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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Fear of Hypoglycemia; Diabetes Mellitus Type 1; Hypoglycaemia; Treatment Satisfaction; Glycemic Control for Diabetes Mellitus; Glucose Metabolism Disorder
• Intervention / Treatment: Other: No Intervention: Observational Cohort

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.

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CHU of Caen
  • Mainvilliers, France, 28300
    • Institute of Diabetology
  • Nancy, France, 54511
    • CHRU of Nancy
  • Strasbourg, France, 67091
    • University Hospitals of Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with type 1 diabetes mellitus using AID and engaging in regular physical activity	Other: No Intervention: Observational Cohort; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One month
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	One month
Ajustement Practices	Reported by participants and available from insulin pump data before, during and after exercise sessions	One month
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.	At inclusion
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.	At inclusion
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.	At inclusion

Collaborators and Investigators

• Sponsor: ISIS Diabete Service
• Investigators: Principal Investigator: Bruno GUERCI, Professor, MD, PhD, CHRU Nancy and University of Lorraine, Nancy, france

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: May 23, 2025
• First Submitted That Met QC Criteria: June 6, 2025
• First Posted (Actual): June 11, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Hypoglycemia; Glycemic control; Diabetes Mellitus, Type 1; Automated insulin delivery; Exercice
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypoglycemia; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders
• Other Study ID Numbers: 2023-A01901-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No