Clinical trial NCT06425640: 24-hour Movement Behaviors in Adults With Type 1 Diabetes
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Keywords: 24-hour movement behaviors
Glycemic control
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2024-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: 24-hour movement behaviors
timeFrame: Through study completion, an average 1 year
measure: Coefficient of variation (in %)
timeFrame: Through study completion, an average 1 year
measure: Time in range
timeFrame: Through study completion, an average 1 year
Secondary outcomes:
measure: Waist circumference (in cm)
timeFrame: Through study completion, an average 1 year
measure: Hip circumference (in cm)
timeFrame: Through study completion, an average 1 year
measure: Blood pressure (in mmHg)
timeFrame: Through study completion, an average 1 year
measure: Advanced glycation endproducts
timeFrame: Through study completion, an average 1 year
measure: LDL-cholesterol (in mg/dl)
timeFrame: Through study completion, an average 1 year
measure: HDL-cholesterol (in mg/dl)
timeFrame: Through study completion, an average 1 year
measure: Triglycerides (in mg/dl)
timeFrame: Through study completion, an average 1 year
measure: Total cholesterol (in mg/dl)
timeFrame: Through study completion, an average 1 year
measure: Long-term glucose regulation (in % or mmol/mol)
timeFrame: Through study completion, an average 1 year
measure: Medication intake
timeFrame: Through study completion, an average 1 year
measure: C-peptide level
timeFrame: Through study completion, an average 1 year
measure: Co-morbidities
timeFrame: Through study completion, an average 1 year
measure: Weight (in kg)
timeFrame: Through study completion, an average 1 year
measure: Mean glucose
timeFrame: Through study completion, an average 1 year
measure: Standard deviation
timeFrame: Through study completion, an average 1 year
measure: Mean amplitude of glycemic excursions
timeFrame: Through study completion, an average 1 year
measure: Continuous overall net glycemic action
timeFrame: Through study completion, an average 1 year
measure: Percent of measurements below 70 mg/dl (in %)
timeFrame: Through study completion, an average 1 year
measure: Percent of measurements above 180 mg/dl (in %)
timeFrame: Through study completion, an average 1 year
measure: Mean of daily differences
timeFrame: Through study completion, an average 1 year
Other outcomes:
measure: Demographics
timeFrame: Through study completion, an average 1 year
measure: Health-related variables
timeFrame: Through study completion, an average 1 year
measure: Health-related quality of life
timeFrame: Through study completion, an average 1 year
measure: Depression an anxiety
timeFrame: Through study completion, an average 1 year
measure: Diabetes knowledge
timeFrame: Through study completion, an average 1 year
measure: Health literacy
timeFrame: Through study completion, an average 1 year
measure: Diabetes self-management
timeFrame: Through study completion, an average 1 year
measure: Behavioral factors
timeFrame: Through study completion, an average 1 year
measure: Environmental factors
timeFrame: Through study completion, an average 1 year
measure: Context-related information about physical activity
timeFrame: Through study completion, an average 1 year
measure: Food intake
timeFrame: Through study completion, an average 1 year
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East Flanders
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital, Ghent
name: Bruno Lapauw, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Eveline Dirinck, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Marieke De Craemer, Professor
role: PRINCIPAL_INVESTIGATOR
References: