Table 3. DFU incidence and effect of the intervention by a priori defined sub-groups.

	DFU incidence		Effect estimate *
	Control arm	Intervention arm
	n/N (%)	n/N (%)	HR (95% CI)
Among those who had a caregiver
Crude	6/31 (19.4)	7/31 (22.6)	1.11 (0.37 – 3.32)
Adjusted by site and previous foot ulceration			0.43 (0.13 – 1.48)
Among those who did not had a caregiver
Crude	3/48 (6.3)	12/48 (25.0)	4.13 (1.16 – 14.63)
Adjusted by site and previous foot ulceration			3.34 (0.94 – 11.92)

* HRs were calculated among the 169 participants that had at least one follow-up evaluation during the 18-month study period. All effect estimates were calculated using the thermometry-only arm as the reference group

DFU, diabetic foot ulcer; CI, confidence interval; HR, hazard ratio.