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

TY - JOUR

T1 - Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial

AU - Hermanides, J

AU - Nørgaard, K

AU - Bruttomesso, D

AU - Mathieu, Christophe John

AU - Frid, A

AU - Dayan, C M

AU - Diem, P

AU - Fermon, C

AU - Wentholt, I M E

AU - Hoekstra, J B L

AU - DeVries, J H

N1 - © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

PY - 2011/10

Y1 - 2011/10

N2 - Aims To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type1 diabetes. Methods In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type1 diabetes (40 women) currently treated with multiple daily injections, age 18-65years and HbA 1c≥8.2% (≥66mmol/mol) to 26weeks 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 26weeks, 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 26weeks changed from 8.46% (sd0.95) (69mmol/mol) to 7.23% (sd0.65) (56mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (sd0.82) (70mmol/mol) to 8.46% (sd1.04) (69mmol/mol) in the multiple daily injections group. Mean difference in change in HbA 1c after 26weeks 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 Type1 diabetes suboptimally controlled with multiple daily injections.

AB - Aims To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type1 diabetes. Methods In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type1 diabetes (40 women) currently treated with multiple daily injections, age 18-65years and HbA 1c≥8.2% (≥66mmol/mol) to 26weeks 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 26weeks, 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 26weeks changed from 8.46% (sd0.95) (69mmol/mol) to 7.23% (sd0.65) (56mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (sd0.82) (70mmol/mol) to 8.46% (sd1.04) (69mmol/mol) in the multiple daily injections group. Mean difference in change in HbA 1c after 26weeks 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 Type1 diabetes suboptimally controlled with multiple daily injections.

U2 - 10.1111/j.1464-5491.2011.03256.x

DO - 10.1111/j.1464-5491.2011.03256.x

M3 - Journal article

C2 - 21294770

SN - 0742-3071

VL - 28

SP - 1158

EP - 1167

JO - Diabetic Medicine

JF - Diabetic Medicine

IS - 10

ER -