Translating U-500R Randomized Clinical Trial Evidence to the Practice Setting: A Diabetes Educator/Expert Prescriber Team Approach

Abstract

PurposeThe purpose of this article is to provide recommendations to the diabetes educator/expert prescriber team for the use of human regular U-500 insulin (U-500R) in patients with severely insulin-resistant type 2 diabetes, including its initiation and titration, by utilizing dosing charts and teaching materials translated from a recent U-500R clinical trial.ConclusionsClinically relevant recommendations and teaching materials for the optimal use and management of U-500R in clinical practice are provided based on the efficacy and safety results of and lessons learned from the U-500R clinical trial by Hood et al, current standards of practice, and the authors’ clinical expertise. This trial was the first robustly powered, randomized, titration-to-target trial to compare twice-daily and three-times-daily U-500R dosing regimens. Modifications were made to the initiation and titration dosing algorithms used in this trial to simplify dosing strategies for the clinical setting and align with current glycemic targets recommended by the American Diabetes Association. Leveraging the expertise, resources, and patient interactions of the diabetes educator who can provide diabetes self-management education and support in collaboration with the multidisciplinary diabetes team is strongly recommended to ensure patients treated with U-500R receive the timely and comprehensive care required to safely and effectively use this highly concentrated insulin.

Intensive, telemedicine-based, self-management program for rural, underserved patients with diabetes mellitus: Re-entry of retired endocrinologists into practice

“…U-500 was chosen for patients with severe insulin resistance and uncontrolled glucose levels when treated with more than 200 units daily. 37,38 Of the total of 139 patients, 113 or 81% had an A1C levels of ≥9.0% at the beginning of the program. Nearly all referred patients had been started on various agents before referral and these were generally continued with additional therapeutic modalities added according to the AACE's algorithm.…”

High concentration insulin

“…At the same time, due diligence must be practiced while selecting patients for U500 regular therapy. [ 19 22 ] Red flags (i.e., potential or relative contraindications) include poor adherence, hypoglycemia unawareness, high risk of age, cognitive/psychiatric impairment, and inability to take regular meals. U500 regular insulin should not be administered with other insulin preparations as it covers both prandial and basal needs.…”