Skip to main content
OpenTrials
Completed

NCT Number: NCT07015970

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Fear of Hypoglycemia Glucose Metabolism Disorder Glucose Metabolism Disorders Glycemic Control for Diabetes Mellitus Hypoglycaemia Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life Treatment Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU of Caen, Caen, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. Time Below Range

    Time frame: One month

    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

Secondary outcomes

  1. Time-in-Range

    Time frame: One month

    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

  2. Time Above Range

    Time frame: One month

    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

  3. Ajustement Practices

    Time frame: One month

    Reported by participants and available from insulin pump data before, during and after exercise sessions

  4. ADDQoL questionnaire

    Time frame: At inclusion

    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.

  5. DTSQs questionnaire

    Time frame: At inclusion

    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.

  6. HFS-II questionnaire

    Time frame: At inclusion

    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.

Sponsors and collaborators

Lead sponsor

ISIS Diabete Service

Other

Registry information

Official study 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

Acronym: RAPPID

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.