Table 1.
Primary and secondary outcomes
| Outcomes | Source of data | |
|---|---|---|
| measure | End-point | |
| Ulceration | Clinical evaluation by a trained nurse Participant’s report | Every 2 months until 12 months Any time during the 12 months |
| Adherence to daily temperature measurement | Logbook | Every 2 months until 12 months |
| Report of an alarm sign to the nurse | Nurse report | Every 2 months until 12 months |
| Report of an alarm sign in the logbook | Logbook | Every 2 months until 12 months |
| Dose-response analysis of SMS and voice messages | Automated system | Every 2 months until 12 months |
| Glycated hemoglobin | Blood sample | At 6 and 12 months |
| Sub-group analyses, in all participants | ||
| Caregiving status | Participant’s report | Every 2 months until 12 months |
| Use of insoles and/or orthopedic shoes | Participant’s report | Every 2 months until 12 months |
| Sub-group analyses, intervention arm only | ||
| Type of recipient (patient versus caregivers) | Participant’s report | Every 2 months until 12 months |