Active clinical trials for "Diabetes Mellitus, Type 1"

The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.

The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect in new onset pediatric Type 1 diabetes.

INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.

Primary objective: To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D). Secondary objectives: To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters. To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D. Exploratory objectives (if site is able and deems appropriate to accommodate and conduct these objectives): To determine the effects on insulin sensitivity and circulating markers of inflammation (leukocytes and inflammatory cytokines). Glycemic variability by additional CGM parameters. eGDR and BMI assessments.

OPERA Study is a randomized, open-label, prospective, pilot, and a monocentric clinical trial involving outpatients within Abu Dhabi Stem Cells Center (ADSCC) with a confirmed diagnosis of type 1 diabetes mellitus (T1DM). The patients will be randomly allocated (1:1) in a parallel assignment involving two groups of participants: Group A (Regular-intensity arm): Extracorporeal Photopheresis (ECP) on a regular-intensity regimen described in the Protocol as add-on T1DM standard of care, or Group B (Accelerated-intensity arm): ECP on an accelerated regimen plus T1DM standard of care.

This project is comprised of a two-arm randomized control trial (RCT) testing the feasibility, acceptability, and preliminary efficacy of a nationally scalable program, Activate, a 12-week, technology-delivered diabetes behavior-change skills training and physical activity promotion program for adolescents with type 1 diabetes. The researchers have a recruitment goal of 30 participants, but will enroll beyond 30 to address any withdrawal and ensure sample size is met. A primary goal of the study is assessing the feasibility and acceptability of the program, which combines two previously piloted components. Then, the investigators will compare the 12-week Activate program to a treatment as usual control group on proximal outcomes of behavior-change skills and daily active minutes. The investigators will also explore the impact of the Activate program on secondary mechanisms and outcomes linked with later type 1 diabetes health disparities: adolescent diabetes behavior regulation, psychological distress, inflammation, glycemic outcomes, and cardiovascular disease risk. It is hypothesized that a diabetes behavior-change skills training and physical activity intervention will be acceptable, and effective at improving behavior-change skills and daily active minutes, as well as other mechanisms and outcomes linked with later type 1 diabetes health disparities.

Our objective is to test the feasibility, acceptability, and initial efficacy of using behavioral economics incentives (BEI) in a novel, semi-automated intervention to target daily insulin BOLUS scores in adolescents with suboptimal insulin use.

The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells adjunct with Liraglutide on autoimmune diabetes.

In a multicenter, prospective, randomized, controlled clinical trial to compare influenza vaccination and placebo in sustaining β cell function in early type 1 diabetes mellitus.

Obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with obesity as well as potential mechanisms to modify disease.