RecruitingNCT06460558

T1D Closed-loop and Physical Activity

"Impact of an Automated Closed-loop Insulin Infusion System on Adherence to Physical Activity in Patients With Type 1 Diabetes "


Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

65 participants

Start Date

May 6, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control \[1\] but also on reducing the incidence of diabetes-related complications \[2,3\]. It is recommended that patients living with T1DM perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity \[4\]. Indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 METs) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 METs) predicted lower all-cause mortality rates \[5\]. However, T1DM can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) \[6\]. The advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies \[7-9\]. The aim of this study is therefore to evaluate, in a cohort of patients with T1DM, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with T1DM. Based on the interpretation of the ONAPS-PAQ \[10\], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 MET/min/week threshold (considered ""Active+"" from this threshold onwards).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how well an automated insulin delivery (closed-loop) system manages blood sugar in people with Type 1 diabetes who are also physically active, to help understand how exercise affects automated glucose control. **You may be eligible if...** - You have Type 1 diabetes for more than 6 months and use an insulin pump - Your blood sugar control is not ideal (HbA1c ≥ 8%, frequent swings, or severe low blood sugars) - You live in the Alpes-Maritimes or Var regions of France - Women must use effective contraception and not be planning a pregnancy during the study **You may NOT be eligible if...** - You are already enrolled in another experimental study - You have a medical reason that prevents physical activity - You are pregnant - You are unable to understand written instructions due to language or cognitive barriers - You are under legal guardianship or restricted liberty Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERType 1 diabetes with insulin infusion system

No intervention


Locations(1)

CHU NiICE

Nice, Alpes Maritimes, France

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NCT06460558


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