Diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Randomisation
Once participants have provided informed consent, they will be randomised at the level of the individual in a 1:1 ratio to receive either the intervention or be in the usual care waitlis
Sponsors
Milton Keynes Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged > = 18 years. 2. Diagnosis of type 2 diabetes (based on WHO criteria e.g., HbA1c > = 48 mmol/mol or 6.5%) 3. Time since their last HbA1c measure: less than three months 4. Able to provide informed consent. 5. Own and use a mobile phone capable of hosting the EXi app (i.e., Apple iOS 14.3 or above) 6. Agreement that the study team can notify their healthcare practitioner of their involvement in the study (if applicable). 7. Physically mobile/able to be physically active 8. MK resident and registered with an MK GP or the MK Integrated Diabetes Services
Exclusion criteria
Exclusion criteria: 1. Unable to understand English sufficiently to complete the trial assessments. 2. Women known to be pregnant or breastfeeding 3. Do not own/ cannot operate a smartphone. 4. Life-limiting condition. 5. Chronic health conditions significantly affecting mobility. 6. Meeting physical activity guidelines of 150 minutes of moderate-to-vigorous physical activity as measured by the physical activity vital signs questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %HbA1c measured by blood test at 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of Life as measured by EQ-5D-5L at 12 months. 2. Composite endpoint of HbA1c reduction >0.5% + weight loss >3% and SBP reduction >3mmHg at 12 months measured during the participants NHS Annual Diabetes Check 3. Composite endpoint of HbA1c reduction >0.5% + weight loss >3% and SBP reduction >3mmHg measured during the participants NHS Annual Diabetes Check pre and post-intervention delivery in the waitlist usual care group. 4. Other blood biomarkers including blood lipid panel, blood glucose, and kidney function tests at 12 months. 5. Healthcare utilisation (visits to primary or secondary healthcare) measured using a modified version of the Client Services Receipt Inventory as well as linkage to NHS healthcare records via systmone at 12 months. 6. Diabetes medication used measured using a modified version of the Client Services Receipt Inventory as well as linkage to NHS healthcare records via systmone at 12 months. 7. Problem Areas in Diabetes Score / EQ-5D-5L scores at 12 months. 8. Changes in physical activity (Total physical activity, MVPA, Light physical activity, minutes sedentary) over the intervention period as measured by the Apple watch | — |
Countries
United Kingdom
Contacts
Public ContactTrial team -
Outcome results
None listed