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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Bertuzzi 2018.

Study characteristics
Methods Teleconsultation in type 1 diabetes mellitus (TELEDIABE)
RCT (NA clusters and NA providers), conducted in 1) 2 diabetes outpatient centres in Italy, 2) diabetologist, physicians, nutrition and psychological specialists in Italy
2 arms: 1) Control (standard care) (control arm) and 2) Intervention (Teleconsultation ‐ TELEDIABE) (intervention arm)
Participants Control arm N: 40
Intervention arm N: 37, NA, NA
Diabetes type: 1
Mean age: 34.96 ± 10.07
% Male: 38.5
Longest follow‐up: 12 months
Interventions Control arm: (standard care)
Intervention arm: (Teleconsultation ‐ TELEDIABE)
1) Case management
2) Team change
3) Electronic patient registry
4) Facilitated relay of clinical information
5) Patient education
6) Promotion of self‐management
Outcomes Glycated haemoglobin
Harms
Funding source The Italian Diabetes Foundation ‐ thanks to a financial support received from Intesa Sanpaolo Foundation ‐ covered the overall costs of the project
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed with the use of a computer‐generated random sequence.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. P values provided and greater than 0.05. 
Patient's baseline outcomes (selection bias) Low risk Table 1. P values provided and greater than 0.05.
Incomplete outcome data (attrition bias) Low risk The dropout rate for group A was 1 out of 40 patients (2.5%), and for group B was 2 out of 37 patients (5.4%).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Objective measure for HbA1c; not sure whether patient‐reported harms.
Selective reporting (reporting bias) Unclear risk Retrospectively registered protocol. Paper reported harms, protocol did not list it. Time frame in protocol for change in HbA1c is 3rd to 6th to 9th month, in report time frame is 4, 8 and 12 months. Reduction in acute complications is a secondary outcome in the publication but not in the protocol.
Risk of contamination (other bias) Low risk Patient‐randomised. Control patients did not have access to the teleconsultation intervention.
Other bias High risk The enrollment of patients was stopped at 77 patients: the financial support was stopped due to the prolongation of the activities over the planned timeline. For this reason, a futility analysis was performed. A non‐planned futility analysis was performed when the trial was terminated for lack of funding resources The enrollment of the patients was not concluded due to the economical budget restrictions. Due to some organisational problems, the time for patient enrollment lasted more than expected and they lost the economic support from a private foundation. The study was therefore closed ahead of time. This is the reason why the number of enrolled patients was lower than expected. Secondly, the primary outcome, the superiority of teleconsultation versus standard visit, was not reached. The main outcome was probably a bit ambitious. The possibility that the teleconsultation might be superior to standard visits was probably a difficult challenge: the quality of clinical assistance, the time for the visit and the physicians involved were the same.