Individualizing treatment targets for elderly patients with type 2 diabetes: factors influencing clinical decision making in the 24-week, randomized INTERVAL study.
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We tested the feasibility of setting individualized glycemic goals and factors influencing targets set in a clinical trial in elderly patients with type 2 diabetes. A 24-week, randomized, double-blind, placebo-controlled study was conducted in 45 outpatient centers in seven European countries. 278 drug-naïve or inadequately controlled (mean HbA1c 7.9%) patients with type 2 diabetes aged ≥70 years with HbA1c levels ≥7.0% and ≤10.0% were enrolled. Investigator-defined individualized HbA1c targets and the impact of baseline characteristics on individualized treatment targets was evaluated. The average individualized HbA1c target was set at 7.0%. HbA1c at baseline predicted a target setting such that higher the HbA1c, more aggressive was the target (P<0.001). Men were more likely to be set aggressive targets than women (P=0.026). Frailty status of patients showed a trend towards significance (P=0.068), whereas diabetes duration, age, or polypharmacy did not. There was heterogeneity between countries regarding how baseline factors were viewed. Despite training and guidance to individualize HbA1c goals, targets were still set in line with conventional values. A strong influence of country-specific guidelines on target setting was observed; confirming the importance of further education to implement new international guidelines in older adults.
We gratefully acknowledge the INTERVAL study investigators and their staff at 45 participating centers. We also thank Anna Marie Hamann (DATAMAP, GmBH) and Rangan Gupta (Novartis Healthcare Private Limited) for technical and editorial support. WDS would like to acknowledge the support of the National Institute for Health Research (NIHR), Exeter Clinical Research Facility and the NIHR Biomedical Research Centre scheme. WDS is in receipt of a Higher Education Funding Council for the England “New-Blood” Clinical Senior Lectureship award. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. WDS was a member of Peninsula College of Medicine and Dentistry before the demerging of Peninsula into University of Exeter Medical School and Plymouth University Peninsula Schools of Medicine and Dentistry in 2012.
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Published: March 5, 2017