Frias 2017.

Study characteristics
Methods	Effectiveness of digital medicines to improve clinical outcomes in patients with uncontrolled hypertension and type 2 diabetes: prospective, open‐label, cluster‐randomized pilot clinical trial Clustered RCT (16 clusters and NR providers), conducted in 1) Primary Care Clinics, California and Colorado, USA; 2) Primary Care Physician in United States of America 3 arms: 1. Control (usual care) (control arm) and 2. Intervention 1 (4‐week digital medicine offering) (intervention arm)3. Intervention 2 (12‐week digital medicine offering) (other arm)
Participants	Control arm N: 36 Intervention arm N: 41, 41, NA Diabetes type: 2 Mean age: 58.81 ± 10.08 % Male: 49.59 Longest follow‐up: 3 months
Interventions	Control arm: (usual care) 1) Patient education Intervention arm: (4‐week digital medicine offering) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management 6) Patient reminders Intervention arm: (12‐week digital medicine offering) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management 6) Patient reminders
Outcomes	Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Hypertension control
Funding source	This study was funded and supported by the sponsor, Proteus Digital Health
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details of randomisation methodology provided.
Allocation concealment (selection bias)	Low risk	Cluster‐RCT.
Provider's baseline characteristics (selection bias)	Unclear risk	Not reported.
Patient's baseline characteristics (selection bias)	Low risk	No statistically different characteristics were reported.
Patient's baseline outcomes (selection bias)	High risk	Intervention 2 (12‐week DMO) had significantly lower mean SBP compared to usual care group (P < 0.05).
Incomplete outcome data (attrition bias)	High risk	Unbalanced attrition: control (7/36 = 19.4%), intervention 1 (1/41 = 2.4%), intervention 2 (1/41 = 2.4%)
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Primary outcomes were objectively measured (HbA1c, BP, LDL, HTN‐c).
Selective reporting (reporting bias)	Low risk	Retrospectively registered (July 2016) following completion of enrolment (October 2015).
Risk of contamination (other bias)	High risk	One usual care site with 5 participants was not included in the final analysis over concern about violation of the cluster‐randomisation. This usual care site was activated in September and was joined by the lead study co‐ordinator from a 4‐week DMO site previously activated in May; this study co‐ordinator had intervened with both DMO and usual care participants.
Other bias	Low risk	No evidence of other bias.