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RECRUITING

NCT06283797

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2024-05-29

Completion Date

2027-06-29

Last Updated

2025-04-06

Healthy Volunteers

Conditions

Diabetes

Interventions

DEVICE

OmniPod 5

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

DEVICE

Dexcom G6

Participants will use Dexcom G6 for continuous glucose monitoring

OTHER

PAID 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)

Inclusion Criteria: * 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 Exclusion Criteria: * Unwillingness of one parent or the legally responsible party to participate in insulin treatment * Any associated chronic disease or therapy (except insulin or L thyroxin at stable dose) affecting glucose metabolism * Therapy by automated insulin delivery using an insulin pump connected to continuous glucose monitoring sensor with a control algorithm (hybrid closed-loop system) * Cutaneous allergy or contact dermatitis to device (CGM or pod) adhesives * Insufficient vision and/or hearing to recognise all the functions of the Omnipod 5 system, including alerts, alarms and reminders in accordance with the instructions of utilization * Impaired cognitive or psychological abilities of the patient and/or his/her parents or the legally responsible party which may result in defective adherence to study procedures * Active enrolment in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date * Subject who is in a dependency or employment with the sponsor or the investigator * No signed informed consent form by the patient and his/her parents/legally responsible party * Subjects unable to attend all scheduled visits and to comply with all trial procedures * Law protected or deprived of liberty subject * Pregnant and breastfeeding women * Subjects no covered by public health insurance

Locations (4)

University Hospital, Angers

Angers, France

University Hospital, Montpellier

Montpellier, France

Robert Debré Hospital, AP-HP

Paris, France

University Hospital, Tours

Tours, France