Hypoglycemia in patient with type 2 diabetes treated with insulin: it can happen.

There are many misconceptions about the prevalence and effects of hypoglycemia in people with type 2 diabetes (T2D), including hypoglycemia does not occur or does not have adverse consequences in T2D. This narrative review aims to help dispel these myths. Around 25% of people with T2D taking insulin for >5 years were found to have severe hypoglycemic events, which is comparable to the severe hypoglycemia rate in adults with type 1 diabetes (T1D) diagnosed within 5 years. The total number of hypoglycemic events among insulin-treated T2D, including severe hypoglycemia, is as high or higher than among those with T1D. Recent evidence suggests serious consequences of hypoglycemia may, in some respects, be greater in individuals with T2D, particularly regarding effects on the cardiovascular system. Hypoglycemia is generally patient-reported. Issues with hypoglycemia unawareness, limited glucose testing, limited recall, lack of event logging and fear of failure or shaming limits the number of hypoglycemic episodes reported by people with diabetes. Barriers to healthcare provider inquiry and reporting include lack of knowledge regarding the problem's magnitude, competing priorities during patient visits, lack of incentives to report and limitations to documentation systems for adequate reporting. All people with diabetes should be encouraged to discuss their experiences with hypoglycemia without judgment or shame. Glucose targets, testing schedules (blood glucose or continuous glucose monitoring) and treatment plans should be reviewed often and individualized to the minimize risk of hypoglycemia. Finally, people with T2D on insulin should always be encouraged to have oral glucose and rescue medication immediately available.

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

Purpose The 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. Conclusions Clinically 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.

Impact of Out-of-Pocket Pharmacy Costs on Branded Medication Adherence Among Patients with Type 2 Diabetes.

BACKGROUND: Medication adherence is pivotal for the successful treatment of diabetes. However, medication adherence remains a major concern, as nonadherence is associated with poor health outcomes. Studies have indicated that increasing patients' share of medication costs significantly reduces adherence. Little is known about a potential out-of-pocket (OOP) cost threshold where substantial reduction in adherence may occur. OBJECTIVE: To examine the impact of diabetes OOP pharmacy costs on antihyperglycemic medication adherence and identify the potential threshold at which significant reduction in adherence may occur among patients with type 2 diabetes mellitus (T2DM). METHODS: This was an observational, retrospective cohort study using longitudinal U.S. pharmacy and medical claims data from the IMS Health Medical Claims (Dx) database. Patients with T2DM who initiated therapy with a branded antihyperglycemic medication during the index period (January 1, 2011, to December 31, 2011) and had 3 years of follow-up data were included. The primary outcome was adherence to antihyperglycemic medications, measured as the number of days covered. Propensity scores were calculated using baseline sociodemographic and clinical characteristics to control for potential confounding factors. Four strata were created based on mean propensity scores. Across each stratum, patients were assigned to 5 diabetes OOP pharmacy (including generics) cost levels: $0-$10, $11-$40, $41-$50, $51-$75, and > $75. Multivariate regression models were used to estimate association of diabetes OOP pharmacy costs and adherence for each stratum. Sensitivity analyses were conducted to assess the impact of total OOP pharmacy costs and index drug category OOP costs on adherence. RESULTS: A total of 15,416 patients were assessed. Across each stratum in the diabetes OOP pharmacy cost analysis group, mean patient age ranged from 52.3 to 56.1 years, mean number of antihyperglycemic medication classes ranged from 1.5 to 3.2, and mean household income ranged from $60,763 to $79,373. Most patients used a commercial plan (55%-85%). The propensity-stratified multivariate regression model revealed an overall negative relationship between diabetes OOP pharmacy costs and adherence across several OOP cost levels. Diabetes OOP pharmacy cost level $51-$75 appeared as the threshold at which adherence reduced significantly (77-78 fewer days of coverage over 3 years of follow-up; P < 0.05) when compared with the lowest OOP costs ($0-$10) across all strata. Adherence reduced further (99-145 fewer days of coverage; P < 0.0001) for the higher diabetes OOP pharmacy cost levels (> $75) when compared with the lowest OOP cost levels. Sensitivity analyses with total OOP pharmacy costs and index drug category OOP costs revealed negative association with adherence across all strata. CONCLUSIONS: Diabetes OOP pharmacy cost was negatively associated with patient adherence, and a potential OOP cost threshold ($51-$75) was identified at which adherence reduced significantly. The study findings may be beneficial in informing the design of health care plans to achieve optimal adherence and improve disease management in patients with T2DM. DISCLOSURES: This study was funded by Eli Lilly and Company. Eli Lilly and Company was involved in the study design; collection, analysis, and interpretation of data; preparation of the manuscript; and decision to submit for publication. Fu is an employee of Eli Lilly and Company. Taylor and Kwan are employees of Lilly USA. Fu and Kwan hold stock or stock options in Eli Lilly and Company. Bibeau was an employee of Eli Lilly and Company at the time of this study and initial submission of this manuscript. Bibeau is currently employed by Janssen Scientific Affairs. The abstract for this study was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2016; April 19-22, 2016; San Francisco, California. Bibeau and Fu contributed to the study design and collected the data. All authors contributed equally to data interpretation and manuscript preparation and revision.