FDA-Approved Diabetes Innovations; and At-Risk Patients Rejecting Statins

March brings 3 diabetes product innovations, a clinician office task organizer app, and a warning about patient perceptions regarding attatins: they don't need them.

With Timothy Bailey, MD, and Robert Rosenson, MD

Improved diabetes control will get easier as more new device innovations reach the market.

FDA Grants Approval to Medtronic for 3 Diabetes Products

Medtronic was granted approval from the Food and Drug Administration for three new devices:

  • Resolute Onyx 2.0 mm drug-eluting heart stent, the smallest on the market, is intended to treat the most narrow, previously difficult to reach blocked coronary blood vessels; the stent expands to 3.25 mm after insertion using a minimally invasive procedure.1
  • Guardian Sensor 3 continuous glucose monitor (CGM) to be used in tandem with the MiniMed 670G insulin pump for use on the upper arm, which is an added indication following approval for use on the abdomen to measure the amount of insulin in the blood; for anyone over age 14 years with type 1 diabetes.2 This is currently the only insulin pump available that is able to automatically adjust glucose delivery based on continuous glucose sensor readings.
  • Guardian Connect CGM system for people (ages 14 to 75 years) with diabetes is the first and only standalone CGM product that has the capability to alert patients of possible hypoglycemic drops up to 60 minutes in advance with 98.5% accuracy, according to clinical data.3 Designed to support patients who struggle with glucose highs and lows, the Guardian Sensor 3—the most advanced glucose sensor to date, able to power a hybrid closed-loop system—provides real-time tracking of glucose levels. Warnings are provided in real time as well as sent by text.3 In addition, Medtronic will provide patients using this system with sole use of Sugar.IQ, a smart diabetes assistant app (compatible with > IOS9 but not capable of use with MiniMed pump) using IBM Watson Health artificial health technology to receive continuous information on glucose levels following insulin dosing, food intake, and daily glucose trends.

Patients who struggle with their glucose control will now receive individualized feedback when using both the Guardian Connect CGM system and the Sugar.IQ app to improve their ability to remain in their target range.

"Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use CGM," said Timothy Bailey, MD, clinical associate professor at the University of California, San Diego. "Newer sensors paired with intelligent algorithms that help to both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensible for people who inject insulin. Greater utilization of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia," he said, in a company press release.

Medtronic's Guardian Connect is expected to reach the market in mid-2018.

Patients With Greatest Need for Statins Require Closer Attention

Patients at high risk for cardiovascular disease discontinue statins due to “lack of perceived need,” 4 according to Robert Rosenson, MD, director of cardiometabolic disorders during a presentation at the American College of Cardiology Scientific Sessions in Orlando, Florida, “and they refuse to resume therapy.” The reasons range from professed muscle pain, which is more likely attributable to arthritis, or arising as a response to something they read online or heard in the news.

Based on an analysis of 7,216 patients who participated in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) trial,5 15% of patients stopped taking a much needed lipid-lowering medication. Among the patients who discontinued their statin, 27.6% has a history of cardiovascular disease (CVD), 25.4% had diabetes, 34.8% were considered at high risk for CVD, and another 31.8% has a one year CVD risk of less than 7.5%.4

Despite their risk category, these patients decided that they did not need the medication, with more than half who had diabetes and 69.4% with diagnosed CVD refusing to reinstate their statin.4

The Takeway—It’s important to discuss the dosage and likelihood of adverse events with each patient at the outset, and to offer to adjust the dose for perceived side effects provided the patient is willing to call and discuss any concerns before discontinuing treatment on their own.

Best new app: Managerial Organizing Tool for Clinician

When the administrative side of patient care gets in the way of seeing patients, having an app on your phone that simplifies the process of adding tasks and checking them off, will ensure that the annoying but necessary to-dos are met and not forgotten between phone calls, questions from staff, and attempts to update your patients’ electronic health records.

This app—The Checklist—provides an easily accessible prepopulated list that can be tailored to reflect your specific compliance needs, clinical tasks, and allows you prioritize practice-focused tasks, assign them to specific members of the clinical team, and follow up to assure completion. This app offers a way to eliminate concerns about having to remember whether you’ve done all you need to remain in compliance, and meeting financial reporting requirements.A dashboard provides you with an overview of task status with push notification reminders to prompt completion of assigned actions. Find The Checklist in either IOS or android versions wherever you download apps.

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