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

NCT07015970 | Completed DMC

• 1 other identifier: 2023-A01901-44
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (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

  One month

Secondary Outcomes (6)

• Time-in-Range

  One month

• Time Above Range

  One month

• Ajustement Practices

  One month

• ADDQoL questionnaire

  At inclusion

• DTSQs questionnaire

  At inclusion

Study Arms (1)

Adults with type 1 diabetes mellitus using AID and engaging in regular physical activity

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention

Adults with type 1 diabetes mellitus using AID and engaging in regular physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ISIS Diabete Service: lead

Study Sites (4)

CHU of Caen

Caen, 14033, France

Location

Institute of Diabetology

Mainvilliers, 28300, France

Location

CHRU of Nancy

Nancy, 54511, France

Location

University Hospitals of Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 40926369 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruno GUERCI, Professor, MD, PhD

  CHRU Nancy and University of Lorraine, Nancy, france

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 11, 2025
• Study Start: March 5, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: January 26, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)