Actively Recruiting
Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes
Led by University Hospital, Montpellier · Updated on 2025-04-06
112
Participants Needed
4
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
H
Hopital Universitaire Robert-Debre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 2 and 17.9 years
- Diagnosed with type 1 diabetes 3 to 6 months ago using WHO criteria
- At least one positive plasma auto-antibody (anti-GAD, anti-IA2, anti-ZnT8, or anti-insulin)
- Currently treated with multiple daily insulin injections or insulin pump (pump with hypoglycemia stop function allowed)
- Patient and/or parents trained in carbohydrate counting
- Patient and/or parents have a smartphone supporting Dexcom G6 app and willing to use Dexcom G6 sensor and app during the study
You will not qualify if you...
- One parent or legal guardian unwilling to participate in insulin treatment
- Any chronic disease or therapy affecting glucose metabolism, except stable insulin or L thyroxin
- Currently using automated insulin delivery system with hybrid closed-loop
- Allergy or dermatitis to device adhesives (CGM or pod)
- Insufficient vision or hearing to use OmniPod 5 system functions
- Cognitive or psychological impairments affecting study adherence
- Active enrollment in another clinical trial or use of unapproved drug within 4 weeks before screening
- Dependency or employment with study sponsor or investigator
- No signed informed consent by patient and parents/legal guardians
- Unable to attend all visits or comply with study procedures
- Protected by law or deprived of liberty
- Pregnant or breastfeeding women
- Not covered by public health insurance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
University Hospital, Angers
Angers, France
Actively Recruiting
2
University Hospital, Montpellier
Montpellier, France
Actively Recruiting
3
Robert Debré Hospital, AP-HP
Paris, France
Actively Recruiting
4
University Hospital, Tours
Tours, France
Actively Recruiting
Research Team
E
Eric RENARD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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