Investigating daily movement behaviors in adults with Type 1 diabetes
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.
This study looks at how daily activities, like exercise, sitting, and sleep, affect blood sugar control in adults with Type 1 diabetes to help improve their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 2 sites (Ghent, East Flanders and 1 other locations) |
| Trial ID | NCT06425640 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between 24-hour movement behaviors, including physical activity, sedentary behavior, and sleep, and glycemic control in adults aged 25 to 50 with Type 1 diabetes mellitus. By utilizing continuous glucose monitors, the study will assess how these behaviors collectively impact daily glucose levels and overall diabetes management. The research seeks to provide insights into optimizing lifestyle interventions for better glycemic outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 50 with a diagnosis of Type 1 diabetes for at least two years and who are using a continuous glucose monitor.
Not a fit: Patients using a hybrid closed loop insulin pump or those with significant physical disabilities or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing Type 1 diabetes through better lifestyle recommendations.
How similar studies have performed: While the approach of integrating multiple movement behaviors is relatively novel, similar studies have shown promising results in improving health outcomes in diabetes management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent, East Flanders and 1 other locations
- University Hospital Ghent — Ghent, East Flanders, Belgium (Recruiting)
- University Hospital Antwerp — Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Bruno Lapauw, Professor — University Hospital, Ghent
- Study coordinator: Lotte Bogaert, PhD
- Email: Lotte.Bogaert@ugent.be
- Phone: 093323638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.