Wakefield 2014.

Study characteristics
Methods	Effect of home telemonitoring on glycemic and blood pressure control in primary care clinic patients with diabetes RCT (NA clusters and NA providers), conducted in 1) Primary care clinics. The study took place at 6 University of Missouri Family Medicine (FM) and General Internal Medicine (GIM) clinics. 2) Intervention delivered by clinic nurses, advanced practice nurses and providers using an home telemonitoring system. In United States of America. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (home telemonitoring) (intervention arm)
Participants	Control arm N: 55 Intervention arm N: 53, NA, NA Diabetes type: 2 Mean age: 60.14 ± 9.72 % Male: 44.44 Longest follow‐up: 6 months
Interventions	Control arm: (usual care) 1) Promotion of self‐management Intervention arm: (home telemonitoring) 1) Case management 2) Team change 3) Electronic patient registry 4) Facilitated relay of clinical information 5) Promotion of self‐management
Outcomes	Glycated haemoglobin Systolic blood pressure
Funding source	This work was supported in part by grant number R18HS017035 from the Agency for Healthcare Research and Quality
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not reported. After patients signed the study consent form, they were randomised to intervention and control groups by the research assistant using sequentially numbered, sealed, opaque envelopes prepared in advance by the study data manager.
Allocation concealment (selection bias)	Low risk	After patients signed the study consent form, they were randomised to intervention and control groups by the research assistant using sequentially numbered, sealed, opaque envelopes prepared in advance by the study data manager.
Patient's baseline characteristics (selection bias)	Low risk	The mean age of the sample was 60 years and was significantly different between the 2 groups (control group, mean = 62.5 years, SD = 10.9, range = 32 to 92; intervention group, mean = 57.7 years, SD = 10.8, range = 29 to 82; P = 0.02). There were no significant differences in the remaining demographic variables (Table 1).
Patient's baseline outcomes (selection bias)	Low risk	Table 2. There were no baseline differences for mean A1c or SBP, although SBP differed by gender.
Incomplete outcome data (attrition bias)	High risk	They lost 12/55 patients in the control group (22%) and 13/53 in the intervention group (25%). The overall dropout/lost to follow‐up rate was 23% (2 controls and 8 intervention patients dropped out; 10 control and 4 intervention patients were lost to follow‐up). High numbers and unbalanced reasons.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Primary outcomes were objectively measured (HbA1c and BP).
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol. They stratified blood pressure analysis by gender (Quote: "There were no baseline differences for mean A1c or SBP, although SBP differed by gender"). They did not report the secondary outcomes listed in the protocol (Changes in care process and Patient‐entered device data).
Risk of contamination (other bias)	Low risk	Patient‐randomised. Unlikely that control patients used the home telemonitoring system.
Other bias	Low risk	No evidence of other bias.