Active Breaks in People With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Active Breaks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Habitual lifestyle<br>Participants in the control group will be asked to maintain their habitual lifestyle. | |
| Experimental: Active breaks<br>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<br>* Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm<br>|

What is the study measuring?
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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 |