de Wit 2018.

Study characteristics
Methods	Cost‐effectiveness of the psycho‐educational blended (group and online) intervention HypoAware compared with usual care for people with type 1 and insulin‐treated type 2 diabetes with problematic hypoglycaemia: analyses of a cluster‐randomized controlled trial Clustered RCT (8 clusters and 2 to 3 diabetes healthcare professionals per cluster providers), conducted in 1) 8 self‐selected outpatient diabetes clinics in the Netherlands, 2) 2 or 3 diabetes healthcare professionals per hospital (18 diabetes nurses, 7 medical psychologists and 2 diabetes dieticians). In The Netherlands. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (HypoAware) (intervention arm)
Participants	Control arm N: 66 Intervention arm N: 71, NA, NA Diabetes type: 3 Mean age: 52.03 ± 11.84 % Male: 53.93 Longest follow‐up: 6 months
Interventions	Control arm: (usual care) Intervention arm: (HypoAware) 1) Electronic patient registry 2) Patient education 3) Promotion of self‐management
Outcomes	Harms
Funding source	This study was funded by ZonMw (837001406), the Dutch Organization for Health Research and Development and unrestricted co‐funding from Novo Nordisk, Agis Achmea and VU University Medical Centre. All had no further involvement in the study.
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random allocation performed by 2 members of the study team, who randomly select notes from 2 opaque envelopes, one with the 8 names of the clinics and one with 4 notes with ‘intervention’ and 4 notes with ‘control’.
Allocation concealment (selection bias)	Low risk	Cluster‐randomisation was carried out prior to recruitment of participants at the level of the participating clinics to avoid contamination between treatment groups within the clinics. randomly select notes from 2 opaque envelopes, one with the 8 names of the clinics and one with 4 notes with ‘intervention’ and 4 notes with ‘control’.
Provider's baseline characteristics (selection bias)	Unclear risk	Not reported.
Patient's baseline characteristics (selection bias)	Unclear risk	Table 1. Education levels look to be different, all other characteristics balanced.
Patient's baseline outcomes (selection bias)	Low risk	Table 1. Outcomes look balanced.
Incomplete outcome data (attrition bias)	High risk	Not reported. We have no records of the number of participants invited. Baseline measurement was completed by 137 participants (Table 1): 66 participants (48%) in the control group and 71 participants (52%) in the intervention group.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	High risk	Self‐report of harms.
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol with same outcomes.
Risk of contamination (other bias)	Low risk	Cluster‐randomised.
Other bias	Low risk	None identified.