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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-05

Study Completion Date

2024-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

No Intervention: Observational Cohort

Intervention Type OTHER

No intervention

Interventions

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No Intervention: Observational Cohort

No intervention

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No