NCT07015970Completed
Real-life Follow-up of the Physical Activity in Type 1 Diabetes Participants Equipped With an Insulin Pump With Hybrid Closed Loop
Suivi en Vie Réelle de l'Activité Physique de Patients Présentant un Diabète de Type 1 Sportifs Equipés d'Une Pompe à Insuline Avec Délivrance Automatisée d'Insuline
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 87 (actual)
- First submitted
- 23 May 2025
- Start date
- 5 Mar 2024
- Primary completion date
- 15 Dec 2024
- Lead sponsor
- ISIS Diabete Service
- Diseases
- Pompe disease, Type 1 diabetes
- NCT number
- NCT07015970
What you commit to
- Study type: Observational
- Participants enrolled: 87
- From 5 Mar 2024 to the primary completion date, 15 Dec 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with decompensated cardiac disease
- History of severe hypoglycemia during physical activity in the past 6 months
- Participants with unresolved diabetic foot trophic disorders
Other
- Participants currently enrolled in a clinical trial
- Pregnancy or breastfeeding women or women planning a pregnancy during the study
- Adults under legal protection (guardianship, curatorship, or judicial safeguard)
- Participants with decompensated retinopathy
Who the study is looking for
- Adult participants with diabetes mellitus type 1
- User for at least 3 months of one the three automated insulin delivery systems available in France at the time of the study (Minimed 780G pump + Guardian 4 sensor + PID-IFB algorithm; or T:Slim X2 pump + Dexcom G6 sensor + Control-IQ algorithm; or mylife Ypsopump + Dexcom G6 sensor + CamAPS FX app)
- Engaged in regular physical activity as part of daily life (at least 2 structured sessions per week, each lasting more than 30 minutes)
- Able to download data from the pump
- Willing and able to complete the physical activity log and self-questionnaires in French
- Having received the information sheet and given their oral consent (non-opposition) to participate in the study and for their data processing
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU of Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Institute of Diabetology Coordinator of this site? Confirm its status | Mainvilliers | France | Unknown status |
| CHRU of Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| University Hospitals of Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.