Evidence for changing the way type 2 diabetes is treated

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VirtalogoA Virta Health study shows that its novel metabolic and continuous remote care model can support adults with type-2 diabetes to safely improve glycosylated haemoglobin (HbA1c), weight, and other biomarkers, while reducing diabetes medication use.

Virta Health has announced the publication of 1-year results from its ongoing clinical trial, now 2.5 years in duration.

According to a Financial Times Company Announcement report, the study by researchers at Indiana University Health, Virta Health, San Francisco, the Keck School of Medicine, University of Southern California, Purdue University, Washington University in St Louis School of Medicine and The Ohio State University, augments Virta Health’s existing body of peer-reviewed research, which proved that the Virta Treatment could systematically reverse type 2 diabetes in as little as 10 weeks.

Newly released data demonstrates that diabetes reversal rates are sustained and in fact improved at one year, while metrics of other chronic conditions, such as obesity, blood pressure, cardiovascular disease and inflammation, are also substantially improved.

“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.”

By combining highly-individualised nutritional ketosis, medical supervision, and innovations in technology and artificial intelligence, the Virta treatment helps people eliminate medications safely and sustainably while simultaneously lowering blood sugar and restoring metabolic health. Virta’s continuous remote care model – near real-time access to physicians and other clinical team members via a mobile device – reinvents diabetes treatment to allow for scale to millions of people.

The report says enterprises such as Virta customer Purdue University, are benefitting too by promoting a healthier workforce and experiencing significant savings for each employee receiving the Virta Treatment.

“Our approach is actually changing the diabetes care model,” said Dr Sarah Hallberg, Virta medical director and principal investigator of the study. “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.”

The report says the study evaluates health outcomes after one year for 262 adults with diagnosed type 2 diabetes who received the Virta Treatment, and an additional 87 adults with type 2 diabetes who received usual care from their doctors and diabetes educators.

Key findings of the Virta Treatment group at one year include: 60% of those completing one year had type 2 diabetes reversed (HbA1c < 6.5% while taking no glycaemic control medications or only metformin); 83% remained enrolled in the trial; 94% of insulin users reduced or stopped usage altogether; participants experienced 1.3% average reduction in HbA1c (while reducing or eliminating medications); participants achieved 12% weight loss on average; and usual care participants had no significant changes to HbA1c, weight or diabetes medicine use.

With the Virta Treatment, however, results go beyond blood sugar and obesity reduction and included the following statistically significant changes: 24% decrease in triglycerides; 18% increase in HDL-C (‘good’ cholesterol); 39% decrease in C-reactive protein (a marker of inflammation); and decrease in both systolic and diastolic blood pressure.

“The continued improvement experienced by Virta Health patients, combined with the safety of the Virta Treatment, not only provides hope for those living with type 2 diabetes, but also for those with other chronic metabolic diseases,” said Dr Ethan Weiss, associate professor of medicine at the University of California San Francisco and a member of the Cardiovascular Research Institute (CVRI). “As a physician, I hear from my patients that they are desperate for ways improve their health. The Virta Treatment gives them the chance to actively reduce disease burden while also reducing medications. This is highly unusual.”

 

Abstract
Introduction: Carbohydrate restriction markedly improves glycemic control in patients with type 2 diabetes (T2D) but necessitates prompt medication changes. Therefore, we assessed the effectiveness and safety of a novel care model providing continuous remote care with medication management based on biometric feedback combined with the metabolic approach of nutritional ketosis for T2D management.
Methods: We conducted an open-label, non-randomized, controlled, before-and-after 1-year study of this continuous care intervention (CCI) and usual care (UC). Primary outcomes were glycosylated hemoglobin (HbA1c), weight, and medication use. Secondary outcomes included fasting serum glucose and insulin, HOMA-IR, blood lipids and lipoproteins, liver and kidney function markers, and high-sensitivity C-reactive protein (hsCRP).
Results: 349 adults with T2D enrolled: CCI: n = 262 [mean (SD); 54 (8) years, 116.5 (25.9) kg, 40.4 (8.8) kg m2, 92% obese, 88% prescribed T2D medication]; UC: n = 87 (52 (10) years, 105.6 (22.15) kg, 36.72 (7.26) kg m2, 82% obese, 87% prescribed T2D medication]. 218 participants (83%) remained enrolled in the CCI at 1 year. Intention-to-treat analysis of the CCI (mean ± SE) revealed HbA1c declined from 59.6 ± 1.0 to 45.2 ± 0.8 mmol mol−1 (7.6 ± 0.09% to 6.3 ± 0.07%, P < 1.0 × 10−16), weight declined 13.8 ± 0.71 kg (P < 1.0 × 10−16), and T2D medication prescription other than metformin declined from 56.9 ± 3.1% to 29.7 ± 3.0% (P < 1.0 × 10−16). Insulin therapy was reduced or eliminated in 94% of users; sulfonylureas were entirely eliminated in the CCI. No adverse events were attributed to the CCI. Additional CCI 1-year effects were HOMA-IR − 55% (P = 3.2 × 10−5), hsCRP − 39% (P < 1.0 × 10−16), triglycerides − 24% (P < 1.0 × 10−16), HDL-cholesterol + 18% (P < 1.0 × 10−16), and LDL-cholesterol + 10% (P = 5.1 × 10−5); serum creatinine and liver enzymes (ALT, AST, and ALP) declined (P ≤ 0.0001), and apolipoprotein B was unchanged (P = 0.37). UC participants had no significant changes in biomarkers or T2D medication prescription at 1 year.
Conclusions: These results demonstrate that a novel metabolic and continuous remote care model can support adults with T2D to safely improve HbA1c, weight, and other biomarkers while reducing diabetes medication use.

Authors
Sarah J Hallberg, Amy L McKenzie, Paul T Williams, Nasir H Bhanpuri, Anne L Peters, Wayne W Campbell, Tamara L Hazbun, Brittanie M Volk, James P McCarter, Stephen D Phinney, Jeff S Volek

Financial Times report
Diabetes Therapy abstract
Purdue University material
Virta study outcomes


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