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Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12‐month data from the OpT2mise randomized trial
Author(s) -
Aronson R.,
Reznik Y.,
Conget I.,
Castañeda J. A.,
Runzis S.,
Lee S. W.,
Cohen O.
Publication year - 2016
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12642
Subject(s) - medicine , insulin pump , randomization , randomized controlled trial , type 2 diabetes , insulin , type 1 diabetes , clinical endpoint , diabetes mellitus , surgery , anesthesia , endocrinology
Aims To compare insulin pump therapy and multiple daily injections ( MDI ) in patients with type 2 diabetes receiving basal and prandial insulin analogues. Methods After a 2‐month dose‐optimization period, 331 patients with glycated haemoglobin ( HbA1c ) levels ≥8.0% and ≤12% were randomized to pump therapy or continued MDI for 6 months [randomization phase ( RP )]. The MDI group was subsequently switched to pump therapy during a 6‐month continuation phase ( CP ). The primary endpoint was the between‐group difference in change in mean HbA1c from baseline to the end of the RP . Results The mean HbA1c at baseline was 9% in both groups. At the end of the RP , the reduction in HbA1c was significantly greater with pump therapy than with MDI (−1.1 ± 1.2% vs −0.4 ± 1.1%; p < 0.001). The pump therapy group maintained this improvement to 12 months while the MDI group, which was switched to pump therapy, showed a 0.8% reduction: the final HbA1c level was identical in both arms. In the RP , total daily insulin dose ( TDD ) was 20.4% lower with pump therapy than with MDI and remained stable in the CP . The MDI –pump group showed a 19% decline in TDD , such that by 12 months TDD was equivalent in both groups. There were no differences in weight gain or ketoacidosis between groups. In the CP , one patient in each group experienced severe hypoglycaemia. Conclusions Pump therapy has a sustained durable effect on glycaemic control in uncontrolled type 2 diabetes.