Type 1 Diabetes
Conditions
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.
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.
Interventions
BEHAVIORALActive Breaks
Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm
Sponsors
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in time in target glycaemic range | change from baseline to final week of the intervention | flash glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycaemic variability (coefficient of variation) | change from baseline to final week of the intervention | flash glucose monitoring |
| Change in insulin dose | change from baseline to final week of the intervention | Insulin dose |
| Change Insulin to CHO ratio | change from baseline to post intervention (4 weeks) | Insulin to CHO ratio |
| Change in Anxiety and depression | change from baseline to post intervention (4 weeks) | The Hospital Anxiety and Depression Scale (HADS) |
| Change in Diabetes Quality of Life | change from baseline to post intervention (4 weeks) | Diabetes Quality of Life (DQOL) questionnaire |
| Change in Health-related quality of life | change from baseline to post intervention (4 weeks) | Short Form-12 Health Survey (SF-12) |
| Change in Height | change from baseline to post intervention (4 weeks) | Height (cm) |
| Change in Concentration of Hba1c | change from baseline to post intervention (4 weeks) | HbA1c |
| Change in BMI | change from baseline to post intervention (4 weeks) | BMI |
| Change in waist circumference | change from baseline to post intervention (4 weeks) | waist circumference (cm) |
| Change in triglycerides. | change from baseline to post intervention (4 weeks) | triglycerides. |
| Change in Insulin Sensitivity Score | change from baseline to post intervention (4 weeks) | LogeIS |
| c-peptide | baseline | c-peptide |
| Change in sedentary behaviour | change from baseline to final week of the intervention | minutes of sitting |
| Change in carbohydrate intake | change from baseline to final week of the intervention | carbohydrate intake |
| Change in weight | change from baseline to post intervention (4 weeks) | weight (kg) |
Countries
United Kingdom
Outcome results
None listed