Diabetes Mellitus, Type 124h-MBs_T1DNCT06425640
24-hour Movement Behaviors in Adults With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- 24-hour movement behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 2 sitesBelgium
- Study dates
- 23 May 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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%
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
University Hospital Antwerp
Antwerp, 2650
Eveline Dirinck, Professor
- Recruiting
University Hospital Ghent
Ghent, East Flanders, 9000
Bruno Lapauw, Professor
About this study
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.
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
- Being tested
- 24-hour movement behavior
- Keywords
- 24-hour movement behaviors, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour movement behaviorBehavioural
Cross-sectional observational study investigating the 24-hour movement behaviors and glucose control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 24-hour movement behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Through study completion, an average 1 year
Secondary outcomes (20)
Waist circumference (in cm)
Waist circumference will be measured twice with a measuring tape (Seca 201).
Measured: Through study completion, an average 1 year
Hip circumference (in cm)
Hip circumference will be measured twice with a measuring tape (Seca 201).
Measured: 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.
Measured: 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).
Measured: Through study completion, an average 1 year
LDL-cholesterol (in mg/dl)
LDL-cholesterol will be obtained through the participants' most recent blood results.
Measured: Through study completion, an average 1 year
HDL-cholesterol (in mg/dl)
HDL-cholesterol will be obtained through the participants' most recent blood results.
Measured: Through study completion, an average 1 year
Triglycerides (in mg/dl)
Triglycerides will be obtained through the participants' most recent blood results.
Measured: Through study completion, an average 1 year
Total cholesterol (in mg/dl)
Total cholesterol will be obtained through the participants' most recent blood results.
Measured: 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.
Measured: Through study completion, an average 1 year
Medication intake
Information about medication intake will be collected through the patient file.
Measured: Through study completion, an average 1 year
C-peptide level
Information about C-peptide level will be collected through the patient file.
Measured: Through study completion, an average 1 year
Co-morbidities
Information about comorbidities will be collected through the patient file.
Measured: Through study completion, an average 1 year
Weight (in kg)
Weight will be collected through the patient file.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start23 May 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Bruno Lapauw, Professor, Principal investigator, University Hospital, GhentEveline Dirinck, Professor, Principal investigator, University Hospital, AntwerpMarieke De Craemer, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425640
- Sponsor's protocol ID
- ONZ-2023-0611
- Acronym
- 24h-MBs_T1D
- Status last verified
- Jun 2024
- First submitted
- 1 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06425640
- Acronym / sponsor ID
- 24h-MBs_T1D / ONZ-2023-0611
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- 24-hour movement behaviors, Glycemic control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 23 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with type 1 diabetes | – | Behavioral: 24-hour movement behaviorAdults 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour movement behaviorCross-sectional observational study investigating the 24-hour movement behaviors and glucose control | Behavioural | Adults with type 1 diabetes |
Primary outcome
24-hour movement behaviors
Time frame: 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.
Coefficient of variation (in %)
Time frame: 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
Time frame: 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).
20 secondary outcomes
Waist circumference (in cm)
Time frame: Through study completion, an average 1 year
Hip circumference (in cm)
Time frame: Through study completion, an average 1 year
Blood pressure (in mmHg)
Time frame: Through study completion, an average 1 year
Advanced glycation endproducts
Time frame: Through study completion, an average 1 year
LDL-cholesterol (in mg/dl)
Time frame: Through study completion, an average 1 year
HDL-cholesterol (in mg/dl)
Time frame: Through study completion, an average 1 year
Triglycerides (in mg/dl)
Time frame: Through study completion, an average 1 year
Total cholesterol (in mg/dl)
Time frame: Through study completion, an average 1 year
Long-term glucose regulation (in % or mmol/mol)
Time frame: Through study completion, an average 1 year
Medication intake
Time frame: Through study completion, an average 1 year
C-peptide level
Time frame: Through study completion, an average 1 year
Co-morbidities
Time frame: Through study completion, an average 1 year
Weight (in kg)
Time frame: Through study completion, an average 1 year
Mean glucose
Time frame: Through study completion, an average 1 year
Standard deviation
Time frame: Through study completion, an average 1 year
Mean amplitude of glycemic excursions
Time frame: Through study completion, an average 1 year
Continuous overall net glycemic action
Time frame: Through study completion, an average 1 year
Percent of measurements below 70 mg/dl (in %)
Time frame: Through study completion, an average 1 year
Percent of measurements above 180 mg/dl (in %)
Time frame: Through study completion, an average 1 year
Mean of daily differences
Time frame: Through study completion, an average 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Lapauw, Professor principal investigator
University Hospital, Ghent
Eveline Dirinck, Professor principal investigator
University Hospital, Antwerp
Marieke De Craemer, Professor principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lotte Bogaert, PhD (093323638, Lotte.Bogaert@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour movement behaviors (time frame: Through study completion, an average 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.