Table 1: GRADE Quality Assessment for CSII pumps vs. MDI on HbA1c, Mean Blood Glucose, and Glucose Variability For Adults with Type 1 Diabetes.
| Outcome | Study | Design | Study Quality |
Consistency | Directness | Other modifying factors |
Overall quality of evidence |
|---|---|---|---|---|---|---|---|
| HbA1c |
Hanaire-Broutin 2000 |
RCT |
Serious limitations* |
Consistency† |
Indirect‡ |
||
| Mean Blood Glucose | Brutomesso 2008 | RCT | Not applicable | ||||
| Glucose Variability | DeVries 2002 | RCT | LOW | ||||
| Hoogma 2005 | RCT HIGH |
MODERATE | MODERATE | LOW |
Inadequate or unknown allocation concealment (3/4 studies); Unblinded assessment (all studies) however lack of blinding due to the nature of the study; No ITT analysis (2/4 studies); possible bias SMBG (all studies)
HbA1c: 3/4 studies show consistency however magnitude of effect varies greatly; Single study uses insulin glargine instead of NPH; Mean Blood Glucose: 3/4 studies show consistency however magnitude of effect varies between studies; Glucose Variability: All studies show consistency but 1 study only showed a significant effect in the morning
Generalizability in question due to varying populations: highly motivated populations, educational component of interventions/ run-in phases, insulin pen use in 2/4 studies and varying levels of baseline glycemic control and experience with intensified insulin therapy, pumps and MDI.