Nicolucci 2015.

Study characteristics
Methods	A randomized trial on home telemonitoring for the management of metabolic and cardiovascular risk in patients with type 2 diabetes RCT (NA clusters and NA providers), conducted in 1) Multicentre study conducted in the area of general practice (primary care setting). 2) Home telehealth (HT) intervention carried out by general practitioners and nurses in Italy 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (home telehealth) (intervention arm)
Participants	Control arm N: 149 Intervention arm N: 153, NA, NA Diabetes type: 2 Mean age: 58.46 ± NR % Male: 61.55 Longest follow‐up: 12 months
Interventions	Control arm: (usual care) Intervention arm: (home telehealth) 1) Case management 2) Electronic patient registry 3) Clinician reminder 4) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management 7) Patient reminders
Outcomes	Lipid‐lowering drugs Antihypertensive drug Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Hypertension control Harms
Funding source	This study was supported by a research grant to A.N. from MSD Italia (Merck & Co. Inc. ou Merck Sharp and Dohme)
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Group allocation was based on centralised telephone randomisation, stratified by participating physician and by treatment (oral agents, insulin). Permuted blocks randomisation was used.
Allocation concealment (selection bias)	Low risk	Group allocation was based on centralised telephone randomisation, stratified by participating physician and by treatment (oral agents, insulin). Permuted blocks randomisation was used.
Patient's baseline characteristics (selection bias)	High risk	Patients in the control group had higher dyslipidaemia percentage (49.7% vs 36.7%, P = 0.02).
Patient's baseline outcomes (selection bias)	Low risk	Patients in the control group had slightly higher diastolic blood pressure values (87.2 ± 4.6 vs 86.2 ± 4.0, P = 0.05). More likely to have dyslipidaemia in control group. See Table 1.
Incomplete outcome data (attrition bias)	High risk	Overall, 29 general practitioners from 2 health districts enrolled 302 patients, of whom 153 were assigned to the telemedicine group and 149 to the control group. Shortly after randomisation, 39 participants in the telemedicine group and 14 participants in the control group withdrew their consent (unbalanced numbers). Consequently, 82.5% of the total sample completed the 12‐month assessment (17.5% loss). Some of the patients withdrew their consent shortly after randomisation, mainly for the complexity of the study design or the difficulty in using the telemedicine tools. A few patients also abandoned the study because of emotional problems caused by using the system (reasons related to intervention).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Objective outcomes. Clinical information was collected at baseline, after 6 months, and after 12 months, using an ad hoc clinical record form. Blood samples were collected on the same occasions, and HbA1c levels and lipid profiles were measured in a centralised laboratory.
Selective reporting (reporting bias)	Unclear risk	According to the retrospectively registered protocol (protocol first posted in July 2014, recruitment started in October 2011, 1‐year intervention), the primary outcomes were blood glucose level, blood pressure and BMI. However, they do not report data for blood glucose levels at baseline and after the intervention. They also do not report BMI data after intervention, just the weight.
Risk of contamination (other bias)	Low risk	Unlikely control group received treatment as only those randomised to intervention received telemedicine monitoring system. Group allocation was stratified by participating physician.
Other bias	Low risk	None identified.