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Diabetes

A randomized study on the usefulness of an electronic outpatient hypoglycemia risk calculator for clinicians of patients with diabetes in a safety-net institution

, , , , , , , , , , , & show all
Pages 583-593 | Received 04 Dec 2018, Accepted 13 Jan 2020, Published online: 06 Feb 2020
 

Abstract

Objective

Hypoglycemia (HG) occurs in up to 60% of patients with diabetes mellitus (DM) each year. We assessed a HG alert tool in an electronic health record system, and determined its effect on clinical practice and outcomes.

Methods

The tool applied a statistical model, yielding patient-specific information about HG risk. We randomized outpatient primary-care providers (PCPs) to see or not see the alerts. Patients were assigned to study group according to the first PCP seen during four months. We assessed prescriptions, testing, and HG. Variables were compared by multinomial, logistic, or linear model. ClinicalTrials.gov ID: NCT04177147 (registered on 22 November 2019).

Results

Patients (N = 3350) visited 123 intervention PCPs; 3395 patients visited 220 control PCPs. Intervention PCPs were shown 18,645 alerts (mean of 152 per PCP). Patients’ mean age was 55 years, with 61% female, 49% black, and 49% Medicaid recipients. Mean baseline A1c and body mass index were similar between groups. During follow-up, the number of A1c and glucose tests, and number of new, refilled, changed, or discontinued insulin prescriptions, were highest for patients with highest risk. Per 100 patients on average, the intervention group had fewer sulfonylurea refills (6 vs. 8; p < .05) and outpatient encounters (470 vs. 502; p < .05), though the change in encounters was not significant. Frequency of HG events was unchanged.

Conclusions

Informing PCPs about risk of HG led to fewer sulfonylurea refills and visits. Longer-term studies are needed to assess potential for long-term benefits.

Transparency

Declaration of funding

Funding for this research was provided by Merck & Co., Inc., Kenilworth, NJ, USA. Authors affiliated with Merck assisted in designing the study, interpreting findings, and reviewing and editing the manuscript.

Declaration of financial/other relationships

AR, KI, SSE, SR, AKC, and LR are or were full-time employees of Merck & Co. Inc., Kenilworth, NJ, USA at the time of the analysis and may own stock or hold stock options in the company. LR subsequently moved to Peloton Advantage, Parsippany, NJ, USA. KI subsequently left Merck. KK moved to Onebridge, Indianapolis, Indiana, USA. MW, JC, SO, ET, XL, and JB received research support from Merck & Co. Inc., Kenilworth, NJ, USA for the conduct of this study. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

We thank Rachel Gruber for assistance in formatting and meeting publication requirements. Dr. Weiner is Chief of Health Services Research and Development at the Richard L. Roudebush Veterans Affairs Medical Center in Indianapolis, Indiana. The views expressed in this article are those of the authors and do not necessarily represent the views of Merck & Co., Inc. or the U.S. Department of Veterans Affairs.

Previous presentations

Parts of this work were presented at the Society of General Internal Medicine 38th Annual Meeting, Toronto, Canada, 22 April 2015.

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