Clinical Studies

COMISAIR STUDY

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COMISAIR study: Comparing treatment modalities, including insulin pump with CGM, over 52 weeks

A 2016 study of type 1 patients on insulin compared real-time continuous glucose monitoring (RT-CGM) with self-monitored blood glucose (SMBG), along with insulin pump usage and multiple daily insulin injections (MDIs). 65 patients were followed for a year.

Of these, 27 started RT-CGM as part of a glucose sensor augmented insulin regimen (SAIR). Within this SAIR group, 15 subjects started sensor-augmented pump (SAP) therapy and the remaining 12 continued with MDIs (MDIs + RT-CGM). A second group of 20 patients initiated continuous subcutaneous insulin infusion (CSII) without RT-CGM, while a third group of 18 subjects continued on MDIs and SMBG.

Study enpoints included A1C reduction, glycemic variability and incidence of hypoglycemia. The SAIR groups, which used CGM in conjunction with insulin pump therapy, saw baseline mean A1C reduced from 8.3% to 7.1%. Other groups using CGM saw comparable improvement. The study concluded that CGM use can improve A1C, independent of insulin delivery method.

Study highlights:

Average .75% reduction in A1C in CGM augmented regimens compared to group using insulin pump therapy and self-monitoring of blood glucose

25% reduction of average time spent in hypoglycemia in CGM-augmented group compared to baseline

38% increase of average time spent in range (72 mg/dL-180 mg/dL) in CGM-augmented group compared to baseline

Source: Šoupal J, Petruželková L, Flekač M, et al. Comparison of Different Treatment Modalities for Type 1 Diabetes, Including Sensor-Augmented Insulin Regimens, in 52 Weeks of Follow-Up: A COMISAIR Study. Diabetes Technology & Therapeutics. 2016;18(9):532-538. doi:10.1089/dia.2016.0171.

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