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

ISIS Diabete Service

Status: Completed

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

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07015970

2023-A01901-44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

87 participants in 1 patient group

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

Treatment:

Other: No Intervention: Observational Cohort