More on Dexcom: Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans was published by Ricky Zipp for MedTechDive.com, 7 June 2022.  

The executive spoke about the company’s discussions with the FDA on the G7 CGM system, possibly expanding from a 10-day to a 15-day sensor, and a report that Dexcom was in talks to buy Insulet.

When Dexcom quashed reports last week that it was in talks to buy Insulet, one key question still remained for the company: When would the G7 continuous glucose monitoring system be cleared for the U.S. market? Still, as the ADA conference wraps up this week, there still hasn’t been a decision from the Food and Drug Administration and Dexcom currently doesn’t have a timeline.  “We’re not there yet. We have more work to do,” CEO Kevin Sayer said in an interview. “I don’t have a date yet.”

In May 2022, there were reports of a potential Dexcom-Insulet deal. Can you talk about Dexcom’s overall approach to M&A and if an insulin pump company would ever be a potential acquisition?  SAYER: The only statement from us is we’re not merging or acquiring anybody. So, I will stick to that as far as the specific rumor, but I will talk about our strategy going forward and what we consider, and what we’ve done in the past.

Read more:  Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans

Lies, damned lies, and statistics. The art of the CGM accuracy study was shared by Tim Street for Diabettech.com, 17 May 2022.  

How do you compare two different CGMs? It seems like a stupid question. It’s obvious. You look at the Mean Absolute Relative Difference (MARD) of the two and the lower one is better. Right?  In theory. And yet, you might come away disappointed.  Everyone who uses CGM has asked themselves “How are my readings so different from the reported accuracy?” in some way.

At ATTD2022 this year, Boris Kovatchev stated that we shouldn’t be comparing AID systems that use different CGM systems.  A key takeaway is that MARD alone is not good enough to compare systems. And if that proves too much to read, then the message is, “We need a consensus on CGM accuracy studies”. 

Comparing accuracy studies:  Firstly, understanding the basis of the accuracy study for the sensor you’re looking at the summary of is not always easy. Secondly, clear information on many factors of the study is often missing.

Why does this matter?  If the methods used to capture the data and manage the participants are different, it can affect the variability of glucose levels and thus reported values. Similarly, selecting a population with the potential for lower variability may present a set of data that appears to have a lower MARD.  Roll in variability about the devices themselves, and you have a potential world of pain for a reader to sift through.

Conclusion: When comparing devices, the only way to minimize or eliminate factors that contribute to the non-concordance of each system is to conduct a head-to-head comparison when different ISF devices are worn simultaneously by the same subject and an appropriate, and identical, reference method is used.

Read more:  Lies, damned lies, and statistics. The art of the CGM accuracy study.

CGM Alarm Fatigue was written by Marissa Town for ChildrenWithDiabetes.com, 1 June 2020  

When you have a device that monitors your glucose levels as a person with type 1 diabetes, you are likely quite familiar with alerts and alarms. What happens when you stop hearing your alerts?   “Alarm fatigue,” which happens often to healthcare workers, can happen to us as T1Ds and carers, now that we have so many diabetes technologies. 

Ways to Minimize Alerts:

• • Raise the high alert to something realistic based on your glucose levels, but still safe
  • Turn the alerts off on the child’s or partner’s phone, and leave them on the caregiver of the T1D
  • Consider the use of a flash CGM or bed shakers instead of having alerts on devices, even if it’s just temporary
  • Turn off the rate of change alarms, especially for rising
  • Turn alerts on for only one device, as opposed to both if you use multiple devices

Everyone working with new diabetes technologies should seek to make alarms as safe and user-friendly as possible.

• • Manufacturers should continue to communicate with patients, families, and providers about how existing systems can best be used and how new systems can best be built.
  • Regulators should continue to prioritize human factors in their review of new products, they should keep in mind the tradeoffs between comprehensiveness and the risk of alarm fatigue, and they should consider the risks of current diabetes management practices when evaluating new technology (including alarm features), and they should encourage alarm-related innovation—especially in “training-wheels” environments such as inpatient studies.
  • More broadly, we believe that regulators should view alarms as tools to help patients manage their disease, not just as a safety net.
  • Researchers and engineers should consider the potential for alarm fatigue in their design and evaluation of experimental technologies. 

There is some innovation to make alarms more usable and noticeable.  One new product is called SugarPixel by CustomTypeOne.com.  Developed by Jon Fawcett, a dad of a T1D teenage daughter, this device seems to be gaining a lot of fans.

Use SugarPixel for…

• • Hard to wake teens and college students transitioning to independent care.
  • Vibration alerts for the hearing impaired and dual audio vibration alerts for heavy sleepers.
  • Displaying BG values from multiple T1D at the same time on a single device.
  • A quick glance from across the room or across the yard with the large display.

Read more:  

• • CGM Alarm Fatigue
  • SugarPixel by CustomTypeOne
  •  

Payers Failing to Follow Through on Prior Authorization Reforms was written by Jay Asser for HealthLeadersMedia.com, 2 June 2022.

Health insurers are not holding up their end of the bargain on mutually accepted prior authorization reforms, according to a new physician survey by the AMA.  Findings from the survey, which compiles the experiences of 1,000 physicians from December 2021, show that payers are not upholding a 2018 voluntary agreement between them, the AMA, and other national organizations representing pharmacists, medical groups, and hospitals.

The consensus statement highlighted five key prior authorization reforms to increase efficiency, promote access, and reduce administrative burdens.

• • One of the reforms focuses on encouraging the use of programs that selectively implement prior authorization requirements based on providers’ performance. However, only 9% of the physicians in the AMA survey reported contracting with insurers that offer programs that exempt providers from prior authorization.
  • 84% of physicians reported that the number of prior authorizations required for both prescription medications and medical services had increased over the past five years, running counter to the reform encouraging revision of prior authorization requirements.
  • 65% and 62% of physicians reported difficulty in determining whether a prescription medication or medical service, respectively, requires prior authorization.
  • The fourth reform outlined in the agreement centers on continuity of patient care, encouraging protections for patients during a transition period. Yet 88% of physicians reported that prior authorization sometimes, often, or always interferes with continuity of care.
  • Finally, only 26% of physicians reported that their electronic health record system offers electronic prior authorization for prescriptions, going against the agreement to reform automation to improve transparency and efficiency.

To combat the issue, the Seniors’ Timely Access to Care Act is set up to be considered by the House of Representatives after surpassing 290 co-sponsors.  The bipartisan legislation, which aims to improve prior authorization processes for Medicare Advantage plans, has widespread support.

Read more: Payers Failing to Follow Through on Prior Authorization Reforms

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