FDA expands the approved use of Continuous Glucose Monitoring System

The Food and Drug Administration (FDA) has expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring system or CGM system, which could instantly replace fingerstick blood glucose testing for diabetes treatment decisions in diabetic sufferers 2 years of age and older.

In accordance to the regulatory agency, it is the 1st FDA-approved Continuous Glucose Monitoring system that can be utilized to make diabetes treatment decisions without confirmation with a conventional fingerstick test. Initially, the Dexcom system was cleared to complement—not replace—fingerstick testing for diabetes treatment decisions.

“The FDA works really hard to assist ensure that novel technologies, which can decrease the burden of daily disease management, are safe and precise," stated Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "However this system still requires calibration with 2 daily fingersticks, it removes the requirement for any extra fingerstick blood glucose testing in order to make treatment decisions.

“This might permit some sufferers to handle their disease more comfortably and may motivate them to have routine dialogue with their healthcare providers about the use of real-time continuous glucose monitoring in diabetes management," further added Gutierrez.

Dexcom’s G5 Mobile CGM System uses a small sensor wire inserted merely below the skin that continuously measures and monitors glucose levels, sending real-time results wirelessly every 5 minutes to a dedicated receiver and a compatible mobile device—like the Apple iPhone—running a mobile app. Additionally, alarms and alerts notify consumers when there are glucose levels above or below user-set thresholds.

While the system calculates glucose in fluid under the skin that must be calibrated almost 2 times each day using blood obtained from fingerstick tests, Nicholas Argento, MD, an endocrinologist, claims that extra daily fingerstick blood tests are generally no longer essential because unlike other CGS systems, results from the device can now be used straightly by sufferers to make diabetes treatment decisions without confirmation from a traditional fingerstick test.

“We have seen CGM come from something that was sort of novel and experimental to now actually being the standard of care,” further adds Argento, who has Type 1 diabetes and personally uses the Dexcom Continuous Glucose Monitoring system. “What this system does is reduce the number of fingersticks and increases their level of blood sugar control by motivating sufferers to take action in a safe, discrete, accurate, and timely way.”

Argento points out that in addition to individuals with Type 1 diabetes there are an increasing number of patients with Type 2 diabetes using the Dexcom G5 Mobile Continuous Glucose Monitoring System. He also makes the point that consumers of the system are capable to designate “followers” like family members with whom they can share the CGM data through the app.

“This is a key benefit in specific for parents with young kids and teenagers that are now starting to drive. The technology permits caregivers to have their back and serve as their backups,” in accordance to Argento, who serves as the medical advisor to the diabetes program at the Howard County General Hospital, a Johns Hopkins System hospital in Columbia, Md.

In making its decision to expand the approved use of the CGM system, the FDA verified data from 2 clinical studies during which there were no critical adverse events were reported, according to the regulatory agency.

Nevertheless, the FDA released a written statement that “risks associated with use of the system might involve hypoglycemia or hyperglycemia in cases where data provided by the device is wrong and utilized to make treatment decisions or where hardware or set-up issues disable alarms and alerts, as well as skin irritation or redness over the device’s adhesive patch.”

Moreover, the agency cautioned users that the system “must be calibrated utilizing a fingerstick blood sample at least once every twelve hours and that taking any medications containing acetaminophen while wearing the system might wrongly raise glucose readings.”

 

Healthcare contributor-related digital health news from Q1 2016

Major players in Q1: Apple, Harvard and Stanford

Apple had once again made few major declarations this quarter that should be on healthcare contributors' and medical researchers' radars. At a particular occasion in the month of March, Apple declared the inauguration of its new CareKit platform, as well as few new characteristics of Apple ResearchKit.

CareKit is a proposed open source toolkit for the several hospitals and health systems. It will start with 2 applications: 1 for home checking of Parkinson's and other for the post-surgical discharge.

Apple also declared that ResearchKit would be upgraded to more easily make utilization of clients' genetic data, through a module designed by consumer Genetics Company 23andMe. Apple added other modules for usual medical expermients to ResearchKit.

Apple declared 3 ResearchKit apps that will start including the genetic data, one recent app and 2 existing ones. PPD Act, led by the University Of North Carolina School Of Medicine, will utilize genetic data to seek the query of why postpartum depression affects certain females and not others. Stanford's MyHeartCounts app will involve information from 23andMe users who are already utilizing the app, to assist them to research the genetic predisposition toward the heart cases and how they interrelate to lifestyle and activity proponents. Mount Sinai's Asthma Health app, co-developed by LifeMap Solutions, will "utilize genetic data from 23andMe clients to assist the researchers better comprehend ways to personalize asthma treatment," in accordance to Apple.

Another more ResearchKit app that was declared during the quarter was TeamStudy, a ResearchKit application began by Harvard University and Sage Bionetworks that targets to accumulate information from previous NFL players as well as the general public to study and better comprehend the impact playing football has on expert athletes.

Boston Children’s Hospital, which is also linked with the Harvard, started a 2^nd ResearchKit app this quarter known as Feverprints. Individuals all around the United States of America will be capable to download Feverprints and contribute information about their temperature (both when ill and when well), their medication utilization, any symptoms they may have, and demographic information. From the de-identified, aggregate information, Hawkins hopes to learn 3 things: what the range of "normal" temperature is, either various ailments have identifiable temperature profiles, and either fever-decreasing medications actually make better the recovery period or merely treat symptoms.

2 hospitals also declared patient-generated health information projects that utilized Apple HealthKit. In the month of January, Beth Israel Deaconess shared reports about BIDMC@Home, a step the hospital has been working on for the past 6 months or so. The concentration will be on congestive heart failure and disease of hypertension and the devices utilized will be linked weight scales, as a proxy for fluid balance, and blood pressure monitors. Additionally, Stanford issued a study proposed to demonstrate how a Dexcom CGM, HealthKit, and Epic can be utilized collectively to make better the glycemic control in the time of teens and kids with Type 1 diabetes. We also learned that Epic is working on an Apple Watch app for contributors.

Stanford had an influential quarter. In regard to the ResearchKit app and the CGM research, Stanford started an Android version of its Stanford Health Care MyHealth application, which permits sufferers to view their medical information, check test results, pay medical bills, handle prescriptions, schedule the all doctor appointments, and consult with a physician through protective messages or through the video visits characteristics.

The hospital also joined hand with UK-based mental health contributor Mersey Care NHS Trust has joined with Stanford University to establish an app to stop suicide. When a person decides to utilize it, the conceptualized application will check their communications, like social media accounts, emails, and phone calls, to assist the physicians to detect those at threat of committing suicide. If clients show thr symptoms of touring a location where persons mostly commit suicide or if they just miss out a significant appointment, the application would notify the proposed clinicians who could then call the client then.

After that in the quarter, Stanford released a research in the Journal of the American Medical Informatics Association explaining their experience setting up continual glucose checking with a Dexcom G4 CGM, Apple HealthKit, and Epic. In spite of few technical complications, the technology was highly effective and convenient to utilize.

Boston Children’s also had a great quarter. In regard to the Feverprints research, BCH revamped its Innovation Accelerator program into a latest accelerator known as IDHA which compels on the work of about fifty hospital workers and hinted at a partnership in the works with the institute of Amazon to “embed Children’s Hospital know-how” in the Amazon Echo, the Bluetooth speaker of company that doubles as a voice control central hub for linked home devices and facilities.