1. What is the decision or change (e.g., clinical topic, practice guideline, system design, delivery of care) you are facing or struggling with where a summary of the evidence would be helpful?

We urge the agency to review the latest body of evidence supporting the use of nutrition-based approaches to treat individuals with Type 2 diabetes (T2D) and prediabetes. We specifically ask you to evaluate the impact of low- and very low-carbohydrate diets, designed to induce nutritional ketosis, in order to reverse T2D and prediabetes with the goal of achieving remission.

In the last 20 years, the number of adults in the US diagnosed with diabetes has more than doubled, with significant increases in the number of Americans with prediabetes. Nearly one in two Americans aged 18 or over suffer from diabetes (37.3 million) or pre-diabetes (96million), including tens of millions who are undiagnosed or unaware that they are inching toward a diagnosis. Further, diabetes represents growing problem in the United States that disproportionately affects minority populations.

It is clear that primary prevention, while important, is not sufficient to change the trajectory of US diabetes trends. It is critical to pursue more effective and sustainable efforts to treat and even reverse the condition. Adverse health effects of diabetes are significant, with uncontrolled blood sugar contributing to preventable stroke, kidney disease, diabetic retinopathy, amputations and death. The total economic impact of diabetes is now estimated to cost more than $400 billion annually.

Virta Health, through a five-year clinical trial and real-world registry data collected from Virta’s participation in more than 250 commercial health plans, has demonstrated consistent, durable reduction of HbA1c levels, de-prescription of diabetes medications, clinically significant weight loss and other health improvements associated with carbohydrate restriction and use of continuous remote care (remote monitoring and unlimited access to clinicians and coaches).

Specifically, results from Virta’s clinical trial showed that 94% of patients on insulin who remained under care for one year reduced or eliminated their dosage, including 60% who met the criteria for diabetes reversal by achieving an HbA1c below 6.5% without glycemic medications (with the exception of metformin). Notably, these patients also achieved an average weight loss of 12% and experienced significant improvements in biomarkers for cardiovascular disease, inflammation and liver function.

2. Why are you struggling with this issue?

While primary prevention remains important, the statistics show that too many people already suffer from diabetes. Conventional wisdom, even among many clinicians, is that Type 2 diabetes is progressive and chronic. Many patients and providers simply hope to manage the condition in order to slow decline. However, research is accumulating to show that the condition can reliably be reversed and remission can be achieved through nutritional changes. Moreover, despite the demonstrated effectiveness of the very low carbohydrate and nutritional ketosis approach for T2D and the recent international consensus surrounding diabetes remission as recognized by the American Diabetes Association (ADA), the Endocrine Society, the European Association for the Study of Diabetes and Diabetes UK, this approach has yet to obtain any formal endorsement from U. S. health agencies or broader adoption among the major medical organizations. Conducting a comprehensive review of current research and disseminating results will help educate providers, patients, payors and policy makers.

3. What do you want to see changed? How will you know that your issue is improving or has been addressed?

More effective treatment of T2D and prediabetes must be an integral part of efforts to address health equity challenges and improve the health of tens of millions of Americans. This should include guidance supporting the utilization of carbohydrate restriction for patients with T2D or prediabetes to encourage reduction of HbA1c levels, clinically significant weight reduction, and the reduction or elimination of diabetes medications as determined in the appropriate clinical setting.

4. When do you need the evidence report?

Wed, 03/15/2023

5. What will you do with the evidence report?

An AHRQ evidence report will serve to inform millions of patients, clinicians, public health officials and payors of the latest available treatment options for diabetes, specifically those that can improve health and generate savings without the use of medications or surgery. As we consider the full continuum of options for diabetes related care, patients deserve a full review of their options, particularly those with demonstrated effective approaches and results, such as achieving nutritional ketosis through the use of a low carbohydrate approach with proper supportive care and monitoring.

With respect to timing, given the number of lives at stake and current interest in addressing health equity issues, it would be ideal to have at least preliminary or directional findings as soon as practicable.

Supporting Documentation

AHRQ Evidence Request Literature Addendum (Word, 29 KB)

Optional Information About You

What is your role or perspective? Provider organization

If you are you making a suggestion on behalf of an organization, please state the name of the organization Virta Health

May we contact you if we have questions about your nomination? Yes