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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU NiICE
RECRUITING
Nice
Contact Information
Primary
Nicolas CHEVALIER, MD
chevalier.n@chu-nice.fr
0492035519
Backup
Enzo PINI
pini.e2@chu-nice.fr
0492035519
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2026-05-06
Participants
Target number of participants: 65
Treatments
Type 1 diabetes with insulin infusion system
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov

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