Table 1 Overview of the effectiveness measures
Measure | Means of collection | Timing of collection | Source of data |
|---|---|---|---|
Multiple risk factor control (HbA1c < 7% and BP < 130/80 mmHg or LDLc< 100 mg/dl) | Blood test + BP measurement using digital BP monitor | Baseline: Prior to intervention deliveryFollow-up: Annual visits post intervention delivery | Trial eCRF (Form C, E, F) |
Single risk factor control | |||
 HbA1c (1% point reduction) | Fasting blood test | Baseline: Prior to intervention deliveryFollow-up: Annual visits post intervention delivery | Trial eCRF (Form C, E, F) |
 SBP (5 mmHg reduction) | BP measurement using digital BP monitor (Omron-T9P) | Baseline: Prior to intervention deliveryFollow-up: Annual visits post intervention delivery | Trial eCRF (Form C, E, F) |
 DBP (5 mmHg reduction) | BP measurement using digital BP monitor (Omron-T9P) | Baseline: Prior to intervention deliveryFollow-up: Annual visits post intervention delivery | Trial eCRF (Form C, E, F) |
 LDLc (10 mg/dl reduction) | Fasting blood test | Baseline: Prior to intervention deliveryFollow-up: Annual visits post intervention delivery | Trial eCRF (Form C, E, F) |
 Major adverse cardiovascular events | Self-reported by patient and physician verified | Follow-up: All study related and non-study related clinic visits | Trial eCRF (form X) |
 Diabetes related micro-vascular complications | Self-reported by patient and physician verified | Follow-up: All study related and non-study related clinic visits | Trial eCRF (form X) |
 Quality adjusted life years | EQ5D-3 L | Baseline: Prior to intervention deliveryFollow-up: Annual visits post intervention delivery | Trial eCRF (Form C, E, F) |