Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425640
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-01
Brief Title:
24-hour Movement Behaviors in Adults With Type 1 Diabetes
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
INTERPLAY WITHIN THE DAY Optimizing Intra-day Glucose Control by Intervening on the Day-to-day 24-hour Movement Behavior Patterns in Adults With Type 1 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-06
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:
24h-MBs_T1D
Brief Summary:
Only 249 of the Belgian adults 25-50 years with type 1 diabetes mellitus T1DM achieve a good glucose control This can be explained by the challenging day-to-day diabetes management which places a substantial burden on this population However a tight glycemic control is fundamental in order to prevent the development of acute and chronic complications Despite the added value of continue glucose monitors to glucose control optimizing daily glucose levels is still problematic in adults with T1DM In addition to self-monitoring of blood glucose a healthy lifestyle with sufficient physical activity PA limited sedentary behavior SB and sufficient sleep time and quality is crucial for a good glucose control A recent shift in health promotion stresses the importance of considering all these behaviors ie PA SB and sleep in one 24-hour day instead of focusing on one behavior in isolation The aim of this study is to investigate the association between the day-by-day 24h-MB patterns of adults 25-50 years with T1DM and their intra-day glucose control ie time in range and coefficient of variation on the one hand On the other hand associations between he 24-h MB patterns and explanatory variables and cardiometabolic health markers will be investigated To gain insight into the 24-hour behavior of adults with type 1 diabetes 150 adults with type 1 diabetes will wear an Actigraph accelerometer for 14 consecutive days Daily glucose control will be measured using the participants continuous glucose meter Information about the explanatory variables and cardiometabolic health will be obtained by means of a questionnaire diary and a few measurements blood pressure weight length Advanced Glycation Endproducts hip-and waist circumference during a one-off visit to one of the recruitment- and testing centers namely University hospital of Ghent or University hospital of Antwerp The results of this cross-sectional study will inform future interventions focusing on the 24-hour movement behaviors in adults with T1DM
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