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.
Study Type
OBSERVATIONAL
Enrollment
150
Cross-sectional observational study investigating the 24-hour movement behaviors and glucose control
University Hospital Ghent
Ghent, East Flanders, Belgium
RECRUITINGUniversity Hospital Antwerp
Antwerp, Belgium
RECRUITING24-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.
Time frame: 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).
Time frame: 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).
Time frame: Through study completion, an average 1 year
Waist circumference (in cm)
Waist circumference will be measured twice with a measuring tape (Seca 201).
Time frame: Through study completion, an average 1 year
Hip circumference (in cm)
Hip circumference will be measured twice with a measuring tape (Seca 201).
Time frame: Through study completion, an average 1 year
Blood pressure (in mmHg)
Blood pressure will be measured twice with an interval of one minute with an automatic OMRON M6 Comfort device after 10 minutes of rest.
Time frame: Through study completion, an average 1 year
Advanced glycation endproducts
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).
Time frame: Through study completion, an average 1 year
LDL-cholesterol (in mg/dl)
LDL-cholesterol will be obtained through the participants' most recent blood results.
Time frame: Through study completion, an average 1 year
HDL-cholesterol (in mg/dl)
HDL-cholesterol will be obtained through the participants' most recent blood results.
Time frame: Through study completion, an average 1 year
Triglycerides (in mg/dl)
Triglycerides will be obtained through the participants' most recent blood results.
Time frame: Through study completion, an average 1 year
Total cholesterol (in mg/dl)
Total cholesterol will be obtained through the participants' most recent blood results.
Time frame: Through study completion, an average 1 year
Long-term glucose regulation (in % or mmol/mol)
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.
Time frame: Through study completion, an average 1 year
Medication intake
Information about medication intake will be collected through the patient file.
Time frame: Through study completion, an average 1 year
C-peptide level
Information about C-peptide level will be collected through the patient file.
Time frame: Through study completion, an average 1 year
Co-morbidities
Information about comorbidities will be collected through the patient file.
Time frame: Through study completion, an average 1 year
Weight (in kg)
Weight will be collected through the patient file.
Time frame: Through study completion, an average 1 year
Mean glucose
The mean glucose of 14 consecutive days will be derived from the participant's raw CGM data.
Time frame: Through study completion, an average 1 year
Standard deviation
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.
Time frame: Through study completion, an average 1 year
Mean amplitude of glycemic excursions
Mean amplitude of glycemic excursions, a glucose variability metric, will be derived from the participant's raw CGM data.
Time frame: Through study completion, an average 1 year
Continuous overall net glycemic action
Continuous overall net glycemic action, a measure of glycemic variability, will be derived from the participant's raw CGM data.
Time frame: Through study completion, an average 1 year
Percent of measurements below 70 mg/dl (in %)
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.
Time frame: Through study completion, an average 1 year
Percent of measurements above 180 mg/dl (in %)
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.
Time frame: Through study completion, an average 1 year
Mean of daily differences
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.
Time frame: Through study completion, an average 1 year
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