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) |
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| 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 |
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| 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 |
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| Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Harms |
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| 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. |