NCT06283797Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- May 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Type 1 diabetes
- NCT number
- NCT06283797
What you commit to
- Study type: Interventional
- Planned participants: 112
- From May 2024 to the primary completion date, Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active enrolment in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
Other illness
- Cutaneous allergy or contact dermatitis to device (CGM or pod) adhesives
Lab values
- 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)
Other
- Unwillingness of one parent or the legally responsible party to participate in insulin treatment
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| University Hospital, Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Robert Debré Hospital, AP-HP Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| university hospital, Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.