title: Performance of an Electronic Diary System for Intensive Insulin Management in Global Diabetes Clinical Trials.
abstract: BACKGROUND
  This report describes the performance of a wireless electronic diary (e-diary) system for data collection and enhanced patient-investigator interactions during intensive insulin management in diabetes clinical trials.
  
  
  METHODS
  We implemented a customized electronic communication system featuring an e-diary and a Web portal in three global, randomized, controlled Phase 3 clinical trials testing basal insulin peglispro compared with insulin glargine, both combined with prandial insulin lispro, in patients with type 1 or type 2 diabetes mellitus (T1DM and T2DM, respectively). We collected data during 28 weeks of study e-diary use for the report.
  
  
  RESULTS
  Patients (n=2,938) in 31 countries used e-diaries to transmit 2,439,087 blood glucose (BG) values, 96% of which were associated by the patient with a protocol time point during the 72-h response window. Of 208,192 hypoglycemia events captured, 96% had a BG value, and 95% had treatments and outcomes entered by patients within the 72-h window. Patients recorded administration of 1,964,477 insulin doses; 93% of basal insulin doses were adherent with the investigator prescription. Investigators adjusted 13 basal and 92 bolus insulin prescriptions per patient-year using the e-diary system. After 26 weeks of treatment and e-diary use in the combined study arms, hemoglobin A1c values decreased by 0.6% or 1.6% and fasting BG decreased by 7.8 or 28 mg/dL in patients with T1DM or T2DM, respectively.
  
  
  CONCLUSIONS
  The e-diary system enabled comprehensive data collection and facilitated communication between investigators and patients for intensive insulin management in three global clinical trials testing basal insulins.
authors.affiliation: 1 Eli Lilly and Company , Indianapolis, Indiana.|2 Indiana University School of Medicine , Indianapolis, Indiana.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Bastyr
authors.affiliation: 1 Eli Lilly and Company , Indianapolis, Indiana.
authors.forename: Shuyu
authors.initials: S
authors.lastname: Zhang
authors.affiliation: 1 Eli Lilly and Company , Indianapolis, Indiana.
authors.forename: Jiani
authors.initials: J
authors.lastname: Mou
authors.affiliation: 3 PHT Corporation , Boston, Massachusetts.
authors.forename: Andy P
authors.initials: AP
authors.lastname: Hackett
authors.affiliation: 3 PHT Corporation , Boston, Massachusetts.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Raymond
authors.affiliation: 1 Eli Lilly and Company , Indianapolis, Indiana.
authors.forename: Annette M
authors.initials: AM
authors.lastname: Chang
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D055695:Electronic Prescribing / Q000706:statistics & numerical data; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D000069036:Insulin Glargine / Q000008:administration & dosage; D061268:Insulin Lispro / Q000008:administration & dosage; D049528:Insulin, Long-Acting / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000295:instrumentation*; D013686:Telemetry / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D061268:Insulin Lispro; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human
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