Table 2 Primary and secondary outcome measures

Primary

The difference in function after 2 years of follow-up between intervention and usual care groups, according to changes in summary ordinal score on the SPPB test ≥1 [26].

Secondary

a) Barthel ADL index [13] and b) Lawton IADL scale [27].

c) Quality of life, as measured by using the EuroQoL index, EQ-5D-5 L [28].

d) Economic costs/health care expenditure due to diabetes and its impact on disability and quality of life, using an economic model embracing the direct health-related costs (in-subject, out-subject, pharmaceutical), formal care costs (home care, respite care, day centres), and the informal care costs (carer).

e) Episodes of symptomatic hypoglycaemia (that is, a recorded blood sugar <4 mmol/L, or symptoms or signs attributed to low blood sugar and responding to appropriate treatment).

f) Episodes of hospital admission (that is, any admission involving an overnight stay).

g) Episodes of permanent institutionalisation (that is, permanent move to any care setting other than the subject’s own home, where paid staff are available to provide care if needed at any time during the day or night).

h) Burden of the carer, as assessed by the Modified Caregiver Strain Index (MCSI) [29].

i) Mortality.