George 2008.

Study characteristics
Methods	Clinical effectiveness of a brief educational intervention in Type 1 diabetes: results from the BITES (Brief Intervention in Type 1 diabetes, Education for Self‐efficacy) trial RCT (NA clusters and NA providers), conducted in 1) Participants were recruited from people with diabetes attending our specialist diabetes service in a hospital setting (secondary care setting, York Hospital, UK). 2) A specifically trained diabetes specialist nurse and a specialist diabetes dietician facilitated intervention delivery. In United Kingdom. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (brief 2.5 days psycho‐educational intervention) (intervention arm)
Participants	Control arm N: 60 Intervention arm N: 54, NA, NA Diabetes type: 1 Mean age: 41 ± 10.06 % Male: 44.74 Longest follow‐up: 12 months
Interventions	Control arm: (usual care) Intervention arm: (brief 2.5 days psycho‐educational intervention) 1) Case management 2) Patient education 3) Promotion of self‐management
Outcomes	Glycated haemoglobin Harms
Funding source	From trial register. Funder type: Government. Funder name: York NHS Trust Research and Development Innovation Fund. (UK) (Ref 01/08/016).
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported. Of the 117 patients attending randomisation, 54 were allocated to the intervention group and 60 to the control group.
Allocation concealment (selection bias)	Unclear risk	An independent evaluator then allocated participants using block randomisation (block size = 6) to intervention or control groups using sealed envelopes (opaque?) in strict ascendant order.
Patient's baseline characteristics (selection bias)	Low risk	Table 3. Characteristics of participants in the 2 groups were comparable at entry (Table 3).
Patient's baseline outcomes (selection bias)	Low risk	Table 3. Characteristics of participants in the 2 groups were comparable at entry. Lipids, blood pressure, use of insulin and BMI demonstrated no statistical significance between the 2 groups (Table 3). Unclear about HbA1c.
Incomplete outcome data (attrition bias)	High risk	At 12 months, they lost 8/60 patients in the control group (13.3%) and 4/54 in the intervention group (7.4%). Unbalanced numbers. Reasons not reported.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Unclear risk	Primary outcomes were HbA1c (objectively measured) and severe hypoglycaemia (objectively and subjectively measured). Severe hypoglycaemia was defined as a recorded episode in which the patient required assistance with treatment and either documented blood glucose < 2.7 mmol/L or detected clinical signs that required oral carbohydrate administered by a third party, subcutaneous glucagon or intravenous glucose.
Selective reporting (reporting bias)	Unclear risk	Retrospectively registered protocol. Secondary outcomes were blood pressure, weight, height, lipids and psychometric profile. No post‐intervention data are reported for blood pressure. Also, only the difference between means are reported for the other outcomes.
Risk of contamination (other bias)	Low risk	Only the intervention group had the brief (2.5 days) psycho‐educational intervention facilitated by a specifically trained diabetes specialist nurse and a specialist diabetes dietician. We made every effort to ensure that the control group received less input than the intervention group. However, principles of self‐management from the BITES course may have spilled over into the day‐to‐day practice of healthcare providers.
Other bias	Low risk	None.