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Wiley, Diabetic Medicine, 10(28), p. 1158-1167

DOI: 10.1111/j.1464-5491.2011.03256.x

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Sensor-augmented pump therapy lowers HbA1c in suboptimally controlled Type-1 diabetes; a randomized controlled trial

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This paper is available in a repository.

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Abstract

Aims To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes. Methods In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18–65 years and HbA1c≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm® REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA1c between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed. Results The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA1c at baseline and at 26 weeks changed from 8.46% (sd 0.95) (69 mmol/mol) to 7.23% (sd 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (sd 0.82) (70 mmol/mol) to 8.46% (sd 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA1c after 26 weeks was −1.21% (95% confidence interval −1.52 to −0.90, P