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

Hermanides, J; Nørgaard, K; Bruttomesso, D; Mathieu, C; Frid, Anders LU ; Dayan, C M; Diem, P; Fermon, C; Wentholt, I M E and Hoekstra, J B L, et al. (2011) In Diabetic medicine : a journal of the British Diabetic Association 28. p.1158-1167
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... (More)
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. (Less)
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published
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Diabetic medicine : a journal of the British Diabetic Association
volume
28
pages
1158 - 1167
publisher
Wiley-Blackwell
external identifiers
  • WOS:000295003600006
  • PMID:21294770
  • Scopus:79960098673
ISSN
1464-5491
DOI
10.1111/j.1464-5491.2011.03256.x
language
English
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yes
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fa9f53b2-8ae0-4dd9-8b24-de9693eacc6c (old id 1832258)
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http://www.ncbi.nlm.nih.gov/pubmed/21294770?dopt=Abstract
date added to LUP
2011-03-01 12:56:43
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2017-02-12 04:23:37
@article{fa9f53b2-8ae0-4dd9-8b24-de9693eacc6c,
  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 &lt; 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.},
  author       = {Hermanides, J and Nørgaard, K and Bruttomesso, D and Mathieu, C and Frid, Anders and Dayan, C M and Diem, P and Fermon, C and Wentholt, I M E and Hoekstra, J B L and Devries, J H},
  issn         = {1464-5491},
  language     = {eng},
  pages        = {1158--1167},
  publisher    = {Wiley-Blackwell},
  series       = {Diabetic medicine : a journal of the British Diabetic Association},
  title        = {Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.},
  url          = {http://dx.doi.org/10.1111/j.1464-5491.2011.03256.x},
  volume       = {28},
  year         = {2011},
}