RecruitingNot ApplicableNCT06283797

Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes

Assessment of the Efficacy of Automated Insulin Therapy (Artificial Pancreas) Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes: Randomized Comparison With Conventional Insulin Therapy on 1 Year, Followed by an Optional Extension on 1 Year


Sponsor

University Hospital, Montpellier

Enrollment

112 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use. The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump. An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase.


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether starting automated insulin delivery (a closed-loop system that automatically adjusts insulin based on a continuous glucose sensor) early after a Type 1 Diabetes diagnosis in children and adolescents leads to better blood sugar control compared to standard approaches. **You may be eligible if...** - You are between 2 and 17.9 years old - You were diagnosed with Type 1 Diabetes at least 3 months ago but no more than 6 months ago - You have tested positive for at least one diabetes-related antibody - You are on multiple daily injections or an insulin pump - You and/or your parents have been trained in carbohydrate counting - You have a smartphone compatible with the Dexcom G6 app **You may NOT be eligible if...** - Your parent or guardian is unwilling to participate in insulin management decisions - You have another chronic disease or are on other medications affecting blood sugar - You are already using a hybrid closed-loop insulin delivery system - You have a skin allergy to device adhesives - You or your family have significant cognitive or psychological challenges affecting device management Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOmniPod 5

Participants will be trained to use OmniPod 5 to treat type 1 diabetes for 1 year

DEVICEDexcom G6

Participants will use Dexcom G6 for continuous glucose monitoring

OTHERPAID questionnaires

At visits 3, 7 and 11, parents/guardians and patients aged between 8 and 17 will complete diabetes-related problem questionnaires (PAID-PR, PAID-Peds)


Locations(4)

University Hospital, Angers

Angers, France

University Hospital, Montpellier

Montpellier, France

Robert Debré Hospital, AP-HP

Paris, France

University Hospital, Tours

Tours, France

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NCT06283797


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