Community-based type 2 diabetes care by lay village health workers in rural Lesotho: protocol for a cluster-randomized trial within the ComBaCaL cohort study (ComBaCaL T2D TwiC)

Table 3 Overview of analysis sets

	*Description*	*FBG*	*Treatment*	*Criteria for direct referral*	*HbA1c*	*Pregnancy*
Primary analysis set	Non-pregnant, uncomplicated, uncontrolled T2D, no direct referral required	≥ 7 mmol/l	No treatment or no more than one oral drug	Not met	Any	Non-pregnant
Secondary analysis set a	Non-pregnant, uncomplicated, uncontrolled T2D, no direct referral required, HbA1c ≥ 6.5%	≥ 7 mmol/l	No treatment or no more than one oral drug	Not met	≥ 6.5%	Non-pregnant
Secondary analysis set b	Non-pregnant T2D, HbA1c ≥ 6.5%	Any	Any	Any	≥ 6.5%	Non-pregnant
Secondary analysis set c	Non-pregnant T2D	Any	Any	Any	Any	Non-pregnant

Criteria for direct referral: FBG > 14 mmol/l or RBG > 16.7 mmol/l or having polyuria, polydipsia, and weight loss independent of blood glucose values
T2D type 2 diabetes, FBG fasting blood glucose, RBG random blood glucose

ISSN: 1745-6215