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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01661-44 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Hopital Universitaire Robert-Debre | OTHER |
| University Hospital, Tours | OTHER |
| University Hospital, Angers | OTHER_GOV |
| University of Virginia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated insulin delivery | Experimental | Participants will use an automated insulin delivery system with study CGM |
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| Conventional insulin therapy | Active Comparator | Participants will use multiple insulin daily insulin injections or insulin pump with study CGM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OmniPod 5 | Device | Participants will be trained to use OmniPod 5 to treat type 1 diabetes for 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of time spent in the 70-180 mg/dl glucose range | Continuous glucose monitoring | At 1 year follow-up |
| Percent of time spent in the 70-140 mg/dl glucose range | Continuous glucose monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric RENARD, MD | Contact | 04 67 33 83 82 | e-renard@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eric RENARD, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Angers | Recruiting | Angers | France |
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| OTHER |
Randomized control study in parallel groups, followed by a non randomized extension
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| Dexcom G6 | Device | Participants will use Dexcom G6 for continuous glucose monitoring |
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| 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) |
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| At 1 year follow-up |
| Mean glucose level | Continuous glucose monitoring | At 1 year follow-up |
| Percent of time spent with glucose level below 70 mg/dl | Continuous glucose monitoring | At 1 year follow-up |
| Percent of time spent with glucose level below 54 mg/dl | Continuous glucose monitoring | At 1 year follow-up |
| Percent of time spent with glucose level above 180 mg/dl | Continuous glucose monitoring | At 1 year follow-up |
| Percent of time spent with glucose level above 250 mg/dl | Continuous glucose monitoring | At 1 year follow-up |
| Coefficient of glucose variability | Continuous glucose monitoring | 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 | 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 | 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 | 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 | At 1 year 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At 2 years follow-up |
| Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period | 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 | 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 | At 2 years follow-up |
| Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At 2 years follow-up |
| Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs | 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 | 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 | Evaluated at each visit until the end of study in order to assess the safety of studied intervention | At 2 years follow-up |
| University Hospital, Montpellier | Recruiting | Montpellier | France |
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| Robert Debré Hospital, AP-HP | Recruiting | Paris | France |
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| University Hospital, Tours | Recruiting | Tours | France |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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