Kulzer 2018.

Study characteristics
Methods	Integrated personalized diabetes management improves glycemic control in patients with insulin‐treated type 2 diabetes: Results of the PDM‐ProValue study program Clustered RCT (101 clusters and NR providers), conducted in 1) General practitioner (GP) practices and diabetes specialist practitioner (DSP) practices across Germany 2) GP and diabetes specialists in Germany 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (iPDM‐Integrated personalised diabetes management) (intervention arm)
Participants	Control arm N: 494 Intervention arm N: 475, NA, NA Diabetes type: 2 Mean age: 64.71 ± 8.3 % Male: 58.13 Longest follow‐up: 12 months
Interventions	Control arm: (usual care) Intervention arm: (iPDM ‐ integrated personalised diabetes management) 1) Electronic patient registry 2) Clinician education 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management
Outcomes	Glycated haemoglobin Harms
Funding source	This work was supported by funding from Roche Diabetes Care Deutschland GmbH, Germany
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	GP and DSP practices were randomly assigned (by means of centralised permuted‐block randomisation) to the intervention group (iPDM) or the control group (CNL).
Allocation concealment (selection bias)	Low risk	Cluster trial ‐ GP and DSP practices were randomly assigned.
Provider's baseline characteristics (selection bias)	High risk	Not reported.
Patient's baseline characteristics (selection bias)	Low risk	Most characteristics are balanced.
Patient's baseline outcomes (selection bias)	Low risk	Data looks balanced.
Incomplete outcome data (attrition bias)	Low risk	50/494 (10%) discontinued from control group, 56/475 (12%) discontinued from intervention group; 27/494 (5%) in control group not included in analysis, 35/475 (7%) in intervention group. Reasons provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	All measurements were performed by a central laboratory.
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol, primary outcomes match, however secondary outcomes in protocol are vague ("effects of integrated Personalized Diabetes Management").
Risk of contamination (other bias)	Low risk	Cluster at the clinic level.
Other bias	Low risk	No evidence of other risk of bias.