Huizinga 2010.
| Study characteristics | ||
| Methods |
Preventing glycaemic relapse in recently controlled type 2 diabetes patients: a randomised controlled trial Patient RCT, conducted with patients recruited from urban area surrounding academic medical centre in Nashville, Tennessee ‐ recruited from those who completed an induction programme for poor glycaemic control, USA Three arms: 1. Control (control arm), 2. Quarterly follow‐up (intervention arm 1) and 3. Monthly follow‐up (intervention arm 2) |
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| Participants | Control arm N: 54 Intervention arm 1 N: 55 Intervention arm 2 N: 55 Diabetes type: type 2 Mean age: 55.1 ± 10.7 % Male: 56.0 Longest follow‐up: 24 months |
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| Interventions |
Control arm: None Intervention arm 1: 1) Case management 2) Team changes 3) Promotion of self‐management Intervention arm 2: 1) Case management 2) Team changes 3) Promotion of self‐management |
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| Outcomes | 1a) Harms (hypoglycaemia), N (%) Control arm: pre 36 (67), post 28 (58) Intervention arm 1: pre 30 (55), post 32 (70) Intervention arm 2: pre 31 (56), post 30 (58) 1b) Harms (severe hypoglycaemia), N (%) Control arm: pre 4 (7), post 3 (6) Intervention arm 1: pre 3 (5), post 3 (7) Intervention arm 2: pre 2 (4), post 5 (10) |
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| Funding source | The research was supported by the National Institute of Diabetes and Digestive and Kidney Disease R18 DK 062258, P60 DK 020593 and K24 DK 077875. M. M. Huizinga was supported by National Institute of Environmental Health Sciences 1 K12 ES 015855 and National Center for Research Resources 5 K12 RR 023266. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...using a computerised randomisation process." |
| Allocation concealment (selection bias) | Low risk | Quote: "...and assignments, which were concealed, were obtained sequentially from a computer program." |
| 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) | High risk | ~12% lost to follow‐up in N1 and N2. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | HbA1c: laboratory measurement described. Quote: "Blinding to assignment was not possible given the nature of the study." |
| Selective reporting (reporting bias) | Low risk | Checked protocol and everything proposed was completed. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | None identified. |