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This is a non-interventional, prospective, multi-site study conducted in France among adults with type 1 diabetes mellitus using automated insulin delivery (AID) systems and engaging in at least two exercise sessions per week, each lasting at least 30 minutes. The main objective of this study is to describe the glycemic control of athletic participants with type 1 diabetes mellitus who use an insulin pump with AID and engage in physical exercise under real-life conditions.
Two physician data collection time points are planned: the first occurs at baseline and includes demographic and clinical data, glycemic control during the month preceding inclusion, diabetes management, and information on usual physical exercise (duration, type, sport practiced, competition participation, and adherence to a specific diet). The second occurs at 1-month follow-up and involves downloading insulin pump and glucose sensor data, covering the period from 15 days before the first reported exercise session to 15 days after the last session.
During the 1-month study period, participants will complete a paper logbook after each exercise session to document information such as the type of exercise, self-reported intensity using the modified Borg scale and the WHO physical activity intensity scale, duration, system adjustments, dietary intake, occurrence of hypoglycemia and associated symptoms, snacks consumed, and treatments administered for hypoglycemia.
Three hybrid closed-loop systems dedicated to the automated management of type 1 diabetes are currently available in France: the Minimed 780G paired with the Guardian 4 continuous glucose monitoring system, Control-IQ, and mylife CamAPS-FX. Stratification will be performed based on the type of pump used by participants at the time of inclusion, at the national level, in order to obtain groups balanced in size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with type 1 diabetes mellitus using AID and engaging in regular physical activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Below Range | Percentage of time spent with glucose <70 mg/dL and <54 mg/dL before the exercise (within 2 hours prior), during exercise, during early recovery (within 3 hours after exercise), late recovery (from 3 hours after exercise to 8:00 a.m. the following day or until the next pre-exercise window, if closely), and during non-exercise periods | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Time-in-Range | Percentage of time spent in target glucose range 70-180 mg/dL before the exercise (within 2 hours prior), during exercise, during early recovery (within 3 hours after exercise), late recovery (from 3 hours after exercise to 8:00 a.m. the following day or until the next pre-exercise window, if closely), and during non-exercise periods | One month |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be recruited by four specialized tertiary diabetes care centers (Vandœuvre-lès-Nancy, Strasbourg, Caen, and Mainvilliers).
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| Name | Affiliation | Role |
|---|---|---|
| Bruno GUERCI, Professor, MD, PhD | CHRU Nancy and University of Lorraine, Nancy, france | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU of Caen | Caen | 14033 | France | |||
| Institute of Diabetology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40926369 | Result | Joubert M, Meyer L, Bekka S, Rakotoarisoa L, Scheyer N, Dreves B, Guerci B. Hypoglycemia incidence and behavioural adjustments during free-living unstructured physical activity in adults with type 1 diabetes using AID systems: Results from the RAPPID study. Diabetes Obes Metab. 2025 Dec;27(12):7221-7231. doi: 10.1111/dom.70122. Epub 2025 Sep 9. |
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In accordance with the General Data Protection Regulation and French data protection law, the presentation of the results derived from data processing shall under no circumstances allow the direct or indirect identification of individuals participating in the research.
In the event of publication of the research findings in a scientific journal, access to the data by an independent expert - including one appointed by a scientific publisher - shall only be granted through the interface provided or designated by the Data Controller, solely for the purpose of verifying or reproducing the analyses, and exclusively under the conditions defined for secure consultation and data handling.
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| Time Above Range | Percentage of time spent with glucose >180 mg/dL and >250 mg/dL before the exercise (within 2 hours prior), during exercise, during early recovery (within 3 hours after exercise), late recovery (from 3 hours after exercise to 8:00 a.m. the following day or until the next pre-exercise window, if closely), and during non-exercise periods | One month |
| Ajustement Practices | Reported by participants and available from insulin pump data before, during and after exercise sessions | One month |
| ADDQoL questionnaire | Self-administered questionnaire: Audit of Diabetes-Dependent Quality of Life (ADDQoL), including three scores: The first concerns the perceived quality of life, with 7 items ranging from "extremely poor" to "excellent." Total scores range from -3 to +3, with higher scores reflecting better quality of life. The second concerns the quality of life if the participant did not have diabetes, with 5 items ranging from "much better" to "worse." Total scores range from -3 to +1, with higher scores indicating that life would be significantly worse without diabetes. The third concerns the impact of diabetes on specific life domains, with 19 items ranging from "much better" to "worse," combined with the personal importance of each domain, rated from 0 (not at all important) to 3 (very important). The resulting weighted ADDQoL scores range from -9 to +3, with higher scores reflecting the maximum positive impact of diabetes. | At inclusion |
| DTSQs questionnaire | Self-administered questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQs), consisting of 8 items ranging from 0 to 6. Total scores range from 0 to 36, with higher scores indicating better treatment satisfaction. | At inclusion |
| HFS-II questionnaire | Self-administered questionnaire Hypoglycemia Fear Survey II (HFS-II) composed of two subscales: a Behaviour score and a Worry score, each consisting of 4 items rated from 0 (never) to 4 (almost always). Total scores range from 0 to 16 with higher scores reflecting greater behavioural or emotional impact. | At inclusion |
| Mainvilliers |
| 28300 |
| France |
| CHRU of Nancy | Nancy | 54511 | France |
| University Hospitals of Strasbourg | Strasbourg | 67091 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D044882 | Glucose Metabolism Disorders |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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