The Virta Clinic is pleased to share preliminary 1-year analysis from our ongoing 2-year clinical trial being conducted in association with Indiana University Health Arnett. Virta Health is an online specialty medical clinic focused on reversing type 2 diabetes using continuous remote care and personalized lifestyle interventions such as a ketogenic diet.

The preliminary results were presented this week at the 77th annual meeting of the American Diabetes Association by Sarah Hallberg, DO, MS, Medical Director of Virta Health. While detailed results are embargoed until publication, we are proud to share information from the presentation’s abstract.

We sat down with Sarah Hallberg, DO, MS, Medical Director of Virta Health, to discuss the details.

Q: What were the demographics of the study sample in Virta’s clinical trial?

Hallberg:

We found it to be a population that those treating patients with diabetes are all too familiar with—middle-aged middle Americans with longstanding type 2 diabetes and co-morbidities and high starting BMIs. Our sample includes professionals and blue-collar workers and represents a range of socioeconomic levels. The average age at outset was 54, the average BMI was 41, and 67 percent were female.[1]

Q: Patients can be successful at lifestyle interventions for 10 weeks, but can they maintain that success out to one year?

Hallberg:

  • The sustained enrollment and patient adherence that we saw at 70 days was maintained—82 percent continued enrollment at the one-year mark.
  • Patient HbA1c improved further: 58% of patients in the Virta clinical trial achieved A1c below 6.5% at one year while taking no diabetes medications or metformin only.
  • Use of medications continued to drop: insulin was reduced or halted in 97% of users.
  • And body weight declined from baseline by an average of 13.6 percent. [2]

We believe that these results indicate that the Virta program is highly sustainable. That’s because it is such a high-touch model of healthcare delivery: patients receive continuous feedback and encouragement from their assigned health coaches via their smartphones; patients transmit key biomarkers to Virta daily, where the data is continuously reviewed in order to make real-time adjustments to their medication dosages and their treatment plans; we hear from patients that this level of connection to their health coaches, as well as connection with other Virta patients around the country, provides them with a positive level of accountability and motivation to stay on track.

Q: What is the Virta model for managing and reducing medications as patients’ blood sugar comes down?

Hallberg:
Based on the first 111 patients to finish a year in Virta, 97 percent of patients have eliminated or reduced their need for exogenous insulin. The number of prescribed medications for oral glucose control (excluding metformin) was reduced across the population from 51 at baseline to 8, an 84 percent reduction. [2]

We have a model wherein our Virta physicians and our health coaches review each patient’s biometrics daily—in some cases, around the clock—allowing the clinical team to adjust medication levels in real time, as the patients’ blood sugar levels change. This protects the patients from accidental overdose, as their need for medications can plummet rapidly as they implement lifestyle changes. Our clinical team communicates with patients by text message and phone calls to inform them immediately of any dosage changes.

Q: The Virta program includes a Low Carbohydrate-High Fat diet; what results are you seeing on patients’ cholesterol profiles?

Hallberg:
We see HDL go up and triglycerides go down: HDL-C went up statistically significantly, from an average of 46 to 53; Triglycerides went down from an average of 176 to 132, also a statistically significant amount. The newest science indicates that LDL-p is a key marker for risk of cardiovascular disease, and our results show LDL-p to be unchanged. [2]

Q: As principal investigator as well as a care provider for many Virta patients, what changes have you witnessed in patients’ lives?

Hallberg:
I love my job because I get to see people’s lives being transformed. I see people who have been ill for decades and who had given up all hope of regaining quality of life suddenly being able to live again. They can play with their grandkids. They can return to work and engage at a higher level than they have in years. Their energy returns, their sleep improves, their musculoskeletal pains resolve. I often hear that they feel 20 years younger. It’s gratifying to be a part of that.

 

Works Cited

1. McKenzie AL, Hallberg SJ, Creighton BC, Volk BM, Link TM, Abner MK, Glon RM, McCarter JP, Volek JS, Phinney SD. A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes. JMIR Diabetes. 2017;2(1):e5

2. Hallberg S, McKenzie A, Bhanpuri N, Volk B, Hazbun T, McCarter J, Phinney S, Volek J. Remote Care Promotes Low Carbohydrate Diet Adherence and Glycemic Control Allowing Medication Reduction in Type 2 Diabetes [abstract]. Diabetes. 2017; 66 (suppl 1a): LB