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Insulin Delivery and Glucose Monitoring Methods for Diabetes Mellitus: Comparative Effectiveness

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Randomized controlled trials showed no difference in the effect on HbA1c between the CSII and MDI intervention groups for children and adolescents or pregnant women with type 1 diabetes or for adults with type 2 diabetes. However, results heavily influenced by a single study suggested that CSII had a significant HbA1c-lowering effect when compared with MDI. The trials showed no difference in rates of severe hypoglycemia between the two intervention groups for children, adolescents, and adults with type 1 diabetes or for adults with type 2 diabetes.

Limited evidence suggested that measures of quality of life or treatment satisfaction improved in patients with type 1 diabetes. The approach to intensive insulin therapy can, therefore, be individualized to patient preference to maximize quality of life.

This systematic review and meta-analysis of the comparative effectiveness of CSII and MDI on outcomes complements and extends previously published meta-analyses by: (1) including more studies of individuals with type 2 diabetes and of pregnant women with pre-existing type 1 diabetes; (2) only including studies in which rapidly acting insulin analogs were used and not regular insulin in the CSII intervention groups; and (3) requiring the MDI groups to receive at least three injections per day, the current standard for intensive insulin therapy. The latter two distinctions are important because these characteristics of intensive insulin therapy best reflect current clinical practice.

The authors of the systematic review only found studies of the comparative effectiveness of rt-CGM versus SMBG in children, adolescents, and adults with type 1 diabetes. When compared with the SMBG group, the rt-CGM group achieved a lower HbA1c (-0.3%). A sensitivity analysis showed this effect to be greater in studies where sensor compliance was 60 percent or greater (-0.36%). It is noteworthy that although statistically significant, this difference in HbA1c is below the 0.5-percent HbA1c difference that experts consider clinically meaningful.

Sensor-augmented pump use resulted in a statistically and clinically significant greater reduction in HbA1c when compared with MDI/SMBG use in nonpregnant individuals with type 1 diabetes (-0.61%). However, other combinations of these insulin delivery and glucose monitoring modalities were not evaluated.

Abbreviations: CSII = continuous subcutaneous insulin infusion; HbA1c = hemoglobin A1c; MDI = multiple daily injections; rt-CGM = real-time continuous glucose monitoring; SMBG = self-monitoring of blood glucose