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Type 1 Diabetes clinical trials

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NCT ID: NCT06300047 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Diabetes Transition Coordinator Study

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

The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis. The 3 main aims are: 1. To assess the effects of our transition intervention on clinical and patient-reported outcomes. 2. To implement the transition intervention and evaluate the implementation outcomes. 3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care. Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention.

NCT ID: NCT06208618 Enrolling by invitation - Type 1 Diabetes Clinical Trials

The Impact of Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The deterioration of glycemic control in adolescents with Type 1 diabetes (T1DM) is a genuine cause for concern. Possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment, pubertal increases in insulin resistance, and insufficient transition from pediatric to adult care. In adolescents with established T1DM who transition to adult-focused care, there is observed disengagement or complete detachment from care. Improving glycemic control during adolescence is a critical stage to enhance and reduce complications associated with T1DM. Adolescents with T1DM require appropriate daily insulin therapy, regular blood sugar monitoring, physical activity, healthy nutrition, education, and support to delay or prevent diabetes-related complications.This study aims to determine the impact of education and motivational interviews conducted through tele-nursing on the management of diabetes in adolescents with Type 1 diabetes.

NCT ID: NCT06177054 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Four-Week SkinSiteStudy in Type 1 Diabetes

SSS-4WK
Start date: December 8, 2023
Phase: N/A
Study type: Interventional

Using insulin pumps and sensors to monitor blood glucose has become standard of care for children with diabetes. The continous infusion of insulin in the subcutaneous tissue leads to increased risk of lipohypertrophy that might influence insulin absorption. We are in this study using ultrasound to detect subcutaneous hyperechogenicity to guide rotation of insulin infusion and investigate if avoidance of areas with hyperechogenicity improve insulin absorption seen as decrease in insulin needs.

NCT ID: NCT06057662 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes

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

The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are: 1. Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention. 2. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis Participants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.

NCT ID: NCT05854069 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes

Start date: April 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.

NCT ID: NCT05820477 Enrolling by invitation - Type 1 Diabetes Clinical Trials

FAMS-T1D Self-Regulation and Social Support for T1D

FAMS-T1D
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate how effective the FAMS-T1D intervention is for improving self-regulation (e.g., setting and meeting goals for type 1 diabetes) and social support for meeting those goals for young adults. The main questions that are examined include 1) whether the intervention improves blood glucose, self-management and diabetes distress across time, 2) whether these improvements occur through better self-regulation and social-regulation, 3) whether the intervention improves outcomes for support persons (a friend or family member invited to participate by the person with diabetes) without increasing support burden and 4) whether the intervention improves for persons with diabetes who are on continuous blood glucose monitor their time in range.

NCT ID: NCT05515939 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Evaluating the InPen in Pediatric Type 1 Diabetes

EMPoWER
Start date: September 9, 2022
Phase:
Study type: Observational

Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two decades. Despite advances in insulin delivery systems, fewer black and Hispanic children compared to white children with T1D use insulin pumps. Therefore, most minority children with T1D in urban areas require multiple daily injections (MDI) of insulin which may put them at increased risk of poor glycemic control. Although several factors contribute to worsening glycemic control in adolescents with T1D, studies have shown that missing doses of insulin at mealtimes is a major factor. Adolescents with T1D who use MDI with a basal-bolus regimen use formulas to calculate insulin doses that involve a four-step process. The complexity of determining insulin doses contributes to inaccuracies in both timing of doses and amount of insulin given, both of which can lead to hyperglycemia and hypoglycemia. The InPen™ Smart Insulin Pen System (Medtronics) was approved by the FDA for children of all ages with T1D in June 2020. The InPen is a Bluetooth-enabled smart insulin pen that helps with management of insulin dosing and tracking via capture of rapid-acting insulin doses and tracking of insulin in the body through the use of its companion app (free on Apple iOS and Android). The app includes a bolus calculator, which can lead to more accurate insulin dosing, which may improve glycemic control. The specific benefits of using the InPen include the following: simplifying insulin dose calculations, administering more accurate insulin doses, tracking insulin doses to help prevent hypoglycemia, providing reminders to administer insulin, and storing data in the InPen App that can be easily shared with diabetes healthcare teams to assist with adjusting insulin doses. The goal of this study is to determine if use of the InPen will improve glycemic control and diabetes numeracy in adolescents with uncontrolled T1D living in urban areas.

NCT ID: NCT05266963 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

CREON
Start date: September 2, 2022
Phase: Early Phase 1
Study type: Interventional

Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas. To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question. The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).

NCT ID: NCT04789993 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up

AADT1D
Start date: March 15, 2021
Phase:
Study type: Observational

This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France's centers of reference for paediatric diabetes.

NCT ID: NCT04677699 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Combined Antibody Screening for Celiac and Diabetes Evaluation

CASCADE
Start date: December 2020
Phase:
Study type: Observational

The CASCADE Study (Combined Antibody Screening for Celiac and Diabetes Evaluation) is an observational study whose primary goal is to show that population-based screening for advanced prediction of type 1 diabetes (T1D) and celiac disease (CD) is feasible to prevent diabetic ketoacidosis (DKA), improve celiac disease diagnosis, and ultimately gain public health acceptance to facilitate future prevention. It has two arms, a Birth Cohort and a Kids (cross sectional) Cohort.