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Type1 Diabetes clinical trials

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NCT ID: NCT06253351 Recruiting - Adolescents Clinical Trials

Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age With Type 1 Diabetes

BFHado
Start date: March 13, 2024
Phase:
Study type: Observational

The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.

NCT ID: NCT06177691 Active, not recruiting - Type1 Diabetes Clinical Trials

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study

CLVerEx
Start date: May 7, 2021
Phase:
Study type: Observational

The purpose of this extension study is to continue to follow the participants who completed the CLVer RCT for up to 3 additional years. The goal for Cohort A is to evaluate the longer-term effects of verapamil on preservation of β-cell function as measured by C-peptide levels obtained during a mixed meal tolerance test (MMTT). For both Cohorts A and B, the goal is to determine if the high degree of glycemic control achieved during CLVer with HCL can be maintained once the intensive engagement of the study team is discontinued. At the completion of the RCT, study treatments end. Thus, during the extension study, diabetes management is performed as part of usual care and there is no study treatment.

NCT ID: NCT05876273 Completed - Type1 Diabetes Clinical Trials

Neural-net Artificial Pancreas (NAP)

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

This study is intended to assess a Neural-net Artificial Pancreas (NAP) implementation of an established AP controller - the University of Virginia Model Predictive Control Algorithm (UMPC). The health outcomes achieved on NAP will be compared to the health outcomes achieved on UMPC in a randomized crossover design. The investigators will consent up to 20 participants, ages ≥18.0, with a goal of completing 15 participants.

NCT ID: NCT05766657 Recruiting - Obesity Clinical Trials

Evaluation of an Anti-inflammatory Diet in Autoimmune and Metabolic Diseases

Start date: December 23, 2022
Phase: N/A
Study type: Interventional

The overall objective of the study is to provide personalized nutritional advice based on the gut microbiota profile of children with type 1 diabetes (T1D) or obesity. Specifically, the primary objective of NUTRI-DIET is to validate a dietary model aimed at restoring bacterial species and/or anti-inflammatory metabolites in order to prevent extra-intestinal diseases characterized by dysbiosis, such as T1D and obesity. The primary endpoints of the study will be to monitor the glycemic control indices, i.e., blood glucose (mean of glycemic values, percentage of time-in-range value (TIR), which will be displayed by glycemic sensor) and glycated hemoglobin for diabetic children and Body mass index (BMI) z-score according to World Health Organization (WHO) recommendations (WHO BMI-for-age boys; WHO BMI-for-age girls) for obese children. The secondary objective of the study is to characterize the microbiota profile of the study patients and to test the algorithm under development built from the integration of diet and and gut microbiota composition data that were obtained during the previous observational study NUTRI-T1D.

NCT ID: NCT05536232 Recruiting - Type1 Diabetes Clinical Trials

Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet

KetoDiab
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

Low Carbohydrate Diet (LCD) (< 130 g of carbohydrate per day) and ketogenic diet (< 50 g of carbohydrate per day) are popular among patients with type 1 diabetes (T1D). In most cases, LCD allow a better glycemic control and a important decrease of insulin requirements that cannot, however, be the sole result of low carbohydrate intake. However, due to the increase production of ketone bodies and the decrease of the insulin/glucagon rate, this diet is not without risk in T1D patients and some of them develop ketoacidosis. Type 1 diabetes is a autoimmune disease defined by the destruction of the pancreatic beta cells by the effector T cells, in condition of low regulatory T cells (Tregs). Indeed, some nutrients could regulate the plasticity and the function of Tregs, and be involved in the control of some autoimmune diseases in animals models thanks to a direct effect on immune cells of the digestive tract or an indirect effect by microbiota modulation. The study hypothesises that LCD may be able to restore residual insulin secretion in some patients by modulating immunity. The metabolic mechanisms leading to the effects described in patients with T1D patients under LCD have not been studied : in particular, there is no data on the evolution of the residual insulin secretion and no immunological parameter has been studied on these patients.

NCT ID: NCT04625595 Completed - Type1 Diabetes Clinical Trials

Multiple Ascending Dose (MAD) Study of IMT-002 in HLA-DQ8-positive Type 1 Diabetes

Start date: November 9, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to characterize the safety, steady-state pharmacokinetics (PK) of IMT-002, and will serve as a dose range identification for the pharmacodynamic effect of blocking self-antigen presentation in adults with type 1 diabetes (T1D) having the human leukocyte antigen (HLA)-DQ8 gene.

NCT ID: NCT04520971 Completed - Type1 Diabetes Clinical Trials

Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes

CRISTAL
Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).

NCT ID: NCT04255381 Completed - Type1 Diabetes Clinical Trials

Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)

HY-GRAID
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to 60 hours.

NCT ID: NCT04233034 Completed - Type1 Diabetes Clinical Trials

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes

CLVer
Start date: July 9, 2020
Phase: Phase 3
Study type: Interventional

Randomized trial of youth aged 7-<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight <30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.

NCT ID: NCT04002557 Completed - Type1 Diabetes Clinical Trials

Optimising Consultation Summaries to Promote Good Health

ONSET
Start date: May 31, 2019
Phase:
Study type: Observational

Patient participation in decision making about their care promotes patient satisfaction and confidence. Further more, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries. This research aims explore the views of adolescent patients related to consultation summaries that they receive following a doctor's appointment. The investigator will use patients attending a specialist diabetes clinic as our cohort and conduct a qualitative study using focus groups.