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

Trento 2008.

Study characteristics
Methods A randomised controlled clinical trial of nurse‐, dietitian‐ and pedagogist‐led group care for the management of Type 2 diabetes
Patient RCT, conducted in Italy
Two arms: 1. Controls (control arm) and 2. Group care (intervention arm)
Participants Control arm N: 24
Intervention arm N: 25
Diabetes type: type 2
Mean age: 66.3 ± 8.2
% Male: 59.2
Longest follow‐up: 24 months
Interventions Control arm:
1) Patient education
Intervention arm:
1) Team changes
2) Patient education
3) Promotion of self‐management
Outcomes 1) Antihypertensives (any), N users (%)
Control arm: pre 18 (75), post 17 (81)
Intervention arm: pre 10 (40), post 10 (42)
2) HbA1c, mean % (SD)
Control arm: pre 8.0 (1.1), post 8.4 (1.3)
Intervention arm: pre 8.0 (1.3), post 7.6 (0.8)
3) SBP, mean mmHg (SD)
Control arm: pre 144.8 (23.6), post 150.0 (30.0)
Intervention arm: pre 145.0 (22.7), post 135.0 (23.5)
4) DBP, mean mmHg (SD)
Control arm: pre 80.4 (10.7), post 76.0 (11.8)
Intervention arm: pre 81.0 (11.5), post 76.0 (9.8)
Funding source "This article was supported by funds from the University of Turin (fondi 60%)".
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Information not available.
Allocation concealment (selection bias) Unclear 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) High risk Information not available.
Selective reporting (reporting bias) Low risk Information not available.
Risk of contamination (other bias) Unclear risk Information not available.
Other bias Low risk Information not available.