Sensor‐augmented pump therapy lowers HbA 1c in suboptimally controlled Type 1 diabetes; a randomized controlled trial

Diabet. Med. 28, 1158–1167 (2011) 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 HbA 1c ≥ 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 HbA 1c 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 HbA 1c 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 HbA 1c after 26 weeks was −1.21% (95% confidence interval −1.52 to −0.90, P  < 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, P  = 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 ( P  = 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 HbA 1c in patients with Type 1 diabetes suboptimally controlled with multiple daily injections.