Active clinical trials for "Diabetes Mellitus, Type 1"

Children with type 1 diabetes face complex self-management regimens which make adherence challenging and ultimately result in poor blood sugar control. Several common barriers interfere with diabetes control such as limited knowledge or challenges with staying motivated. Efficacious strategies exist to improve diabetes self-management including, but not limited to, diabetes education or family therapy. Patients and families often do not access these strategies, in part due to healthcare systems-based issues such as accessibility, provider availability, or insurance coverage. A family-centered approach has been suggested to tailor diabetes care to provide improved outcomes for each child. Family-centered care engages the family in the decision-making about the child's health and well-being. In this study we will take a family-centered approach to providing diabetes self-management by identifying families' unique self-management barriers through a 10-minute survey tool called PRISM (Problem Recognition in Illness Self-Management). Based upon the results of PRISM, we will provide tailored self-management resources (interventions) to meet the family's needs. We will coordinate group-based delivery of the resources with routine diabetes clinic visits. These group-based resources will be delivered in four 75-minute sessions over a year. The primary goal of this study is to compare the effectiveness of family-centered tailoring of diabetes self-management resources with the untailored approach of usual care. We hypothesize that the family-centered model of care with tailored resources will improve the outcomes of glycemic control and quality of life among children with type 1 diabetes and their parents.

A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias. The aim of the investigators study is to assess if these results are confirmed in a clinical trial. The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.

This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a range of single doses of subcutaneous insulin 338.

The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time. The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not. At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

Breif summary A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels has been an essential part of insulin dosing before meals. However, in recent years continuous glucose monitoring (CGM) has become a treatment option for notifying the patient on trends in glucose levels and warning when these are estimated to be too high and too low. In some countries today, Sweden among others, CGM is reimbursed in combination with continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a history of repeated severe hypoglycaemia in adult type 1 diabetic patients. This is based on existing clinical trials showing a beneficial effect on HbA1c by combining CGM with CSII. However, the majority of adult type 1 diabetic patients are treated with multiple daily insulin injections (MDI). Clinical trial data are sparse on the effect of CGM in adult type 1 diabetic patients treated with MDI, and there are no clinical trial data including only patients on MDI. The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction among adult type 1 diabetic patients on CGM treated with MDI. The design is a 69-week, cross-over clinical trial, including 26 weeks treatment with CGM, 26 weeks treatment with conventional SMBG and a wash-out period of 17 weeks. In total 120 patients will be included at 8 sites in Sweden. The study will have 80% power to detect a 3 mmol/mol (0.3 percentage unit) change in HbA1c resulting from CGM.

Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1 diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM measure the glucose level by a sensor in subcutaneous tissue, there is uncertainty in the estimation of blood glucose levels. The accuracy of a certain CGM system can be assessed by comparing the glucose levels estimated by CGM with measured glucose levels in plasma. In the current study, we will compare the accuracy of the 2 CGM systems available on the market for clinical use in patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic patients.

In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. Glucose control with automated closed loop control was comparable to patient-managed open loop control. The closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. The aim of this trial is to assess the efficacy of the new prototype at the home of the patient. It is hypothesized that the closed loop system provides better glucose control than standard open loop therapy.

This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.

The purpose of this study is examine the effect of different fat types on postprandial glucose control in patients with type 1 diabetes. Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals. The investigators hypothesize that, despite identical carbohydrate content,the lunches higher in saturated fat will lead to more postprandial hyperglycemia than the lunch containing minimal fat and the lunch high in monounsaturated fat. The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B, C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be greater than that of Lunch A and C.