Can a remotely monitored, home-based exercise intervention for individuals with type-one diabetes reduce immune driven disease activity? (EXTOD-Immune)
- Queen Elizabeth Hospital, University Hospitals Birmingham
- Musgrove Park Hospital, Somerset NHS Foundation Trust
- School of Sport and Exercise Sciences, Liverpool John Moores University
- Royal Free London NHS Foundation Trust
The project is for patients with type-1 diabetes (diagnosed within 3 years) who are not physically active. Patients will be asked to undertake an exercise intervention for 12 weeks in their own home, followed by a 12-week break and then a 12-week control period with no prescribed exercise.
The aim of this project is to investigate the impact of a remotely monitored exercise intervention on immune driven disease activity in patients with a recent diagnosis of type-1 diabetes vs. standard care with no prescribed exercise.
Eligibility to take part
- Age: >18 years old
- Clinical diagnosis of T1D made within the last 3 years
- Self‐administering their insulin as part of a multiple dose injection regime or insulin pump therapy.
- Both participant and physician feel that they are able to exercise safely.
- Patient is able to estimate carbohydrate content of meals
- Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly
- Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L
- Uncontrolled blood pressure
- Pregnancy or planning pregnancy
- Adhering to the current recommended physical activity guidelines (> 150 minutes)
- Additional health conditions that might put the participant at risk for this study e.g. heart disease, diabetic complication or a history of severe hypoglycaemia requiring third party assistance within the last 3 months.
- Unable to provide full informed consent.
If you are interested in taking part, please click the “Get Involved” button below:
What will I be asked to do?
If you agree to take part in the study and meet the inclusion criteria after our initial screening (conducted remotely, including a saliva sample), you will be invited to attend your local Clinical Research Facility (CRF) on four separate occasions over a 36-week period. On each visit, we will carry out a medical review and measure your weight, blood pressure, pulse and draw a blood sample. We will also ask you to wear a continuous glucose monitor for 2 weeks. You will then be randomly allocated to either a home-based exercise or control group (undertake your usual level of exercise without any extra support from us) between weeks 1-12. Following a 12-week break from the study, you will be allocated to the other group in weeks 24-36. Please see a simplified study schematic below:
The exercise is safe for people with type-1 diabetes to undertake at home. Details are outlined below:
- For weeks 1-2 of the intervention, we will ask participants to:
- Perform a low intensity warm up for 2-minutes
- Perform 6 x 1-minute high intensity intervals (bodyweight exercises), interspersed with 1-minute rest intervals (11 minutes). You will be asked to exercise at an intensity that elicits 80% of your maximum heart rate.
- Total exercise time will be 13 minutes.
- For weeks 3-4 of the intervention, this will increase to 8 intervals (total exercise time will be 17 minutes).
- For weeks 5-12 of the intervention, this will increase to 10 intervals (total exercise time will be 21 minutes).
Travel expenses from study visits will be reimbursed and all participants will receive a £50 Amazon voucher when they complete the study.
Who is running this study?
Sponsor: University of Birmingham
Chief Investigator: Dr Alex Wadley
Funder: The Rosetrees Trust
Study site: Central site is University of Birmingham, but study sites available nationally