Table 6:
Author, Year | Measure of Hypoglycemia | Results | Difference | P-value | |
---|---|---|---|---|---|
Intervention | Control | ||||
Adult Population, RCTs | |||||
Bergenstal et al, 201025 | AUC of rate of patients having blood glucose < 50 mg/dL per day | 0.02 (SE 0.03)a | 0.03 (SE 0.07)a | −0.01 (SE 0.003)a | .16b |
Hermanides et al, 201127 | Mean number of hypoglycemic episodes (< 4.0 mmol/L) per day | 0.7 (SE 0.11)a | 0.6 (SE 0.12)a | 0.1 (95% CI −0.2 to 0.5)a | .40 |
Langeland et al, 201230 | Mean number of hypoglycemic episodes (≤ 3.1 mmol/L) per 4 weeks | 8.2 (SE 0.41)a | 7.3 (SE 0.36)a | 0.9 (95% CI 0.85–0.95)a | .67c |
Tumminia et al, 201538 | AUC of rate of patients having blood glucose < 70 mg/dL per day | Owing to concerns with the statistical analyses, results are not reportedd | NS | ||
Adult Population, Observational Studies | |||||
Radermecker et al, 201042 | Mean decrease from baseline in number of hypoglycemic episodes (< 60 mg/dL) per 14 days | 6.2 (95% CI 2.2–10.2) | 0.67 (95% CI −4.7 to 6.0) | Mean difference 5.3 (95% CI −0.49 to 11.55)a | .85a |
Soupal et al, 201643 | Mean reduction of % time spent in hypoglycemia | 6 (SE 0.87)a | 7 (SE 1.18)a,e | −1 (SE 2.39)d | .68 |
Pediatric Population, RCTs | |||||
Bergenstal et al, 201025 | AUC of rate of patients having blood glucose < 50 mg/dL | Owing to concerns with the statistical analyses, results are not reportedd | .64 | ||
Bukara-Radujkovic et al, 201126 | Difference in average number of hypoglycemic episodes (< 3.5 mmol/L) per day | 0.223 | 0.175 | 0.048 | NR |
Slover et al, 201137 | AUC of rate of patients having blood glucose < 60 mg/dL per day (change from baseline)e | Age 7–12: 0.05 (SD 0.08) Age 13–18: −0.05 (SD 0.08) | Age 7–12: 0.03 (SD 0.06) Age 13–18: −0.05 (SD 0.09) | Age 7–12: 0.02 (SD 0.16) Age 13–18: 0 (SD 0.15) | Age 7–12: .05 Age 13–18: .87 |
Abbreviations: AUC, area under the curve; CI, confidence interval; NR, not reported; NS, not significant; RCT, randomized controlled trial; SD, standard deviation; SE, standard error.
Calculations for SE and CI were conducted by the authors of this health technology assessment.
The reported P-value was adjusted for baseline differences, but the SE is for the unadjusted difference.
We could not replicate results for this P-value based on the methods and data reported by the authors.
Data were skewed, but the authors used statistical methods that are valid only under a symmetric assumption. Statistical results were questionable.
The study included both patients on insulin pumps and those on multiple daily injections, but these results were for only patients on multiple daily injections.