- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06283797
Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes (APATDIAGNOSIS)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric RENARD, MD
- Phone Number: 04 67 33 83 82
- Email: e-renard@chu-montpellier.fr
Study Locations
-
-
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Angers, France
- University Hospital, Angers
-
Contact:
- Régis Coutant, MD
- Phone Number: +33 02 41 35 56 55
- Email: recoutant@chu-angers.fr
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Montpellier, France
- University Hospital, Montpellier
-
Contact:
- Eric Renard, MD
- Phone Number: +33 04 67 33 83 82
- Email: e-renard@chu-montpellier.fr
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Paris, France
- Robert Debré Hospital, AP-HP
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Contact:
- Elise Bismuth Reisman, MD
- Phone Number: +33 01 40 03 20 67
- Email: elise.bismuth@aphp.fr
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Tours, France
- University Hospital, Tours
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Contact:
- Yannis Chartier, MD
- Phone Number: +33 06 85 67 93 35
- Email: Y.CHARTIER@chu-tours.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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 and the identification of at least one positive plasma auto-antibody among anti-GAD, anti-IA2 and anti-ZnT8
- 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
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 |
Intervention / Treatment |
---|---|
Experimental: Automated insulin delivery
Participants will use an automated insulin delivery system with study CGM
|
Participants will be trained to use OmniPod 5 to treat type 1 diabetes for 1 year
Participants will use Dexcom G6 for continuous glucose monitoring
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
|
Participants will use Dexcom G6 for continuous glucose monitoring
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
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric RENARD, MD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL22_0346
- 2023-A01661-44 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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