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Clinical Trial NCT06425640 (24h-MBs_T1D) for Diabetes Mellitus, Type 1 is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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24-hour Movement Behaviors in Adults With Type 1 Diabetes (24h-MBs_T1D) 150 Lifestyle
Clinical Trial NCT06425640 (24h-MBs_T1D) is an observational study for Diabetes Mellitus, Type 1 that is recruiting. It started on 23 May 2024 with plans to enroll 150 participants. Led by University Hospital, Ghent, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 6 June 2024.
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 g...Show More
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.
Conditions
Diabetes Mellitus, Type 1Other Study IDs
- 24h-MBs_T1D
- ONZ-2023-0611
NCT ID Number
Start Date (Actual)
2024-05-23
Last Update Posted
2024-06-06
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
150
Study Type
Observational
Status
Recruiting
Keywords
24-hour movement behaviors
Glycemic control
Glycemic control
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 Cross-sectional observational study investigating the 24-hour movement behaviors and glucose control |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Waist circumference (in cm) | Waist circumference will be measured twice with a measuring tape (Seca 201). | Through study completion, an average 1 year |
Hip circumference (in cm) | Hip circumference will be measured twice with a measuring tape (Seca 201). | 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. | 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). | Through study completion, an average 1 year |
LDL-cholesterol (in mg/dl) | LDL-cholesterol will be obtained through the participants' most recent blood results. | Through study completion, an average 1 year |
HDL-cholesterol (in mg/dl) | HDL-cholesterol will be obtained through the participants' most recent blood results. | Through study completion, an average 1 year |
Triglycerides (in mg/dl) | Triglycerides will be obtained through the participants' most recent blood results. | Through study completion, an average 1 year |
Total cholesterol (in mg/dl) | Total cholesterol will be obtained through the participants' most recent blood results. | 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. | Through study completion, an average 1 year |
Medication intake | Information about medication intake will be collected through the patient file. | Through study completion, an average 1 year |
C-peptide level | Information about C-peptide level will be collected through the patient file. | Through study completion, an average 1 year |
Co-morbidities | Information about comorbidities will be collected through the patient file. | Through study completion, an average 1 year |
Weight (in kg) | Weight will be collected through the patient file. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, an average 1 year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
25 Years
Eligible Sexes
All
- 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
University Hospital, GhentUniversity Ghent282 active studies to exploreStudy Central Contact
Contact: Lotte Bogaert, PhD, 093323638, [email protected]
Contact: Marieke De Craemer, Professor, 09 332 52 08, [email protected]
2 Study Locations in 1 Countries
East Flanders
University Hospital Ghent, Ghent, East Flanders, 9000, Belgium
Bruno Lapauw, Professor, Contact
Recruiting
University Hospital Antwerp, Antwerp, 2650, Belgium
Eveline Dirinck, Professor, Contact
Recruiting