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

NCT06283797 | Recruiting FDA Device

• 2 other identifiers: RECHMPL22_03462023-A01661-44
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Diabetes

Keywords

Type 1 diabetes; Children and adolescents; Recent diagnosis of diabetes; Automated insulin delivery; Randomized control

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c) level

  Change in the HbA1c level, measured by HPLC method, from the start of the randomized study phase to the end of this 1-year study phase

  At 1 year follow-up

Secondary Outcomes (12)

• Percent of time spent in the 70-180 mg/dl glucose range

  At 1 year follow-up

• Percent of time spent in the 70-140 mg/dl glucose range

  At 1 year follow-up

• Mean glucose level

  At 1 year follow-up

• Percent of time spent with glucose level below 70 mg/dl

  At 1 year follow-up

• Percent of time spent with glucose level below 54 mg/dl

  At 1 year follow-up

Other Outcomes (29)

• Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis

  At 2 years follow-up

• Change of percent of time spent in the 70-180 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis

  At 2 years follow-up

• Change of percent of time spent in the 70-140 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis

  At 2 years follow-up

Study Arms (2)

Automated insulin delivery

EXPERIMENTAL

Participants will use an automated insulin delivery system with study CGM

Device: OmniPod 5; Device: Dexcom G6; Other: PAID questionnaires

Conventional insulin therapy

ACTIVE COMPARATOR

Participants will use multiple insulin daily insulin injections or insulin pump with study CGM

Device: Dexcom G6; Other: PAID questionnaires

Interventions

OmniPod 5 DEVICE

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

Automated insulin delivery

Dexcom G6 DEVICE

Participants will use Dexcom G6 for continuous glucose monitoring

Automated insulin delivery; Conventional insulin therapy

PAID questionnaires OTHER

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)

Automated insulin delivery; Conventional insulin therapy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Hopital Universitaire Robert-Debre: collaborator
• University Hospital, Tours: collaborator
• University Hospital, Angers: collaborator
• University of Virginia: collaborator

Study Sites (4)

University Hospital, Angers

Angers, France

RECRUITING

University Hospital, Montpellier

Montpellier, France

RECRUITING

Robert Debré Hospital, AP-HP

Paris, France

RECRUITING

University Hospital, Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric RENARD, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric RENARD, MD

CONTACT

04 67 33 83 82; e-renard@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control study in parallel groups, followed by a non randomized extension

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): June 29, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

FR (4)