FDA Clearance Requested for Behavioral Diabetes Therapy

(Peejhunt, Pixabay)

22 Sept 2022. A digital health company is asking for FDA authorization to market a mobile app that helps treat type 2 diabetes with cognitive behavioral therapy. The app code-named BT-001 is made by Better Therapeutics Inc. in San Francisco, a developer of prescription digital software with treatments for cardiovascular and metabolic disorders.

Better Therapeutics says it applies principles of cognitive behavioral therapy to type 2 diabetes and several cardiovascular and metabolic conditions including nonalcoholic fatty liver disease, nonalcoholic steatohepatitis or NASH, hypertension, and hyperlipidemia. Type 2 diabetes is the most common form of diabetes affecting 90 to 95 percent of people with the disease, which translates to about 37 million people in the U.S. In people with type 2 diabetes, cells in the body do not properly respond to the hormone insulin that transforms glucose or sugar in the blood to energy. If left untreated, type 2 diabetes can lead to serious complications, including heart disease, vision loss, and kidney malfunctions.

Cognitive behavioral therapy or CBT is a form of psychotherapy where a clinician helps a patient verbalize and identify harmful patterns of thoughts and actions, then guide the patient through actions to develop healthier behaviors. CBT often involves testing and restructuring false or negative feelings or beliefs. Better Therapeutics says its software is designed to address cognitive patterns and behaviors associated with diet and associated lifestyle choices. The company says its BT-001 mobile app is the first digital CBT-based therapy for type 2 diabetes delivered directly to patients, without the need for a psychotherapist. However, the app is prescribed to patients by a physician as part of an overall program to treat their type 2 diabetes.

Declines in HbA1c levels at 90 and 180 days

Better Therapeutics tested BT-001 in a late-stage clinical trial, which enrolled 668 individuals age 18 to 75 with type 2 diabetes at six sites in the U.S. Participants in the trial were randomly assigned to use the BT-001 app along with standard medical care for type 2 diabetes, or standard care alone. The study team looked primarily for changes in hemoglobin A1c, or HbA1c, the standard measurement for concentration of glucose attached to hemoglobin in the blood after 90 days, between the two groups. The researchers then tracked participants’ HbA1c levels for another 90 days.

The company released results of the trial on 28 July, reflecting 180 days of data. The findings, published on the Better Therapeutics web site and not peer-reviewed, indicate HbA1c levels declined more for participants using BT-001 plus the standard type 2 diabetes care at both 90 and 180 days, compared to participants receiving standard care alone. The differences in HbA1c levels were large enough for statistical reliability. Plus, more participants receiving standard type 2 diabetes care alone needed to use additional medications to control their blood glucose levels than participants also using BT-001. In addition, participants in the BT-001 group experienced fewer adverse effects, including serious adverse effects, during the trial than participants receiving standard care alone.

Better Therapeutics is asking for the Food and Drug Administration to authorize marketing of BT-001 under the agency’s De Novo classification pathway. The De Novo classification pathway is reserved for new types of medical devices rated at low or moderate risk, where no other comparable devices or systems yet exist.

“As the first digital therapeutic submitted to the FDA for the treatment of type 2 diabetes,” says Better Therapeutics chief medical officer Mark Berman in a company statement, “BT-001 marks a new kind of treatment paradigm with the potential to address the root causes of this and other cardiometabolic diseases.”

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