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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

• Aged between 2 and 17.9 years

• Diagnosis of type 1 diabetes since at least 3 months and up to 6 months based upon WHO criteria

• Identification of at least one positive plasma auto-antibody among anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin

• Treatment by multiple-daily insulin injections or insulin pump. An insulin pump with a function of stopping the pump in case of predicted hypoglycaemia is allowed.

• Patient and/or parents/guardians trained in carbohydrate counting

• Patient and/or parents/guardians must have a smartphone that supports the Dexcom G6 app download and participants must be willing to use Dexcom G6 sensor and app throughout the study

Locations
Other Locations
France
University Hospital, Angers
RECRUITING
Angers
University Hospital, Montpellier
RECRUITING
Montpellier
Robert Debré Hospital, AP-HP
RECRUITING
Paris
University Hospital, Tours
RECRUITING
Tours
Contact Information
Primary
Eric RENARD, MD
e-renard@chu-montpellier.fr
04 67 33 83 82
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2027-06-29
Participants
Target number of participants: 112
Treatments
Experimental: Automated insulin delivery
Participants will use an automated insulin delivery system with study CGM
Active_comparator: Conventional insulin therapy
Participants will use multiple insulin daily insulin injections or insulin pump with study CGM
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Tours, University Hospital, Angers, Hopital Universitaire Robert-Debre, University of Virginia
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov