Dario 2017.

Study characteristics
Methods	Telemonitoring of type 2 diabetes mellitus in Italy RCT (NA clusters and NA providers), conducted in 1) This RCT was carried out within the Local Health Authority (LHA) of Alto Vicentino, in the Veneto Region, northern Italy, without major changes to the existing organisation. Participants were enrolled during planned specialist visits. The patients randomised to the TM group received home telehealth service. 2) Regional eHealth Center (ReHC) operators and clinicians delivered the intervention. In Italy 2 arms: 1. Control (UC: usual care) (control arm) and 2. Intervention (TM: telemonitoring) (intervention arm)
Participants	Control arm N: 91 Intervention arm N: 208, NA, NA Diabetes type: 2 Mean age: 73.05 ± NR % Male: 55.78 Longest follow‐up: 12 months
Interventions	Control arm: (UC: usual care) Intervention arm: (TM: telemonitoring) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Promotion of self‐management
Outcomes	Glycated haemoglobin
Funding source	The study is co‐founded by the European Commission and 21 partners from 9 European regions in the context of the REgioNs of Europe WorkINg toGether for HEALTH (RENEWING HEALTH) project
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was carried out following the randomisation table generated by PASS 2008 in a proportion of 2:1.
Allocation concealment (selection bias)	Low risk	A centralised online system associated the assigned ID to either the intervention or the control group.
Patient's baseline characteristics (selection bias)	Low risk	Tables 1 and 2. All P values above 0.05 except Mental Component Summary (MCS, P = 0.03).
Patient's baseline outcomes (selection bias)	Low risk	Table 1. All P values above 0.05.
Incomplete outcome data (attrition bias)	High risk	A total of 299 DM patients were randomised, 208 patients in the TM group and 91 patients in the control group. For HbA1c, they have data for 168 (19% lost) and 78 (14%) patients in the TM group and control group at 12 months follow‐up, respectively. High and quite unbalanced numbers. Reasons not balanced.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Our outcome of interest was objectively assessed (HbA1c).
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol. HbA1c listed as primary outcome in the protocol, but reported as secondary outcome in the paper. Quote paper: "The primary outcome was HRQoL... The secondary outcomes, measured at the start and at the conclusion of the follow‐up period, included HbA1c."
Risk of contamination (other bias)	Low risk	Patient‐RCT but unlikely that control patients used the telemonitoring system and had clinicians checked their data through a Home Care portal and took appropriate action.
Other bias	Low risk	No evidence of other bias.