Montori 2004.
Study characteristics | ||
Methods |
Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta‐analysis Patient RCT, Canada Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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Participants | Control arm N: 16 Intervention arm N: 15 Diabetes type: type 1 Mean age: 42.9 (interquartile range: 24.4 to 52.7) % Male: 32.3 Longest follow‐up: 6 months |
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Interventions |
Control arm: 1) Promotion of self‐management Intervention arm: 1) Case management 2) Facilitated relay of clinical information 3) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.8 (1.2), post 8.2 (1.2) Intervention arm: pre 9.1 (1.3), post 7.8 (1.3) 2a) Harms (severe hypoglycaemia), N (%) Control arm: pre NR (NR), post 3 (19) Intervention arm: pre NR (NR), post 3 (20) 2b) Harms (ketoacidosis), N (%) Control arm: pre NR (NR), post 0 (0) Intervention arm: pre NR (NR), post 0 (0) |
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Funding source | The Mayo Foundation funded this study with a research award to Y.C.K. Roche Diagnostics donated modems and glucometer equipment for both study groups | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Information not available. |
Allocation concealment (selection bias) | Low risk | Information not available. |
Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
Incomplete outcome data (attrition bias) | Low risk | Information not available. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Information not available. |
Selective reporting (reporting bias) | Low risk | Information not available. |
Risk of contamination (other bias) | High risk | Information not available. |
Other bias | Unclear risk | Information not available. |