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NCT05706298 | RECRUITING | Type 1 Diabetes

Active Breaks in People With Type 1 Diabetes
Sponsor:

Liverpool John Moores University

Brief Summary:

the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.

Condition or disease

Type 1 Diabetes

Intervention/treatment

Active Breaks

Phase

NA

Detailed Description:

An open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. Interstitial glucose concentrations (fGM), insulin dose and physical activity/ postural transitions (ActivPAL) will be monitored throughout. To improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.

Study Type : INTERVENTIONAL
Estimated Enrollment : 118 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes
Actual Study Start Date : 2022-12-07
Estimated Primary Completion Date : 2024-08-01
Estimated Study Completion Date : 2024-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 66 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * T1D diagnosis more than 3 years ago
  • * Sedentary (\> 10h per waking day sedentary (sitting or lying)
  • * Using insulin therapy with multiple daily injections or insulin pump
  • * Aged 18-66 (UK retirement age)
  • * Use of Abbot FreeStyle Libre 2 fGM (\>6 weeks to avoid potential lifestyle changes as a result of sensor use)
Exclusion Criteria
  • * Engaged in structured planned exercise (e.g. running, cycling, gym, or sports)
  • * Pregnancy or planning to become pregnant
  • * \<6 months postpartum or stopped breastfeeding \<1 month before recruitment
  • * Existing cerebrovascular or cardiovascular disease
  • * Significant history of hyperglycaemia (HbA1c \>85 mmol/mol)
  • * History of severe hypoglycaemia requiring third party assistance within the last 3 months
Active Breaks in People With Type 1 Diabetes

Location Details

NCT05706298

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How to Participate

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Locations

RECRUITING

United Kingdom,

Liverpool John Moores University

Liverpool, United Kingdom, Sorry