Search. Read. Cite.

Easy to search. Easy to read. Easy to cite with credible sources.

Diabetic Medicine

Year: 2011  |  Volume: 28  |  Issue: 10  |  Page No.: 1158 - 1167

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

J. Hermanides, K. Norgaard, D. Bruttomesso, C. Mathieu, A. Frid, C. M. Dayan, P. Diem, C. Fermon, I. M. E. Wentholt, J. B. L. Hoekstra and J. H. DeVries

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, < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (= 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group.

Conclusions  Sensor augmented pump therapy effectively lowers HbA1c in patients with Type 1 diabetes suboptimally controlled with multiple daily injections.

View Fulltext