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Real-life Follow-up of the Physical Activity in Type 1 Diabetes Participants Equipped With an Insulin Pump With Hybrid Closed Loop

NCT07015970 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Type 1
  • Glucose Metabolism Disorder
  • Glycemic Control for Diabetes Mellitus
  • Fear of Hypoglycemia
  • Treatment Satisfaction
  • Quality of Life
  • Hypoglycaemia

Interventions

OTHER

No Intervention: Observational Cohort

No intervention

Sponsors & Collaborators

  • ISIS Diabete Service

    lead OTHER

Principal Investigators

  • Bruno GUERCI, Professor, MD, PhD · CHRU Nancy and University of Lorraine, Nancy, france

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2024-12-15
Completion
2024-12-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015970 on ClinicalTrials.gov