Active Breaks in People With Type 1 Diabetes (EXTOD-Active)

The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Active Breaks

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
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L33AF
    • Recruiting
    • Liverpool John Moores University
    • Contact: Matthew Cocks, PhD; Phone Number: 07540191292; Email: m.s.cocks@ljmu.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Habitual lifestyle; Participants in the control group will be asked to maintain their habitual lifestyle.
Experimental: Active breaks; Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min (16 bouts per day, equalling 48 min of walking) from 9am-5pm every day throughout the 4 week period. To improve adherence should participants miss a bout of walking they will be asked to do 6 min during the next bout.	Behavioral: Active Breaks; Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in time in target glycaemic range	flash glucose monitoring	change from baseline to final week of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycaemic variability (coefficient of variation)	flash glucose monitoring	change from baseline to final week of the intervention
Change in insulin dose	Insulin dose	change from baseline to final week of the intervention
Change in Concentration of Hba1c	HbA1c	change from baseline to post intervention (4 weeks)
Change Insulin to CHO ratio	Insulin to CHO ratio	change from baseline to post intervention (4 weeks)
Change in Anxiety and depression	The Hospital Anxiety and Depression Scale (HADS)	change from baseline to post intervention (4 weeks)
Change in Diabetes Quality of Life	Diabetes Quality of Life (DQOL) questionnaire	change from baseline to post intervention (4 weeks)
Change in Health-related quality of life	Short Form-12 Health Survey (SF-12)	change from baseline to post intervention (4 weeks)
Change in Height	Height (cm)	change from baseline to post intervention (4 weeks)
Change in weight	weight (kg)	change from baseline to post intervention (4 weeks)
Change in BMI	BMI	change from baseline to post intervention (4 weeks)
Change in waist circumference	waist circumference (cm)	change from baseline to post intervention (4 weeks)
Change in triglycerides.	triglycerides.	change from baseline to post intervention (4 weeks)
Change in Insulin Sensitivity Score	LogeIS	change from baseline to post intervention (4 weeks)
c-peptide	c-peptide	baseline
Change in sedentary behaviour	minutes of sitting	change from baseline to final week of the intervention
Change in carbohydrate intake	carbohydrate intake	change from baseline to final week of the intervention

Collaborators and Investigators

• Sponsor: Liverpool John Moores University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 22LJMUSPONSOR010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No