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Diabetes Mellitus Type 1RAPPIDNCT07015970

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

An observational study of Diabetes Mellitus Type 1 and Glucose Metabolism Disorder, run by ISIS Diabete Service at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
87 participants
Where
4 sitesFrance
Study dates
5 Mar 2024to 15 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will be recruited by four specialized tertiary diabetes care centers (Vandœuvre-lès-Nancy, Strasbourg, Caen, and Mainvilliers).

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU of Caen

    Caen, 14033

  • Institute of Diabetology

    Mainvilliers, 28300

  • CHRU of Nancy

    Nancy, 54511

  • University Hospitals of Strasbourg

    Strasbourg, 67091

Other trials in France

About this study

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

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.

Read the 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.

Being tested
No Intervention: Observational Cohort
Keywords
Automated insulin delivery, Exercice, Diabetes Mellitus, Type 1, Hypoglycemia, Glycemic control
Medical subject headings
Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

    No intervention

Study groups in NCT07015970
Study groupRoleWhat they receive
Adults with type 1 diabetes mellitus using AID and engaging in regular physical activityNot described
Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: One month

Secondary outcomes (6)

  1. 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

    Measured: One month

  2. 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

    Measured: One month

  3. Ajustement Practices

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

    Measured: One month

  4. 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.

    Measured: At inclusion

  5. 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.

    Measured: At inclusion

  6. 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.

    Measured: At inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start5 Mar 2024
  3. Primary completion15 Dec 2024
  4. Study completion15 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015970
Sponsor's protocol ID
2023-A01901-44
Acronym
RAPPID
Status last verified
May 2025
First submitted
23 May 2025
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 40926369

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus Type 1 and Glucose Metabolism Disorder, run by ISIS Diabete Service at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Below Range (time frame: One month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07015970, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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