accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. If post-meal glucose levels were indifferent between the two visits, then this would suggest that carbohydrate counting may not be necessary during closed-loop operation as the closed-loop system will give any remaining insulin needed to cover the glucose absorbed from the meal. Twelve subjects will be enrolled in this study.

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.

This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo. Subjects will initially be randomised to one of the three dose groups, and subsequently randomly allocated to one of two treatment sequences (liraglutide/placebo or placebo/liraglutide).

This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.