24-hour Movement Behaviors in Adults With Type 1 Diabetes

NCT ID: NCT06425640

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2025-12-31

Brief Summary

Only 24.9% 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 (i.e. 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 (i.e. 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 participant's 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adults with type 1 diabetes

Adults with type 1 diabetes (25-50 years) will wear an accelerometer to objectively measure their 24-hour movement behaviors. An online questionnaire and food diary will be completed to gain insight into the explanatory variables of 24-hour movement behaviors. Information on glucose control will be collect through the continuous glucose monitor of the participant.

24-hour movement behavior

Intervention Type: BEHAVIORAL

Cross-sectional observational study investigating the 24-hour movement behaviors and glucose control

Interventions

24-hour movement behavior

Cross-sectional observational study investigating the 24-hour movement behaviors and glucose control

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults between 25 and 50 years
• Diagnosed with T1DM for a minimum of two years
• Minimal daily insulin dose of 10 units
• Using a continuous glucose monitor
• Most recent HbA1c between 6% and 9.5%

Exclusion Criteria

• Using a hybrid closed loop insulin pump
• Shift workers
• Known cardiovascular disease (e.g. peripheral arterial disease causing intermittent claudication reducing walking distance to <500 meters, history of cerebrovascular accidents with residual impact on motoric function or heart failure NYHA class 3 and 4)
• Physical disabilities that disturb daily functioning (e.g. amputations, paralysis)
• Other conditions affecting normal movement behaviors (e.g. active treatment for malignancies, diabetic nephropathy stage 4 or 5, chronic obstructive pulmonary disease stage 3 or 4 or asthma stage 3 or 4)
• Visual impairment (e.g. retinopathy with loss of vision or blindness)
• Hypoglycemia unawareness (i.e. self-reporting of biochemical hypoglycemia unaccompanied by symptoms, loss of autonomic symptoms (e.g. hunger, sweating) as initial sign of hypoglycemia)
• Symptomatic peripheral neuropathy(i.e. loss of sensations, pain, exaggerated sensitivity to painless stimuli, paresthesia, ulceration injuries or amputations)
• Professional or semi-professional top athletes
• Participating in another supervised healthy lifestyle or drug intervention

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Lapauw, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Eveline Dirinck, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Marieke De Craemer, Professor

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

University Hospital Ghent

Ghent, East Flanders, Belgium

Site Status: RECRUITING

University Hospital Antwerp

Antwerp, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Lotte Bogaert, PhD

Role: CONTACT

Lotte.Bogaert@ugent.be

093323638

Marieke De Craemer, Professor

Role: CONTACT

Marieke.Decraemer@ugent.be

09 332 52 08

Facility Contacts

Bruno Lapauw, Professor

Role: primary

Eveline Dirinck, Professor

Role: primary

Other Identifiers

ONZ-2023-0611

Identifier Type: -

Identifier Source: org_study_id