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

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)
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
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
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)
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.