24-hour Movement Behaviors in Adults With Type 1 Diabetes

NCT06425640 | Recruiting

• 1 other identifier: ONZ-2023-0611
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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

Keywords

24-hour movement behaviors; Glycemic control

Outcome Measures

Primary Outcomes (3)

• 24-hour movement behaviors

  All the movement behaviors performed within one day (i.e. PA, SB and sleep) will be objectively measured using an Actigraph wGT3X-BT accelerometer. The participants will wear the accelerometer for 14 consecutive days. At daytime, the accelerometer will be worn at the right hip, at night the accelerometer will be switched to the non-dominant wrist.

  Through study completion, an average 1 year

• Coefficient of variation (in %)

  Coefficient of variation is a measure for intra-day glucose control and will be measured by the continuous glucose monitor of the participants. Raw CGM data of 14 consecutive days will be downloaded from the receiver of the participants with the programme compatible with their CGM (i.e. Libreview, Dexcom studio, Glooko).

  Through study completion, an average 1 year

• Time in range

  Time in range is a measure for intra-day glucose control and will be measured by the continuous glucose monitor of the participants. Raw CGM data of 14 consecutive days will be downloaded from the receiver of the participants with the programme compatible with their CGM (i.e. Libreview, Dexcom studio, Glooko).

  Through study completion, an average 1 year

Secondary Outcomes (20)

• Waist circumference (in cm)

  Through study completion, an average 1 year

• Hip circumference (in cm)

  Through study completion, an average 1 year

• Blood pressure (in mmHg)

  Through study completion, an average 1 year

• Advanced glycation endproducts

  Through study completion, an average 1 year

• LDL-cholesterol (in mg/dl)

  Through study completion, an average 1 year

Other Outcomes (11)

• Demographics

  Through study completion, an average 1 year

• Health-related variables

  Through study completion, an average 1 year

• Health-related quality of life

  Through study completion, an average 1 year

Study Arms (1)

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.

Behavioral: 24-hour movement behavior

Interventions

24-hour movement behavior BEHAVIORAL

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

Adults with type 1 diabetes

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A total of 150 adults (25-50 years) with T1DM will be recruited in this study. Participants will be recruited through visits at diabetologists at University hospital of Ghent and Antwerp, diabetes educators, dieticians, general practitioners and community health centres.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (2)

University Hospital Ghent

Ghent, East Flanders, 9000, Belgium

RECRUITING

University Hospital Antwerp

Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruno Lapauw, Professor

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Eveline Dirinck, Professor

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

• Marieke De Craemer, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte Bogaert, PhD

CONTACT

093323638; Lotte.Bogaert@ugent.be

Marieke De Craemer, Professor

CONTACT

09 332 52 08; Marieke.Decraemer@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 22, 2024
• Study Start: May 23, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

BE (2)