Clinical trial NCT07015970: Real-life Follow-up of the Physical Activity in Type 1 Diabetes Participants Equipped With an Insulin Pump With Hybrid Closed Loop
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 1
Glucose Metabolism Disorder
Glycemic Control for Diabetes Mellitus
Fear of Hypoglycemia
Treatment Satisfaction
Quality of Life
Hypoglycaemia
Keywords: Automated insulin delivery
Exercice
Diabetes Mellitus, Type 1
Hypoglycemia
Glycemic control
Lead sponsor: ISIS Diabete Service
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be recruited by four specialized tertiary diabetes care centers (Vandœuvre-lès-Nancy, Strasbourg, Caen, and Mainvilliers).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Participants with decompensated cardiac disease
* History of severe hypoglycemia during physical activity in the past 6 months
* Participants with unresolved diabetic foot trophic disorders

Primary outcomes:
measure: Time Below Range
timeFrame: One month
Secondary outcomes:
measure: Time-in-Range
timeFrame: One month
measure: Time Above Range
timeFrame: One month
measure: Ajustement Practices
timeFrame: One month
measure: ADDQoL questionnaire
timeFrame: At inclusion
measure: DTSQs questionnaire
timeFrame: At inclusion
measure: HFS-II questionnaire
timeFrame: At inclusion
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU of Caen
city: Mainvilliers
country: France
facility: Institute of Diabetology
city: Nancy
country: France
facility: CHRU of Nancy
city: Strasbourg
country: France
facility: University Hospitals of Strasbourg
Study officials:
affiliation: CHRU Nancy and University of Lorraine, Nancy, france
name: Bruno GUERCI, Professor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: