Dinneen 2013.

Study characteristics
Methods	Group follow‐up compared to individual clinic visits after structured education for type 1 diabetes: a cluster randomised controlled trial Clustered RCT (6 clusters and NR providers), conducted in 1) Study participants were recruited from waiting lists of individuals who had expressed an interest in receiving DAFNE training in participating centres. Trial involving patients attending hospital diabetes clinics in Ireland. Intervention delivered in 6 clinics delivering outpatient diabetes care on the island of Ireland (in the Republic and Northern Ireland). 2) Intervention provided by trained doctors and diabetes educators. In Ireland. 2 arms: 1. Control (individual clinic visits) (control arm) and 2. Intervention (booster group follow‐up) (intervention arm)
Participants	Control arm N: 221 Intervention arm N: 216, NA, NA Diabetes type: 1 Mean age: 40.8 ± 10.2 % Male: 46.2 Longest follow‐up: 18 months
Interventions	Control arm: (individual clinic visits) 1) Patient education 2) Promotion of self‐management Intervention arm: (booster group follow‐up) 1) Case management 2) Patient education 3) Promotion of self‐management
Outcomes	Glycated haemoglobin Harms
Funding source	Health Research Board, Ireland, Health Services Research and Development Award. This study was supported by the Health Research Board through a Health Services Research award (HS‐2005‐25). Meetings of the study steering group and 3 annual meetings of the Irish DAFNE Study team were funded by Novo Nordisk Ireland.
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation (by a computer‐generated numbers list) was undertaken by an independent statistician.
Allocation concealment (selection bias)	Low risk	Clustered‐RCT. Randomisation was undertaken by an independent statistician.
Provider's baseline characteristics (selection bias)	Unclear risk	Supplementary Table 1 provides baseline characteristics of participating centres, but we do not know to which arm was assigned each centres.
Patient's baseline characteristics (selection bias)	Low risk	Table 1. Characteristics look balanced between groups.
Patient's baseline outcomes (selection bias)	Low risk	Table 1. Outcomes balanced between groups.
Incomplete outcome data (attrition bias)	High risk	At 18 months (figure 1), they have HbA1c data for 150 out of 216 patients randomised in the intervention arm (30.6% lost) and 169/221 in the control arm (23.5% lost). High and unbalanced numbers. Missing data were greater than expected.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Unclear risk	Objective (HbA1c) and subjective outcomes (self‐reported hypoglycaemia, but secondary outcome).
Selective reporting (reporting bias)	High risk	Prospectively registered protocol. Secondary outcomes included weight, blood pressure, lipid levels and rates of severe hypoglycaemia. Likewise no significant change was seen over time in blood pressure or lipid levels (data not shown). Many secondary outcomes were added to the protocol after the end of patient recruitment.
Risk of contamination (other bias)	Low risk	Clustered RCT, but all participants received DAFNE at baseline (involves patient education and promotion of self‐management).
Other bias	Low risk	No evidence of other bias.