New Diabetes-Focused Digital Therapeutic Improves A1c, According to Company Data

The maker of a new prescription digital therapeutic says its product can help improve outcomes in one of the most common and costly chronic diseases in the United States.

Better Therapeutics announced positive results last month from its recently completed pivotal trial for BT-001, a prescription digital therapeutic that would be the first of its kind for patients with type 2 diabetes. The company says its cognitive behavioral therapy-focused product led to sustained improvement in A1c levels over the course of 6 months.

Frank Karbe, the company’s president and CEO, said the data show that the current paradigm of diabetes treatment needs improvement.

“The positive data from this trial serves as an important stepping stone towards our goal of bringing BT-001 to patients and physicians in need of new therapies, and entering the next phase of our growth as a commercial-stage company,” he said, in a press release.

According to data released by the company, the trial involved a nationally representative sample of 668 people with diabetes who had a mean baseline A1c of 8.1 The CDC sayss most people with diabetes should aim for an A1c of 7% or less. The trial population included people with multiple comorbidities and who are taking multiple diabetes medications; they had been diagnosed with diabetes 11 years prior, on average.

Half of the enrollees were given standard care, and half were given standard care with the addition of BT-001. The software is based on cognitive behavioral therapy. It is designed to help patients modify behaviors and eating habits associated with cardiometabolic diseases.

Among those receiving BT-001, the average drop in A1c was 0.3% at 90 days and 0.4% at 180 days. Half of the patients using BT-001 achieved clinically meaningful results, the company said, and among those patients the average drop in A1c was 1.3% at 180 days. In addition, the company said patients who did not use BT-001, but received only the standard of care, were more likely to have their medications increased.

The study showed that users who were more engaged with the app benefited more from it.

The company said it plans to file an application for de novo classification with FDA later this year. If approved, the classification would allow the company to begin marketing the product.

However, given the relative novelty of prescription digital therapeutics, the company must also work to boost awareness and create a market for the product.

In a conference call announcing the study data, company executives said they have been working on developing a commercialization plan and securing funding to bring the product to market. The executives said the company surveyed national and regional payers and pharmacy benefits managers, and 71% of the 14 people they surveyed expressed that they would “likely” cover a product like BT-001. Similarly, 88% of 25 providers surveyed said they would likely prescribe it.

In the conference call, Karbe said Better Therapeutics is working to make a strong economic case for their product in order to entice insurers to reimburse it once it hits the market.

“The health economics data we are now generating has the potential to give payers something they are excited about because of potentially reduced cost of care,” he said in the press release. “And most importantly this investigational new therapy may help millions of patients living with type 2 diabetes in a meaningful and durable way.”