DiabetesAPATDIAGNOSISNCT06283797
Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes
A study testing OmniPod 5, Dexcom G6 and PAID questionnaires in people with Diabetes, run by University Hospital, Montpellier at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Diabetes
- What is being tested?
- OmniPod 5, Dexcom G6 and PAID questionnaires
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 4 sitesFrance
- Study dates
- 29 May 2024to 29 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
University Hospital, Angers
Angers
Régis Coutant, MD, 02 41 35 56 55 ext. +33, recoutant@chu-angers.fr
- Recruiting
University Hospital, Montpellier
Montpellier
Eric Renard, MD, 04 67 33 83 82 ext. +33, e-renard@chu-montpellier.fr
- Recruiting
Robert Debré Hospital, AP-HP
Paris
Elise Bismuth Reisman, MD, 01 40 03 20 67 ext. +33, elise.bismuth@aphp.fr
- Recruiting
University Hospital, Tours
Tours
Yannis Chartier, MD, 06 85 67 93 35 ext. +33, Y.CHARTIER@chu-tours.fr
About this study
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
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- OmniPod 5, Dexcom G6, PAID questionnaires
- Keywords
- Type 1 diabetes, Children and adolescents, Recent diagnosis of diabetes, Automated insulin delivery, Randomized control
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniPod 5Device
Participants will be trained to use OmniPod 5 to treat type 1 diabetes for 1 year
Dexcom G6Device
Participants will use Dexcom G6 for continuous glucose monitoring
PAID questionnairesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Automated insulin delivery | Experimental | Participants will use an automated insulin delivery system with study CGM Receives: 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 Receives: Device: Dexcom G6; Other: PAID questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1 year follow-up
Secondary outcomes (12)
Percent of time spent in the 70-180 mg/dl glucose range
Continuous glucose monitoring
Measured: At 1 year follow-up
Percent of time spent in the 70-140 mg/dl glucose range
Continuous glucose monitoring
Measured: At 1 year follow-up
Mean glucose level
Continuous glucose monitoring
Measured: At 1 year follow-up
Percent of time spent with glucose level below 70 mg/dl
Continuous glucose monitoring
Measured: At 1 year follow-up
Percent of time spent with glucose level below 54 mg/dl
Continuous glucose monitoring
Measured: At 1 year follow-up
Percent of time spent with glucose level above 180 mg/dl
Continuous glucose monitoring
Measured: At 1 year follow-up
Percent of time spent with glucose level above 250 mg/dl
Continuous glucose monitoring
Measured: At 1 year follow-up
Coefficient of glucose variability
Continuous glucose monitoring
Measured: At 1 year follow-up
Score of PAID questionnaire for parents
Change of score of PAID-PR in order to assess perceived burden of diabetes management
Measured: At 1 year follow-up
Score of PAID questionnaire for children
Change of score of PAID-Peds (age: 8-17) in order to assess perceived burden of diabetes management
Measured: At 1 year follow-up
Stimulated plasma C-peptide level 10-min after 1mg IV glucagon
Changes in stimulated plasma C-peptide level 10-min after 1mg IV glucagon in order to assess preserved endogenous insulin secretion
Measured: At 1 year follow-up
Number of needed interventions by the parents/guardians or care providers
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
Measured: At 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 May 2024
- Primary completion29 Jun 2026 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control study in parallel groups, followed by a non randomized extension
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre, University Hospital, Tours, University Hospital, Angers, University of Virginia
- Responsible party
- Sponsor
- Investigators
- Eric RENARD, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283797
- Sponsor's protocol ID
- RECHMPL22_0346
- Other IDs
- 2023-A01661-44
- Acronym
- APATDIAGNOSIS
- Status last verified
- Apr 2025
- First submitted
- 21 Feb 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06283797
- Acronym / sponsor ID
- APATDIAGNOSIS / RECHMPL22_0346
- Conditions
- Diabetes
- Keywords
- Type 1 diabetes, Children and adolescents, Recent diagnosis of diabetes, Automated insulin delivery, Randomized control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre, University Hospital, Tours, University Hospital, Angers, University of Virginia
- Study start
- 29 May 2024 (actual)
- Primary completion
- 29 Jun 2026 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control study in parallel groups, followed by a non randomized extension
| Arm | Type | Receives |
|---|---|---|
| Automated insulin delivery | Experimental | Device: OmniPod 5, Device: Dexcom G6, Other: PAID questionnairesParticipants will use an automated insulin delivery system with study CGM |
| Conventional insulin therapy | Active comparator | Device: Dexcom G6, Other: PAID questionnairesParticipants will use multiple insulin daily insulin injections or insulin pump with study CGM |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmniPod 5Participants will be trained to use OmniPod 5 to treat type 1 diabetes for 1 year | Device | Automated insulin delivery |
| Dexcom G6Participants will use Dexcom G6 for continuous glucose monitoring | Device | Automated insulin delivery, Conventional insulin therapy |
| PAID questionnairesAt visits 3, 7 and 11, parents/guardians and patients aged between 8 and 17 will complete diabetes-related problem questionnaires (PAID-PR, PAID-Peds) | Other | Automated insulin delivery, Conventional insulin therapy |
Primary outcome
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
12 secondary outcomes
Percent of time spent in the 70-180 mg/dl glucose range
Time frame: At 1 year follow-up
Percent of time spent in the 70-140 mg/dl glucose range
Time frame: At 1 year follow-up
Mean glucose level
Time frame: At 1 year follow-up
Percent of time spent with glucose level below 70 mg/dl
Time frame: At 1 year follow-up
Percent of time spent with glucose level below 54 mg/dl
Time frame: At 1 year follow-up
Percent of time spent with glucose level above 180 mg/dl
Time frame: At 1 year follow-up
Percent of time spent with glucose level above 250 mg/dl
Time frame: At 1 year follow-up
Coefficient of glucose variability
Time frame: At 1 year follow-up
Score of PAID questionnaire for parents
Time frame: At 1 year follow-up
Score of PAID questionnaire for children
Time frame: At 1 year follow-up
Stimulated plasma C-peptide level 10-min after 1mg IV glucagon
Time frame: At 1 year follow-up
Number of needed interventions by the parents/guardians or care providers
Time frame: At 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric RENARD, MD principal investigator
University Hospital, Montpellier
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OmniPod 5, Dexcom G6 and PAID questionnaires in people with Diabetes, run by University Hospital, Montpellier at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric RENARD, MD (04 67 33 83 82, e-renard@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c) level (time frame: At 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.