T1D Closed-loop and Physical Activity

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Diabetes type1

Treatments: Other: Type 1 diabetes with insulin infusion system

Study type: Observational

Funder types: Other

Identifiers

NCT06460558

24Endocrino01

Details and patient eligibility

About

"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).

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-GAD or IA2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (HbA1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the CNAM for available systems.
• For women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period.
• Having a Health Care insurance."" "

Exclusion criteria

• Patient already involved in another experimental study
• Patient in a particular situation deemed incompatible with the study by the investigator
• Patient living in a department other than Alpes-Maritimes or Var
• Pregnant women
• Presence of a contraindication to physical activity
• Patient with linguistic or psychological incapacity to understand written information
• Patient refusing to give consent
• Patient deprived of liberty by administrative or judicial decision, under guardianship or trusteeship"" "

Trial design

65 participants in 1 patient group

Type 1 diabetes with insulin infusion system

Treatment:

Other: Type 1 diabetes with insulin infusion system