24-hour Movement Behaviors in Adults With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Behavioral: 24-hour movement behavior
- Registration Number
- NCT06425640
- Lead Sponsor
- University Hospital, Ghent
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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%
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adults with type 1 diabetes 24-hour movement behavior 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.
- Primary Outcome Measures
Name Time Method Coefficient of variation (in %) Through study completion, an average 1 year 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).
Time in range Through study completion, an average 1 year 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).
24-hour movement behaviors Through study completion, an average 1 year 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.
- Secondary Outcome Measures
Name Time Method LDL-cholesterol (in mg/dl) Through study completion, an average 1 year LDL-cholesterol will be obtained through the participants' most recent blood results.
Medication intake Through study completion, an average 1 year Information about medication intake will be collected through the patient file.
Mean glucose Through study completion, an average 1 year The mean glucose of 14 consecutive days will be derived from the participant's raw CGM data.
Continuous overall net glycemic action Through study completion, an average 1 year Continuous overall net glycemic action, a measure of glycemic variability, will be derived from the participant's raw CGM data.
Mean of daily differences Through study completion, an average 1 year Mean of daily differences, a measure that gives insight in the between-days glycemic variability, will be derived from the participant's raw CGM data.
Hip circumference (in cm) Through study completion, an average 1 year Hip circumference will be measured twice with a measuring tape (Seca 201).
Blood pressure (in mmHg) Through study completion, an average 1 year Blood pressure will be measured twice with an interval of one minute with an automatic OMRON M6 Comfort device after 10 minutes of rest.
Waist circumference (in cm) Through study completion, an average 1 year Waist circumference will be measured twice with a measuring tape (Seca 201).
Advanced glycation endproducts Through study completion, an average 1 year AGE's, a predictive value for the development of diabetic and cardiovascular complications, will be measured with a skin AGE-reader (Diagnoptics Technologies, Groningen, the Netherlands).
Total cholesterol (in mg/dl) Through study completion, an average 1 year Total cholesterol will be obtained through the participants' most recent blood results.
C-peptide level Through study completion, an average 1 year Information about C-peptide level will be collected through the patient file.
Percent of measurements above 180 mg/dl (in %) Through study completion, an average 1 year Percent of measurements above 180 mg/dl, a measure that gives insight in the time in hyperglycemia, will be derived from the participant's raw CGM data.
HDL-cholesterol (in mg/dl) Through study completion, an average 1 year HDL-cholesterol will be obtained through the participants' most recent blood results.
Long-term glucose regulation (in % or mmol/mol) Through study completion, an average 1 year Average HbA1c over the last 10 years (or from diagnosis if diagnosis was less than 10 years ago) will be collected through the patient file.
Triglycerides (in mg/dl) Through study completion, an average 1 year Triglycerides will be obtained through the participants' most recent blood results.
Weight (in kg) Through study completion, an average 1 year Weight will be collected through the patient file.
Co-morbidities Through study completion, an average 1 year Information about comorbidities will be collected through the patient file.
Standard deviation Through study completion, an average 1 year The standard deviation of glucose, a measure of the spread in glucose readings around the average glucose, will be derived from the participant's raw CGM data.
Mean amplitude of glycemic excursions Through study completion, an average 1 year Mean amplitude of glycemic excursions, a glucose variability metric, will be derived from the participant's raw CGM data.
Percent of measurements below 70 mg/dl (in %) Through study completion, an average 1 year Percent of measurements below 70 mg/dl, a measure that gives insight in the time in hypoglycemia, will be derived from the participant's raw CGM data.
Trial Locations
- Locations (2)
University Hospital Antwerp
🇧🇪Antwerp, Belgium
University Hospital Ghent
🇧🇪Ghent, East Flanders, Belgium