Active clinical trials for "Diabetes Mellitus, Type 1"

This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.

The purpose of this study is to 1) convene African American and Latino Community Coalitions to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for African American and Latino parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the FT-P program among African American and Latino parents of school-aged children (5-9 years) withT1D. A randomized pilot trials will be conducted with African American and Latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through Baylor College of Medicine's Institute for Clinical Training and Research data management specialists.

The objectives of this study is to: Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion

This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe as part of the overall system.

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 dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp. The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

The overall aim of this research proposal is to determine the safety, feasibility and efficacy of an automatic closed-loop insulin delivery system.

The primary objective of this study is to evaluate the safety and efficacy of the Medtronic hybrid closed-loop (HCL) system utilizing the proportional-integral-derivative algorithm with insulin feedback (PID-IFB) optimized to function in a hybrid mode with closed-loop control operating during the day and night.

This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D). The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.

Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy at patients with type 1 diabetes at home Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at patient's home. The duration of study participation for one subject is 28-56 days and the overall duration of the study is 6 months The participants of the study are patients ≥ 10 years until 65 years with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose sensors. Sample Size n = 45

This study will enroll eligible subjects into a long-term safety study (Part B). Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to the screening visit. The study design of Part B is a randomized, open-label, 2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1 ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.