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

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)
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
Interventions Control arm:
1) Promotion of self‐management
Intervention arm:
1) Case management
2) Facilitated relay of clinical information
3) Promotion of self‐management
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)
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.