Abstract
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.
Highlights
Type 2 diabetes is one of the most common chronic diseases in older populations, affecting ~ 20.0% of individuals with age >75 years [1, 2]
Global guidelines for the management of type 2 diabetes advocate individualization of target setting, to date, the INTERVAL study is the first and only clinical study to explore the feasibility of setting such targets, let alone the evaluation of achieving these in a clinical setting
This study is the first to explore the independent determinants of the targets that were set and, thereby, determine the specific areas of education that may be required to facilitate more appropriate target setting for elderly adults with type 2 diabetes
Summary
Type 2 diabetes is one of the most common chronic diseases in older populations, affecting ~ 20.0% of individuals with age >75 years [1, 2]. A considerable proportion of these older individuals have multiple comorbidities due in part to their longevity [3, 4]. Older individuals with diabetes have significantly increased risk of microvascular and macrovascular disease, cognitive dysfunction, functional impairment, depression, and vision and hearing impairment compared with younger adults [5, 6]. The recent global guidelines for the treatment of elderly patients have emphasized on the need of a holistic and individualized approach to patient management and setting appropriate targets for this population [2, 6,7,8,9,10]. There is no evidence to date that setting these individualized targets is even feasible, let alone assessing whether they can be achieved or improve outcomes [5, 6, 9, 10]
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