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Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.

In English

Författare

  • J Hermanides
  • K Nørgaard
  • D Bruttomesso
  • C Mathieu
  • Anders Frid
  • C M Dayan
  • P Diem
  • C Fermon
  • I M E Wentholt
  • J B L Hoekstra
  • J H Devries
Visa allt

Summary, in English

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.

Publiceringsår

2011

Språk

Engelska

Sidor

1158-1167

Publikation/Tidskrift/Serie

Diabetic Medicine: A journal of the British Diabetic Association

Volym

28

Dokumenttyp

Artikel i tidskrift

Förlag

Wiley-Blackwell

Ämne

  • Endocrinology and Diabetes

Status

Published

ISBN/ISSN/Övrigt

  • ISSN: 1464-5491