Actively Recruiting

Age: 25Years - 50Years
All Genders
NCT06425640

24-hour Movement Behaviors in Adults With Type 1 Diabetes

Led by University Hospital, Ghent · Updated on 2024-06-06

150

Participants Needed

2

Research Sites

79 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

U

University Ghent

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

24-hour Movement Behaviors in Adults With Type 1 Diabetes

Who Can Participate

Age: 25Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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%
Not Eligible

You will not qualify if you...

  • Using a hybrid closed loop insulin pump
  • Shift workers
  • Known cardiovascular disease such as peripheral arterial disease limiting walking to under 500 meters, past strokes affecting motor function, or severe heart failure (NYHA class 3 or 4)
  • Physical disabilities affecting daily function like amputations or paralysis
  • Conditions impacting normal movement behaviors including active cancer treatment, advanced diabetic nephropathy, severe chronic obstructive pulmonary disease, or severe asthma
  • Visual impairments such as severe retinopathy leading to blindness
  • Hypoglycemia unawareness
  • Symptomatic peripheral neuropathy with symptoms like pain, loss of sensation, or ulcers
  • Professional or semi-professional top athletes
  • Participation in another supervised healthy lifestyle or drug intervention

AI-Screening

AI-Powered Screening

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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

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Research Team

L

Lotte Bogaert, PhD

CONTACT

M

Marieke De Craemer, Professor

CONTACT

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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24-hour Movement Behaviors in Adults With Type 1 Diabetes | DecenTrialz