Trials
Search / Trial NCT06425640

24-hour Movement Behaviors in Adults With Type 1 Diabetes

Launched by UNIVERSITY HOSPITAL, GHENT · May 17, 2024

Trial Information

Current as of February 18, 2025

Recruiting

Keywords

24 Hour Movement Behaviors Glycemic Control

ClinConnect Summary

This clinical trial is studying the daily habits of adults aged 25 to 50 with type 1 diabetes to see how their physical activity, sleep, and time spent sitting affect their blood sugar control. The goal is to understand how combining these daily behaviors influences their overall health and diabetes management. Researchers will track the movement and glucose levels of 150 participants over two weeks using special devices, while also collecting information about their health through questionnaires and measurements at a clinic.

To participate in this study, individuals must be diagnosed with type 1 diabetes for at least two years, use a continuous glucose monitor, and have a certain range of blood sugar control. Those who are shift workers, have certain medical conditions, or use specific types of insulin pumps will not be eligible. Participants can expect to wear an activity tracker and provide information about their daily routines, which will help improve future diabetes care and support.

Gender

ALL

Eligibility 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

Trial Officials

Bruno Lapauw, Professor

Principal Investigator

University Hospital, Ghent

Eveline Dirinck, Professor

Principal Investigator

University Hospital, Antwerp

Marieke De Craemer, Professor

Principal Investigator

University Ghent

About University Hospital, Ghent

University Hospital Ghent is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. Located in Ghent, Belgium, the hospital is affiliated with Ghent University, fostering a collaborative environment that integrates cutting-edge medical research with high-quality patient care. With a diverse range of specialized departments and a dedicated team of researchers and clinicians, University Hospital Ghent is at the forefront of developing new therapies and improving treatment protocols, aiming to enhance patient outcomes and contribute to the global medical community.

Locations

Antwerp, , Belgium

Ghent, East Flanders, Belgium

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0