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

Rossi 2010.

Study characteristics
Methods Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open‐label, international, multicenter, randomized study
RCT (NA clusters and NA providers), conducted in 1) The study involved seven Diabetes Outpatient Clinics: 3 in Italy, 2 in England and 2 in Spain. 2) The course was provided as an outpatient programme of 3 encounters with the physician and/or dietitian in Italy
2 arms: 1. Control (standard carbohydrate counting educational programme) (control arm) and 2. Intervention (DID system) (intervention arm)
Participants Control arm N: 63
Intervention arm N: 67, NA, NA
Diabetes type: 1
Mean age: 35.74 ± NR
% Male: 42.96
Longest follow‐up: 6 months
Interventions Control arm: (standard carbohydrate counting educational programme)
Intervention arm: (DID system)
1) Case management
2) Facilitated relay of clinical information
3) Promotion of self‐management
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
Harms
Funding source Funding for this study was provided by Me.Te.Da. and Lifescan, Milpitas, CA
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation was performed through a telephone call to the co‐ordinating centre. Random lists were stratified by centre. To ensure equal allocation rates within centres, permuted block randomisation was used.
Allocation concealment (selection bias) Unclear risk Randomisation was performed through a telephone call to the co‐ordinating centre. Random lists were stratified by centre. To ensure equal allocation rates within centres, permuted block randomisation was used.
Patient's baseline characteristics (selection bias) Low risk Table 1 ‐ P values greater than 0.05.
Patient's baseline outcomes (selection bias) Low risk Table 1 ‐ P values greater than 0.05 except for triglycerides at 0.03.
Incomplete outcome data (attrition bias) High risk Loss of 2 in control, loss of 9 in intervention group; 3% vs 13%, respectively. Reasons provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Objective measures for HbA1c, cholesterol, BP, harms, subjective measure for hypo/hyperglycaemia
Selective reporting (reporting bias) Unclear risk No protocol registered. Outcomes match methods.
Risk of contamination (other bias) Low risk There does not appear to be any overlap between groups
Other bias Low risk None identified.