Table 2.
Summary of outcome measures
| Outcomes | Time pointa | Measurement/definition |
|---|---|---|
| Primary outcome measures | ||
| Change in HbA1c | At 12 months | Measured using whole blood sample collected in EDTA tube (2 ml minimum) using Variant Turbo Ion Exchange HPLC. Participants will either have a blood sample taken by the research nurse, or will be provided with a laboratory request form for an HbA1c blood test that will be taken as per usual processes within a week of the assessment period. |
| Change in weight | At 12 months | Measured in kilograms using calibrated digital scales and standardised methods |
| Secondary outcome measures | ||
| Change in HbA1c | At 4 months | Measured using whole blood sample collected in EDTA tube (2 ml minimum) using Variant Turbo Ion Exchange HPLC (as above) |
| Change in weight | At 4 months | Measured in kilograms using calibrated digital scales and standardised methods |
| Change in waist circumference | At 4 and 12 months | Measured in millimetres using tape measure using standardised methods |
| Change in blood pressure | At 4 and 12 months | Measured using a calibrated syphgmomanometer using a standard approach (blood pressure taken when participant has been sitting quietly for 5 min, without eating, drinking or smoking. They will be asked to have feet flat on the floor, with their back up against the back of the chair, and their left arm straight on the table). Three measures will be taken with the lowest of the last two measures recorded |
| Change in self-management | At 4 and 12 months | Measured using the Partners in Health Scale [37] |
| Change of score in diabetic-specific behaviours and outcomes | At 4 and 12 months | Measured using the Summary of Diabetes Self-Care Activities tool, which assess participants’ self-care activities [38] |
| Health-related quality of life | At 4 and 12 months | Measured using the five-level EuroQol five dimensions questionnaire (EQ-5D-5 L) |
| Change in score of diabetes-specific outcomes | At 4 and 12 months | Measured using the Diabetes Distress Scale [39] |
| Change in dose of insulin | At 4 months relative to baseline, and 12 months relative to 4 months | Categorised as (1) starting insulin in current time period; (2) increasing dose of insulin in current period; (3) reducing dose of insulin in current period or (4) stopping insulin in current period. Data will be collected from patients, verified where possible from clinic records |
| Change in dose of metformin | At 4 months relative to baseline, and 12 months relative to 4 months | Categorised as (1) starting metformin in current time period; (2) increasing dose of metformin in current period; (3) reducing dose of metformin in current period or (4) stopping metformin in current period. Data will be collected from patients, verified where possible from clinic records |
| Change in dose of other oral hypoglycaemic agents (not metformin) | At 4 months relative to baseline, and 12 months relative to 4 months | Categorised as (1) starting oral hypoglycaemic agents in current time period; (2) increasing dose of oral hypoglycaemic agents in current period; (3) reducing dose of oral hypoglycaemic agents in current period or (4) stopping oral hypoglycaemic agents in current period. Data will be collected from patients, verified where possible from clinic records |
EDTA ethylenediaminetetracetic acid, HbA1c glycosylated haemoglobin, HPLC high-performance liquid chromatography
aAll time periods are time after recruitment, and compared with baseline with exception of changes in medication dose specified above