Performance of an Electronic Diary System for Intensive Insulin Management in Global Diabetes Clinical Trials.

Autor:	Bastyr EJ 3rd; 1 Eli Lilly and Company , Indianapolis, Indiana.; 2 Indiana University School of Medicine , Indianapolis, Indiana., Zhang S; 1 Eli Lilly and Company , Indianapolis, Indiana., Mou J; 1 Eli Lilly and Company , Indianapolis, Indiana., Hackett AP; 3 PHT Corporation , Boston, Massachusetts., Raymond SA; 3 PHT Corporation , Boston, Massachusetts., Chang AM; 1 Eli Lilly and Company , Indianapolis, Indiana.
Jazyk:	angličtina
Zdroj:	Diabetes technology & therapeutics [Diabetes Technol Ther] 2015 Aug; Vol. 17 (8), pp. 571-9. Date of Electronic Publication: 2015 Mar 31.
DOI:	10.1089/dia.2014.0407
Abstrakt:	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. Materials and 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.
Databáze:	MEDLINE
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