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Type 1 Diabetes clinical trials

View clinical trials related to Type 1 Diabetes.

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NCT ID: NCT06041971 Recruiting - Type 1 Diabetes Clinical Trials

Fully Closed Loop at Home (FCL@Home)

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The trial will aim to complete a total of 36 participants: 12 total participants within each age category and 18 participants within each HbA1c category; 12 participants at each site. The study may enroll up to 70 participants to account for dropouts across the study. The study will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel session, participants will undergo a 7 day/6-night remote monitored at-home use session. The study will also conduct a two-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy. Participants will be randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET use) or group B (control period after AIDANET use).

NCT ID: NCT06034574 Not yet recruiting - Type 1 Diabetes Clinical Trials

A Trial Investigating the Accuracy of Continuous Glucose Monitor Systems ("Supersapiens" Abbott Libre Sense and Dexcom G6) During Exercise in People With Normal Glucose Tolerance

SuperComEx
Start date: December 2023
Phase:
Study type: Observational

A two-phase, observational trial in an exercise laboratory and a prospective real-world setting to test the hypothesis that The Libre Sense Glucose Sport device has acceptable accuracy in people with normal glucose tolerance and comparable accuracy in the range of 3.0 to 11mmol/L to clinically approved CGM in people with type 1 diabetes.

NCT ID: NCT06021158 Recruiting - Type 1 Diabetes Clinical Trials

A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

Lilly-MEALS
Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. The investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes. Participants will test each meal strategy in random order, and each meal strategy will be 21 days long. For the duration of each meal strategy, participants will use an automated insulin delivery system or "artificial pancreas" with an ultra-rapid insulin called Lyumjev.

NCT ID: NCT06021145 Recruiting - Type 1 Diabetes Clinical Trials

Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes

Start date: March 2024
Phase: Phase 4
Study type: Interventional

The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve glucose control in individuals with type 1 diabetes who do not meet target recommendations for time in range (3.9-10.0 mmol/L). The main question it aims to answer is: - Will use of empagliflozin (2.5 mg/day) increase time spent in the target range of 3.9 to 10.0 mmol/L compared to placebo for individuals on an AID system who do not meet glycemic targets? Participants will either take 2.5 mg of empagliflozin or a placebo daily for 26 weeks while remaining on their current AID system.

NCT ID: NCT06018844 Not yet recruiting - Type 1 Diabetes Clinical Trials

Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus

Start date: April 2025
Phase:
Study type: Observational

The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D) The main question[s] it aims to answer are: - Does the intervention increase the amount of text messages between the mHealth software and participants? - Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants? - Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants? Participants will: - Receive text messages from the Nudge software - Report physical activity goals via the text messages to the Nudge software - Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation) - Complete surveys at the beginning of participation - Complete daily surveys while wearing the devices - Complete surveys at the end of participation - Record physical activity in study surveys

NCT ID: NCT06017089 Active, not recruiting - Type 1 Diabetes Clinical Trials

The Pediatric Artificial Pancreas Automated Initialization Trial

PEDAP-AI
Start date: November 10, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.

NCT ID: NCT06014879 Recruiting - Type 1 Diabetes Clinical Trials

EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

EMPoWER
Start date: August 7, 2023
Phase: N/A
Study type: Interventional

The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact. In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents, the study is first enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will be used in the intervention materials for the randomized clinical trial.

NCT ID: NCT06006468 Completed - Type 1 Diabetes Clinical Trials

Evaluating ImmuNe Changes in the Evolution of Pre Type 1 Diabetes With Adult ONset

INCEPTiON
Start date: February 1, 2023
Phase:
Study type: Observational

Little is known about how type 1 diabetes or coeliac disease develop in adults. Studies following children at risk of type 1 diabetes from birth have shown that the marker of type 1 diabetes autoimmunity (antibodies against the insulin producing cells in the pancreas (Glutamic Acid Decarboxylase Autoantibodies (GADA), Insulin Autoantibodies (IAA), Zinc Transporter 8 Autoantibodies (ZnT8), Anti-tyrosine phosphatase-like insulinoma antigen 2 (IA-2))) can develop many years before glucose levels are raised and diabetes is diagnosed. In adults, it is unclear when antibodies develop in relation to high blood glucose levels and the diagnosis of type 1 diabetes. Similarly in coeliac disease it is unclear to what degree Tissue transglutaminase autoantibodies (TTG) in adults proceed the development of clinically diagnosed disease. The investigators will use samples collected and stored in The Exeter 10,000 volunteer research bank (https://exetercrfnihr.org/about/exeter-10000/) and so no new sample collection is required. This includes ~8000 participants with no history of coeliac disease or diabetes at recruitment. The investigators wish to determine prevalence of autoantibodies in the background adult population split by the highest genetic risk for type 1 diabetes and separately coeliac disease compared to a control population with lower genetic risk for these conditions. The investigators will also evaluate the proportion of these identified cases progressing to clinically diagnosed disease. The aim of this study is to investigate evidence of autoimmunity prior to disease development and generate pilot data for the validity of screening based on genetic predisposition for type 1 diabetes and coeliac disease.

NCT ID: NCT05992350 Recruiting - Type 1 Diabetes Clinical Trials

Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)

Start date: January 16, 2024
Phase:
Study type: Observational

The goal of this observational study is to test the Garmin Vivosmart in children and youth (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer are: - Does the Garmin Vivosmart increase physical activity (PA)? - Does the Garmin Vivosmart improve T1D status Participants will: - Wear the Garmin Vivosmart (4 or higher) for a year - Complete surveys at the beginning, middle and end of participation asking about your T1D, T1D management, and PA - Parents of children will also complete similar surveys about T1D

NCT ID: NCT05985135 Not yet recruiting - Type 1 Diabetes Clinical Trials

Impact of Insulin Deprivation and Hyperglycemia on Plasma Protein Synthesis in People With Type 1 Diabetes Mellitus

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This research is being done to better understand how insulin effects muscle, blood, and the body in people with Type 1 Diabetes.