title: Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Academic Medical Centre, Amsterdam, The Netherlands. j.hermanides@amc.uva.nl
authors.forename: J
authors.initials: J
authors.lastname: Hermanides
authors.forename: K
authors.initials: K
authors.lastname: Nørgaard
authors.forename: D
authors.initials: D
authors.lastname: Bruttomesso
authors.forename: C
authors.initials: C
authors.lastname: Mathieu
authors.forename: A
authors.initials: A
authors.lastname: Frid
authors.forename: C M
authors.initials: CM
authors.lastname: Dayan
authors.forename: P
authors.initials: P
authors.lastname: Diem
authors.forename: C
authors.initials: C
authors.lastname: Fermon
authors.forename: I M E
authors.initials: IM
authors.lastname: Wentholt
authors.forename: J B L
authors.initials: JB
authors.lastname: Hoekstra
authors.forename: J H
authors.initials: JH
authors.lastname: DeVries
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004867:Equipment Design; D005060:Europe / Q000453:epidemiology; D006442:Glycated Hemoglobin / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D015918:Infusion Pumps, Implantable; D007267:Injections; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin