We really thought we were passed this point but it’s time for a refresher course in glucose monitoring. Thanks to the coronavirus the FDA has been relaxing regulations on the usage of glucose monitoring in a hospital setting. The FDA has granted Livongo emergency use authorization to allow its glucose meter in a hospital. It has also granted this authorization to Dexcom and Abbott for their CGM systems.
As we noted just yesterday the coronavirus is breaking down barriers and telemedicine is huge beneficiary. Besides Dexcom, Abbott and Livongo nearly every glucose meter whether it is continuous or conventional is now cloud enabled allowing for readings to be shared via a cellphone.
Given the demands on hospital staffs during this crisis no one should be shocked that the FDA has moved in this direction. Nor is this the first time CGM usage has been tired in a hospital setting. We have to go way back in the wave back machine but in the very early days of CGM it was thought it could be used as a tool to help get patients out of the ICU quicker thus saving the hospital and payors money. Just Google the Portland Protocol and you’ll see what we’re talking about.
Fast forward to the current crisis and the fact that patients with diabetes are disproportionally impacted by the virus and it makes perfect sense that the FDA would grant these emergency authorizations and likely will make these temporary changes permanent once the crisis is over. Simply put the FDA wants to make it easier for the hospital to track a patient’s glucose readings. Now that every glucose monitoring system is cloud enabled the hospital staff can spend less time gathering this data and more time on taking care of patients with the virus.
Gathering this data can be done in one of two ways. Once in the hospital the staff can slap on a CGM sensor such as the G6 from Dexcom or Libre from Abbott and have the ability to track a patient’s glucose data continuously for either 10 days or two weeks. Neither system requires calibration, both send data to a smartphone and insertion is simple and relatively painless. Even better these system are reliable and deliver accurate glucose data. More accurate actually then a conventional finger stick monitor.
The other option is using a conventional finger stick monitor such as the one used by Livongo patients. While we would not say these finger sticks are painful, they sure aren’t pleasant either. (It’s no accident that both Dexcom and Abbott when advertising their systems on TV note that neither system requires a patient to prick their fingers. ) These conventional finger stick monitors deliver one reading at a time meaning that either the patient or hospital staff member must perform the test over and over to get a true picture of how the patient is doing.
It’s been awhile since we have seen any data, but it should be noted that there is a great deal of variance when it comes to conventional finger stick monitors. The last time we looked which granted was a few years ago there could be as much as a 20% variance between what the monitor says the glucose value is and what it really is. Again taking a trip down memory lane there was a time when LifeScan then the leader in glucose monitoring made a huge deal out of the fact their monitors where more accurate than the competition. To be fair we have no idea how accurate the Livongo device is but based on what we know about the G6 and Libre these systems are more accurate.
Yet accuracy is only part of the picture as to why CGM is a much more efficient option for a hospital. As you may have guessed this comes to money and specifically in a hospital setting time is money and time is not a renewable resource. Using an old-fashioned finger stick monitor such as the one provided by Livongo takes too much time as it only records one reading at a time and this is not enough data to get an accurate picture of how the patient is doing. Either the patient or hospital staff must repeat this test several times per day to get an accurate assessment of how the patient is doing.
Based on efficiency alone CGM beats conventional old-fashioned finger stick monitors. The sensor need only be inserted once and data flows for 10 days to two weeks. Simply put when you add in the time factor CGM is much more efficient and efficiency in a hospital setting saves time and time in this setting equates to money.
CGM also provides a much more accurate assessment of how the patient is doing based on the simple fact it collects data on a continuous basis. There is a plethora of study data that proves that a patient’s time in range is as important or more so than single readings gathered every few hours. This is the reason TIR – time in range – is quickly becoming a key metric for measuring control.
Now none of this should be news to anyone these facts have been known for some time. Hence the reason CGM is becoming the standard for glucose measurement replacing the old fashioned outdated BGM systems of the past. But during a time of crisis companies like Livongo won’t let facts get in the way of a good story especially when that story helps increase the value of their shares.
As we have noted many times Dexcom and Abbott will definitely benefit from this move into the hospital. Livongo on the other hand will do what they always do and make a big deal out of what really is a non-event. As Joe Pesci who played Nicky Santoro in the great movie Casino said and it applies to Livongo so well as it’s how they think – “Always the dollars.” Not the dollars earned from the sale of their system, but dollars tacked onto their share price.