DXCM | FIELD NOTES ON CONTINUOUS GLUCOSE MONITORING

We conducted three interviews with domain experts on continuous glucose monitoring this past week.  All of them corroborated our view that the primary market for CGM is tied closely to Type I and Type II intensive insulin users and that a role in the general population of Type II patients will be severely restricted for some time. A key point is the cost of CGM as compared to strip based testing, as well as the restricted access patients already experience for this inexpensive alternative.  We did hear from a patient counselor that some Type II patients are paying for Freestyle Libre (not Dexcom) out of pocket for intermittent monitoring, but the cost is prohibitive for most.   The addressable market is best described as diabetics, either Type I or Type II, on multiple insulin injections per day and in the care of an endocrinologist.  Given that criteria, we should be able to estimate TAM using available data.  Peak market penetration for CGM is thought to be 60% of Type I and insulin intensive Type II patients, although cost is a significant barrier to getting there.

• "In my last role I led medical efforts in the development of a “continuous glucose monitoring device” 
• "A highly fractured and disorganized market in the glucose monitoring space"
• "Pharma spent years detailing against checking sugar, that their drugs did not require testing"
• There are approximately 1.3 million Type I, and 2.5-3.0 million patients if you include Type II on multiple injections of insulin per day"
• The cost basis to compare CGM to is strip based testing, which is significantly cheaper
• Managed care limits testing to 30 strips per month, and there is some restrictions that are hold overs from fraud/waste/abuse problems of the past
• All the evidence for the use of CGM is for patients on multiple daily dosing of insulin
• The larger opportunity in Type II is "probably never going to come to fruition"
• No evidence that CGM improves the outcome vs strips
• The analysis is complicated by multiple factors including patient compliance on diet, exercise, and medication targets
• There is utility for glucose testing in helping adjust a patient drug regimen, but continuous monitoring is not necessary, but it may help
• Only 10% of patients are cared for by a specialist, the more likely site of care for a patient to be on CGM
• There is "no doubt" about the value of HbA1C; more area under the curve, the longer patients has high sugar, the worse the patient outcomes
• "A couple of failed studies, not a failed hypothesis"
• The analysis of those studies is flawed
• Lower A1C leads to lower events, lower mortality and morbidity
• ACCORD study in June 2008 complicated the hypothesis
• Does CGM help lower A1C? That is the question that needs to be answered
• People are recently coming back to A1C in the literature
• But does CGM help control A1C? "That is a high hurdle and a very large study to prove" that CGM will help control A1C
• CGM is restricted to insulin intensive regimens, but intermittent testing may be part of the solution longer term for broader patient population
• The study that could show a patient benefit from CGM would be very large, and the signal would likely get "lost in the noise" given the regimen variation and patient compliance issues
• Medications are adjusted to impact A1C and CGM can't help you, although it may change behavior
• Use of CGM "comes down to patient preference"
• Alarm fatigue, too much information, patients balance the burden of the information and the benefits
• The "genius" of Libre is they re-purposed the sensor, built a new communication unit, and the patient swipes for an update
• The patient is not "drowning in data", ABT simplified the device
• Simple is better, and making the right decision is best
• Fraud was a big negative in the past and led to current restrictions for strip based testing
• CGM may have a role in helping a physician conduct a profile for intermittent data on M/W/F fasting, meal time, bedtime measures
• There is "no consistent voice to help the payors to best use the tools available"
• "Libre 2 does not change anything"
• "alarm fatigue" is a significant issue
• The market strategy has been that "anyone on insulin should be on a pump"  and "anyone on a pump should use CGM" but only 50% of pump users (Medtronic) use CGM
• Eventual market penetration at 60% for type I + type II insulin intensive
• Reasons for use are 1) prevent hypoglycemia 2) control A1C 3) improve the patient quality of life
• "Closed loop belongs in research skunk works and with the KOLs, it is mostly noise and does not address the top three issues why patients use CGM"
• I have not heard about patients "hacking the devices" to extend use and lower cost

Thomas Tobin
Managing Director


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Emily Evans
Managing Director – Health Policy



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