Medi‐Cal Group 2004.
| Study characteristics | ||
| Methods |
Closing the gap: effect of diabetes case management on glycemic control among low‐income ethnic minority populations: the California Medi‐Cal type 2 diabetes study Patient RCT, conducted in clinical sites in Santa Barbara, San Diego, Los Angeles serving racial/ethnic minority, low‐income Medi‐Cal populations, USA Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 172 Intervention arm N: 186 Diabetes type: type 2 Mean age: 57.0 ± 0.9 % Male: 28.3 Longest follow‐up: 25.3 months (mean) |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SE) Control arm: pre 9.7 (0.1), post 8.5 (0.2) Intervention arm: pre 9.6 (0.1), post 7.7 (0.2) 2) SBP, mean mmHg (SE) Control arm: pre 134.0 (NR), post 134.6 (NR) Intervention arm: pre 136.0 (NR), post 133.4 (NR) 3) DBP, mean mmHg (SE) Control arm: pre 76.0 (1.0), post 75.5 (NR) Intervention arm: pre 81.0 (4.0), post 74.4 (NR) 4) LDL, mean mg/dL (SE) Control arm: pre 130.1 (3.6), post 121.0 (NR) Intervention arm: pre 129.8 (3.2), post 115.6 (NR) 5) Harms (severe hypoglycaemia), N (%) Control arm: pre NR (NR), post 6 (3) Intervention arm: pre NR (NR), post 13 (7) |
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| Funding source | The State of California Medi‐Cal Managed Care Division and Center for Disease Control and Prevention funded the study. The study also received support from the GCRC at Harbor‐UCLA Medical Center grant number MO1‐RR00425. | |
| 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 | Sealed envelopes but not opaque. |
| 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) | Unclear risk | Information not available. |
| Other bias | Low risk | Information not available. |