Of the 262 patients with type 2 diabetes in the intervention, 83% stuck with it through the first year, despite significant requirements.
Patients with type 2 diabetes (T2D) who spent a year limiting carbohydrates—while their biomarkers were closely watched to keep them in a metabolic state to burn fat—showed sharp drops in glycated hemoglobin (A1C), weight, and medication use, according to results just published in Diabetes Therapy.
The treatment, developed by Virta Health, allowed 60% of those who completed 1 year of the program to reverse their T2D, meaning their A1C was below 6.5% without taking any glycemic control drugs except metformin. Overall, study participants’ A1C fell from an average of 7.6% to 6.3%, and their average weight loss was 12%.
At the start of the study, 92% of the T2D patients in the intervention group were obese, and 88% were taking medications for glycemic control. Of note, 94% of the intervention participants who were using insulin reduced their dose or stop using insulin. All sulfonylurea use stopped in this group. While this was not a randomized controlled trial, the researchers compared outcomes of the intervention group to those of a usual care group of 87 patients; 82% were obese and 87% were taking glycemic controlling medications. This group had no changes in A1C, weight, or medication use over the year.
Most of the 262 participants who took part in the intervention stuck with it for the full year (83%), despite some significant requirements. This was no ordinary “diet,” but an individualized effort for each person to reach nutritional ketosis, or a metabolic state in which the body produces ketones that can break down fat. To reach this stage, participants had to dramatically reduce their carbohydrate intake and be closely monitored. Daily blood tests measured blood glucose and betahydroxybutryate (or BHB), which evaluates ketones.
Medical researchers connected to each patient’s primary care physician monitored these tests to adapt each patient’s diet based on the results, and patients also received support from an online peer community.
The Virta treatment uses technology and artificial intelligence, along with close patient supervision, to change a patient’s diet to restore metabolic health while slowly eliminating medications. In a statement, the company said business partners such as Purdue University have found that using the program promotes a healthier workforce while achieving cost savings for each person who undergoes the treatment.
Sarah J. Hallberg, DO, MS, Virta medical director, is the lead author of the study, which first reported results at the 70-day mark last year. “Our approach is changing the diabetes care model,” Hallberg said. “With continuous remote care, we provide patients ongoing and immediate access to our clinical team, which is critical for both safe and effective reversal of type 2 diabetes, especially for patients taking medications.
“What’s exciting about this new data is both the sustainability of the outcomes and the improvements in other comorbidities, such as high blood pressure, inflammation, and heart disease,” said Sami Inkinen, CEO and co-founder of Virta Health. “I am more excited than ever about what this means for our current and future patients, not to mention the impact we can make on the economic burden of chronic disease as we scale towards our long-term goal of reversing type 2 diabetes in 100 million people by 2025.”
Other results for patients in the treatment group included, on average:
The authors acknowledged that the study involved mostly white, self-selected patients, and that a future randomized controlled trial should include a more diverse group of participants from multiple sites. Still, they wrote, their inclusion of patients already taking insulin and with longstanding T2D, who are often left out of such studies, speaks to the real-world possibilities of the Virta program.
No incidents of ketoacidosis, hypo- or hyperglycemia that required assistance, or other adverse events attributable to the intervention were reported. The authors said the program appears safe, with improvements or no change in liver, kidney, or thyroid function.
Hallberg SJ, McKenzie AL, Williams PT, et al. Effectiveness and safety of a novel care model for the management of type 2 diabetes at 1 year: an open-label, non-randomized, controlled study [published online February 7, 2018]. Diabetes Ther. doi: 10.1007%2Fs13300-018-0373-9.