10 years. $2 Trillion. No improvement in T2D outcomes. What!?

JAMA Internal Medicine published a well done study about our national diabetes outcomes titled “Evaluation of the Cascade of Diabetes Care in the United States, 2005–2016” with a rather depressing conclusion: “Despite major advances in drug discovery and movement to develop innovative diabetes care delivery models over the past 2 decades, the diabetes care cascade did not appear to improve for US adults with diabetes between 2005 and 2016.” A decade with no improvements!

From JAMA Intern Medicine: No improvement in key diabetes related outcomes on population level from 2005 to 2016.

In other words, after about a decade and ~$2 Trillion spent on diabetes medical costs (estimate based on data from the American Diabetes Association), there was no quantifiable improvement in key diabetes-related outcomes. That is sad on too many levels and most importantly for the 30M+ Americans living with diabetes today.

* What do today’s diabetes care outcomes look like?

The success of a diabetes intervention is typically gauged on its ability to normalize a person’s blood sugar, measured by something called Hemoglobin A1c (or simply A1c). And on this measure, as a nation we are a mess. Despite $30 Billion per year spent on diabetes medications alone in the U.S., more than half of people with diabetes have blood sugar that is uncontrolled (A1c >7.0%) according to the Center for Disease Control’s 2020 National Diabetes Statistic Report. And things aren’t getting any better.

Blood sugar (A1c) levels among U.S. adults with diabetes — and no change from 2005 to 2016 — despite billions spent on diabetes drugs per year. Source: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

These national average A1c values are, unsurprisingly, quite comparable to those we saw in participants at the start of our prospective clinical trial at Virta Health, including those participants in the control arm. Those patients in the “control arm” received “regular” type 2 diabetes care — the very best of what was available — from primary care providers and endocrinologists in Indiana. Here are the 1-year results for these patients: these may look particularly bad (poorer glycemic control), but this is what happens when T2D is treated as a chronic, progressive disease even with a good approach to “diabetes management”.

Blood sugar (A1c) levels among patients in the control arm of Virta’s clinical trial, representing high-quality type 2 diabetes care (diabetes management). Results at start and at one year. It is typical that cohort results worsen (since T2D is a “progressive” disease) despite increased diabetes medications.

So, should we give up on our efforts to control our rapidly growing diabetes epidemic? After all, what more could we be doing? Today, we spend $300B per year on direct T2D medical costs in the U.S., including north of $30B on medications. Time to give up and save the money for something else? Fortunately, I believe there is still hope.

Population level improvement in type 2 diabetes outcomes — is it even possible?

Hypoglycemic drugs (i.e. those that target blood sugar) are expensive and come with a host of side-effects — some even deadly — but they do work in lowering blood sugar. Could we simply further intensify drug therapy and pump more diabetes drugs to deliver better glycemic control? In fact, that’s what we’ve tried for the last decade and more, but the primary quantifiable result is the increased cost of care, without improvement in population level outcomes as indicated by the JAMA Internal Medicine study. So that is hardly the best path forward.

But there might be a better way to deliver glycemic control, while also de-escalating pharmaceutical therapy (i.e. eliminating diabetes drugs). Here’s what we are seeing on a population level with Virta’s provider-led reversal treatment that is based on highly individualized nutrition protocols, intensive support and de-escalating drug therapy.

Blood sugar (A1c) improvement among Virta patients in a prospective clinical trial from start to one year, while de-escalating diabetes drug therapy. Source: https://pubmed.ncbi.nlm.nih.gov/29417495/

Indeed, it is possible to deliver substantially improved glycemic control at the population level. These results would be stunning even while intensifying drug therapy. The fact that they are achieved while de-escalating drug therapy substantially (over half of all diabetes-specific drugs were eliminated at 1 year) makes them transformative.

Our clinical trial results, fortunately, aren’t an exception. Below is an example from a large commercial customer whose population started with very poor blood sugar control, with >75% of starters having an A1c >7.0% (compared to about 50% with A1c >7.0% in the adult type 2 diabetes population nationally). Within just 6 months, population blood sugar control improved dramatically. Again, this occurred while simultaneously de-escalating pharmacological therapy.

Blood sugar improvement among Virta patients at a large commercial customer and very poor starting A1c. Source: Virta internal data**

The future of type 2 diabetes care?

The bottom line is that existing approaches to T2D have not worked, despite ever-escalating care costs. However, we have now shown a better way — in fact, one that is significantly better — to address our T2D epidemic even on a population level. These results are better for the patients, better for providers and better for payers who pay for the diabetes care costs. After a long, seemingly futile stretch with no improvement in population outcomes, we are optimistic that we are on the doorstep of making a real dent in our type 2 diabetes epidemic.

[**Footnote: Internal data is not published and peer-reviewed; this outcome data also does not represent drop-outs although our 1-year commercial population retention is comparable to our clinical trial’s 83%; Missing A1c lab values for this commercial population is estimated based on daily glucose measurements.]

Founder & CEO @VirtaHealth on a mission to cure irreversible diseases, Co-Founder @Trulia, Data Geek. 8h24min Ironman & Triathlon world champ (ag).

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