Clinical trial NCT06460558: T1D Closed-loop and Physical Activity
Official title: "Impact of an Automated Closed-loop Insulin Infusion System on Adherence to Physical Activity in Patients With Type 1 Diabetes "
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes type1
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selection visit - Patients with T1DM referred to Nice University Hospital are offered the opportunity to take part in the study without obligation (D0).

Brief 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 criteria: 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"" "

Primary outcomes:
measure: IPAQ score
timeFrame: At the inclusion
Secondary outcomes:
measure: BAPAD-1 score "
timeFrame: At the inclusion
measure: BREQ-2
timeFrame: At the inclusion
measure: ONAPS PAQ
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NiICE
state: Alpes Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Nicolas CHEVALIER
role: PRINCIPAL_INVESTIGATOR
References: