Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460558
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
T1D Closed-loop and Physical Activity
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Impact of an Automated Closed-loop Insulin Infusion System on Adherence to Physical Activity in Patients With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 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 45 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 METminweek threshold considered Active from this threshold onwards
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None