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

April 3, 2025 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, open-label, multicenter, 1-year randomized control trial, followed by an optional 1-year extension. Based upon computed number of needed participants, 112 patients aged 2-17.9 with a diagnosis of T1D within 3-6 months, trained for meal carbohydrate counting (independently or with their parents/guardians) will be enrolled after written informed consent. All participants will be trained to guide their insulin doses from the data of Dexcom G6 CGM system during a 30-day run-in phase. Downloaded CGM data, measured HbA1c and stimulated C-peptide levels and answered study questionnaires at randomization visit will serve as baseline reference. The participants will be randomized 1:1 to either HCL or their usual insulin therapy by MDI or insulin pump (control group). Participants allocated to HCL and their parents/guardians will be trained to the study AID system. Safety phone visits will be scheduled 48 hours, 1 week and 2 weeks after HCL initiation. The participants randomized to the control group will go on using their usual insulin treatment while using the Dexcom G6 data to guide their insulin doses. Outpatient visits will occur every 3 months for one year in both study groups for the monitoring of glucose control (and HCL system functioning if applicable), safety and protocol adherence. At one year, study primary endpoint will be assessed, as well as all secondary study endpoints using a repeated measure ANOVA with within/between factor. After one year, the participants and their parents/guardians of the control group will be offered to switch to HCL with the study system for one year while the initial HCL system group will be offered to keep this therapy for an additional year, with quarterly monitoring visits in the whole population for this optional extension phase of the study. At the end of this extension, all study endpoints will be re-assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France
        • Recruiting
        • University Hospital, Angers
        • Contact:
      • Montpellier, France
        • Recruiting
        • University Hospital, Montpellier
        • Contact:
      • Paris, France
        • Recruiting
        • Robert Debré Hospital, AP-HP
        • Contact:
      • Tours, France
        • Recruiting
        • University Hospital, Tours
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Automated insulin delivery
Participants will use an automated insulin delivery system with study CGM
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)
Active Comparator: Conventional insulin therapy
Participants will use multiple insulin daily insulin injections or insulin pump with study CGM
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1c) level
Time Frame: At 1 year follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent of time spent in the 70-180 mg/dl glucose range
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Percent of time spent in the 70-140 mg/dl glucose range
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Mean glucose level
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Percent of time spent with glucose level below 70 mg/dl
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Percent of time spent with glucose level below 54 mg/dl
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Percent of time spent with glucose level above 180 mg/dl
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Percent of time spent with glucose level above 250 mg/dl
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Coefficient of glucose variability
Time Frame: At 1 year follow-up
Continuous glucose monitoring
At 1 year follow-up
Score of PAID questionnaire for parents
Time Frame: At 1 year follow-up
Change of score of PAID-PR in order to assess perceived burden of diabetes management
At 1 year follow-up
Score of PAID questionnaire for children
Time Frame: At 1 year follow-up
Change of score of PAID-Peds (age: 8-17) in order to assess perceived burden of diabetes management
At 1 year follow-up
Stimulated plasma C-peptide level 10-min after 1mg IV glucagon
Time Frame: At 1 year follow-up
Changes in stimulated plasma C-peptide level 10-min after 1mg IV glucagon in order to assess preserved endogenous insulin secretion
At 1 year follow-up
Number of needed interventions by the parents/guardians or care providers
Time Frame: At 1 year follow-up
Number of needed interventions by the parents/guardians or care providers to treat hypoglycemia, between randomized groups in order to assess occurrence of interventions for hypoglycemia
At 1 year follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
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
Time Frame: At 2 years follow-up
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
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of mean glucose level between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of percent of time spent with glucose level below 70 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of percent of time spent with glucose level below 54 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of percent of time spent with glucose level above 180 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of percent of time spent with glucose level above 250 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of coefficient of glucose variability between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of score of PAID questionnaire for parents between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of score of PAID questionnaire for children between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of stimulated plasma C-peptide level 10-min after 1mg IV glucagon between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Change of number of needed interventions by the parents/guardians or care providers between 1st and 2nd year of use in the group who started HCL early after diagnosis
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the percent of time spent in the 70-180 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the percent of time spent in the 70-140 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the percent of time spent with glucose level below 70 mg/dl between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the percent of time spent with glucose level below 54 mg/dl between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the percent of time spent with glucose level above 180 mg/dl between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the percent of time spent with glucose level above 250 mg/dl between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the coefficient of glucose variability between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the score of PAID questionnaire for parents between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the score of PAID questionnaire for children between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the stimulated plasma C-peptide level 10-min after 1mg IV glucagon between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Difference in the number of needed interventions by the parents/guardians or care providers between the 2 initially randomized groups at the end of the extension period
Time Frame: At 2 years follow-up
At 2 years follow-up
Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs
Time Frame: At 2 years follow-up
Evaluated at each visit until the end of study in order to assess the safety of studied intervention
At 2 years follow-up
Relatedness of treatment-emergent SUSARs, SAEs, ARs and AEs
Time Frame: At 2 years follow-up
Evaluated at each visit until the end of study in order to assess the safety of studied intervention
At 2 years follow-up
Severity of treatment-emergent SUSARs, SAEs, ARs and AEs
Time Frame: At 2 years follow-up
Evaluated at each visit until the end of study in order to assess the safety of studied intervention
At 2 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hopital Universitaire Robert-Debre
University Hospital, Angers
University of Virginia
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric RENARD, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL22_0346
  • 2023-A01661-44 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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