Sequeira 2013.
Study characteristics | ||
Methods |
Continuous glucose monitoring pilot in low‐income type 1 diabetes patients Patient RCT, conducted in an endocrine Fellows Diabetes Clinic at the Roybal Comprehensive Health Center in East Los Angeles, USA Two arms: 1. SMBG (control arm) and 2. CGM (intervention arm) |
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Participants | Control arm N: 20 Intervention arm N: 19 Diabetes type: type 1 Mean age: 40.0 ± 13.0 % Male: 52.0 Longest follow‐up: 7 months |
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Interventions |
Control arm: 1) Facilitated relay of clinical information 2) Promotion of self‐management Intervention arm: 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.3 (NR), post 7.8 (NR) Intervention arm: pre 8.3 (NR), post 8.0 (NR) |
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Funding source | This project was funded by JDRF Artificial Pancreas grant 22‐2006‐1119 | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Unclear risk | Not reported. |
Patient's baseline outcomes (selection bias) | Unclear risk | Not reported: HbA1c. |
Incomplete outcome data (attrition bias) | High risk | ~10% lost to follow‐up in N1; ~21% in N2, provide numbers of lost to follow‐up, however, more losses in N2 (double), reasons after 1 week not really provided for all dropouts. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: HbA1c, used a DCA Vantage 2000 Analyzer. |
Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match results. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | Information not available. |