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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06460558
Other study ID # 24Endocrino01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 6, 2024
Est. completion date May 6, 2026

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Nice
Contact Nicolas CHEVALIER, MD
Phone 0492035519
Email chevalier.n@chu-nice.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date May 6, 2026
Est. primary completion date November 6, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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"" "

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Type 1 diabetes with insulin infusion system
No intervention

Locations

Country Name City State
France CHU NiICE Nice Alpes Maritimes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary IPAQ score "Measurement of IPAQ in METs/min/week (reflects the amount of physical activity practised using a validated questionnaire). There are seven items whose the result corresponds to the sum of the given figures. " At the inclusion
Secondary BAPAD-1 score " The BAPAD-1 score, validated in French, will be used to assess the usual obstacles to physical activity in T1DM. It is a Likert scale (between 0-7) composed by twelve items. Then, a mean is calculated with all the answers. At the inclusion
Secondary BREQ-2 "To assess motivation to engage in physical activity, use the BREQ-2 score, validated by ONAPS. It is a Likert scale (between 0-7) composed by six items. Then, a mean is calculated with all the answers. At the inclusion
Secondary ONAPS PAQ To assess sedentary behaviour, use the ONAPS PAQ score with only the sedentary behaviour section. 4 items. Then the sum of the results is calculated At the inclusion
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