Better Therapeutics Inc (BTTX)

[Frankestin]

https://www.liebertpub.com/doi/epdf/10.1089/dia.2024.2525.abstracts
RANDOMIZED, CONTROLLED TRIAL OF A NOVELDIGITAL THERAPEUTIC IN PATIENTS WITH TYPE 2DIABETES: BT-001 PIVOTAL TRIAL 180 DAYOUTCOMES
Background and Aims:BT-001 is a digital therapeutic in-tended to provide cognitive behavioral therapy to adults withtype 2 diabetes (T2D) through a mobile application (app). Safety,effectiveness and healthcare utilization were evaluated after 90and 180 days.
Methods:Adults with HbA1c‡7% were randomized (1:1) toaccess BT-001 or a control app. Both groups received standard ofcare. Treating clinicians were unblinded to HbA1c and allowedto adjust antihyperglycemic medication per guidelines.
Results:668 participants with a mean age of 58 years, HbA1cof 8.1%, 56% female, 29% Black and 16% Latino were enrolled.After 180 days, change from baseline in HbA1c was 0.4% in BT-001 participants, with a mean treatment difference betweengroups of 0.3% (LS Mean 0.28%, p=0.010), despite a significantincrease in medication use in the control group (p=0.025).Significant improvements in systolic blood pressure, weight,mood, and quality of life were also observed (p<0.05 for all).Adverse events were less frequent with BT-001 (p<0.001) withno adverse device effects reported.
Conclusions:Compared to standard of care treatment, BT-001 significantly reduced HbA1c at 180 days despite greaterintensification of medication use in the control group. Benefitsextended to other cardiometabolic factors including weight andblood pressure and were associated with fewer adverse events.These findings support the use of BT-001 as a safe and scalableadjunct to medical therapy in improving glycemic control andcardiometabolic markers in patients with T2D while also low-ering healthcare utilization.