. 2018 Feb 21;18(2):1–160.

Table 6:

Results for Hypoglycemia

Author, Year	Measure of Hypoglycemia	Results		Difference	P-value
Author, Year	Measure of Hypoglycemia	Intervention	Control	Difference	P-value
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	.16^b
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	.67^c
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 reported^d			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	.85^a
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 reported^d			.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.