Actively Recruiting
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
Led by University Hospital, Ghent · Updated on 2024-06-06
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how daily movement patterns affect glucose control in adults aged 25 to 50 with type 1 diabetes mellitus (T1DM). Despite the use of continuous glucose monitors, managing blood sugar levels remains challenging, and this study focuses on the combined impact of physical activity, sedentary behavior, and sleep on glucose stability and cardiometabolic health markers. Participants will wear an Actigraph accelerometer for 14 consecutive days to track their 24-hour movement behaviors. Alongside, they will use their own continuous glucose monitor to provide daily glucose data. Additional information will be collected through an online questionnaire, a food diary, and a single visit to a study center for measurements such as blood pressure, weight, and waist and hip circumference. During the study, researchers will evaluate glucose control through measures like time in range and coefficient of variation, as well as cardiometabolic health markers including blood pressure and cholesterol levels. The study is observational and will gather data over approximately one year to inform future interventions that support healthy daily movement behaviors in adults with T1DM.
CONDITIONS
Brief Title
24-hour Movement Behaviors in Adults With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between 25 and 50 years
- Diagnosed with type 1 diabetes mellitus for at least two years
- Using a continuous glucose monitor
- Taking a minimum of 10 units of insulin daily
- Recent HbA1c levels between 6% and 9.5%
You will not qualify if you...
- Using a hybrid closed loop insulin pump
- Shift workers
- Known cardiovascular diseases affecting walking or heart function
- Physical disabilities impacting daily activities
- Conditions affecting normal movement behavior such as advanced diabetic nephropathy, severe lung diseases, or active cancer treatment
- Visual impairments like significant retinopathy causing vision loss
- Hypoglycemia unawareness
- Symptomatic peripheral neuropathy
- Professional or semi-professional top athletes
- Participation in another supervised lifestyle or drug intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants wear an accelerometer and a continuous glucose monitor to observe 24-hour movement behaviors and glucose control. They also complete an online questionnaire and food diary to provide additional information about their daily behaviors.
Periodic remote assessments and device data collection
Trial Site Locations
Total: 2 locations
1
University Hospital Ghent
Ghent, East Flanders, Belgium, 9000
Actively Recruiting
2
University Hospital Antwerp
Antwerp, Belgium, 2650
Actively Recruiting
Research Team
L
Lotte Bogaert, PhD
M
Marieke De Craemer, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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