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New Diabetes Technology: Fact and Fantasy

Guest Post by David Kliff, Diabetic Investor

“Diabetes technology is evolving in a very exciting way,” said Jeff Dachis, CEO and Founder of One Drop. “But not surprisingly for the vast majority of people with diabetes worldwide, expensive sensors, automated insulin delivery solutions, or call center approaches to care can create barriers and challenges to effective disease management.” This statement came from a MannKind press release announcing a new clinical trial.

Per that same release:

“Appropriate people with type 2 diabetes who meet inclusion criteria will be randomized to one of two treatment arms: Afrezza® with One Drop | Premium — or — One Drop | Premium alone. Changes in hemoglobin A1C, quality of life, self-care, treatment satisfaction, and other metrics will be assessed. “

Now before we get into what’s really going on here I have a few quick thoughts about this trial. First, it is refreshing to see One Drop participate in a real randomized controlled clinical trial, as they have tended to use “self-reported” data to prove their system works. Two, I suspect that when this trial is over both groups will show various levels of improvements in HbA1c. As I keep saying Afrezza does work; this has never been in dispute. The problems with Afrezza have nothing to do with whether it works. Third, the results of this trial will do nothing to change the fortunes of MannKind or One Drop.

What I found interesting was Mr. Dachis’ choice of words, as he has drawn a line in the sand. “Expensive sensors, automated insulin delivery solutions, or call center approaches” could be seen as a slap in the face to Dexcom, Medtronic, Abbott, Insulet and Tandem, just to name a few. The statement is also inaccurate, but more in that in a moment.

Basically, what One Drop is trying to do is position themselves as the solution for patients with type 2 diabetes, patients who are not currently intensively managing their diabetes. One Drop is trying to outdo Livongo, another company big on “self-reported” data. Like Livongo they understand that payers don’t want to spend a fortune on these patients, which is why Mr. Dachis went after CGM and insulin pumps. His audience wasn’t patients with diabetes but payers.

As much as I admire what Mr. Dachis has done, there are several items here open to challenge.

“Expensive sensors”

At the moment, this is a semi-accurate statement as the One Drop system is “cheaper” than any CGM system. However, CGM provides better and more data than the One Drop system does, and patients with non-intensively managed diabetes hate conventional meters even when this data is analyzed. The fact is, Dexcom’s disposable sensor will cost the same as conventional test strips. Imagine that: better and more data at the same cost as an old outdated technology that patients already hate. Can the cloud enabled companies really compete with this?

“Automated insulin delivery solutions,” i.e. Insulin pumps

Pumps can be expensive, but non-intensively managed patients don’t use pumps–hence the term “non-intensively managed.” Nor do I feel these patients on a mass scale will use Afrezza either. The reality is One Drop first must convince these non-intensively managed patients they need insulin–not an easy task by any means. Next, they must navigate the payer world and convince payers that Afrezza is the insulin these patients need, another not so easy task. If they can successfully jump over these two huge hurdles they must then somehow get payers to increase their reimbursement for Afrezza, which seems unlikely.

The reality is if payers are going to move in any direction at all it will be the system we keep talking about–CGM/Smart Pen/App. The One Drop’s approach also ignores GLP-1 therapy and of course the biggest problem of all, getting these patients to take their meds. There is no upside for MannKind by taking a non-compliant patient and turning them into a compliant patient. And let’s be honest, the clinical trial setting never matches what happens in the real world. It will look good but it’s not scalable by any means, which is another huge problem with all these way-cool-whiz-bang cloud enabled companies.

“Call center approaches”

One Drop and Livongo both assume that these patients want to be engaged with their devices and/or smartphones; that they do not want to be called and given advice or coaching. The implication of the term “call center” is cold and impersonal, while the One Drop system is supposed to be warm and fuzzy.

As we noted earlier today many of the functions now performed by a CDE will be replaced by technology. It is also true that yes, the patient’s smartphone will become the hub of their diabetes management. Yet what One Drop ignores, what all these way-cool-whiz-bang cloud enabled companies ignore, is the why. What would motivate these patients who were previously unengaged with their diabetes management to all of a sudden turn them into engaged patients?

Now please do not insult my intelligence and 20 plus years in this business and tell me these patients care about outcomes. Do not further the insult and say that payers care about outcomes. This is all about bucks, who makes them, who spends them, and who saves them.

I admire Mr. Dachis’ chutzpah, but the facts get in the way of what may be just a fantasy.

Reprinted with Permission: David Kliff, Publisher, www.DiabeticInvestor.com