Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial

Abstract

Background The prevalence of type 2 diabetes (T2D) continues to rise in the United States and worldwide. Cognitive behavioral therapy (CBT) has been shown to improve glycemic control in patients with T2D, but broad implementation has been limited by inherent access and resource constraints. Digital therapeutics have the potential to overcome these obstacles. Hypothesis To describe the rationale and design of a trial evaluating the efficacy and safety of a digital therapeutic providing CBT to improve glycemic control in adults with T2D. Methods This randomized, controlled, multicenter, Phase 3 trial evaluates the hypothesis that BT‐001, an investigational digital therapeutic intended to help patients with T2D improve their glycemic control, on top of standard of care therapy, will lower hemoglobin A1c (HbA1c) compared to a control app across a broad range of patients in a real‐world setting. The study is designed to provide evidence to support FDA review of this device as a digital therapeutic. The intervention is provided within the digital application (app) and includes no person‐to‐person coaching. The primary endpoint is the difference in HbA1c change from baseline to 90 days for BT‐001‐allocated subjects compared with those assigned to the control app. Safety assessment includes adverse events and adverse device effects. The study incorporates pragmatic features including entirely remote conduct with at‐home visits for physical measures and blood sample collection. Conclusions This randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable treatment option for patients with T2D.

Cost-Effectiveness Analysis of a Prescription Digital Therapeutic in Type 2 Diabetes

“…1 . Patient-level data for BT-001 plus SoC versus SoC alone was sourced from the BT-001 RCT [ 14 ] and was used to assign patient characteristics at baseline. Patient characteristics included demographics (e.g., age, sex, ethnicity), patient behaviors (e.g., smoking status), disease history (e.g., myocardial infarction, stroke, blindness), and other clinical variables (e.g., HbA1c, systolic blood pressure [SBP], body mass index [BMI], low-density lipoprotein [LDL], duration of diabetes).…”

“…The population in the model comprised 610 patients to match the intention-to-treat (ITT) population of the BT-001 RCT. The ITT population included participants who completed onboarding into the assigned treatment and had an HbA1c at the day 90 study time point [ 14 ], and was the primary source of demographic and patient history data (Table 1 ). Variables required for risk estimation that were not collected in the BT-001 RCT were derived from National Health and Nutrition Examination Survey (NHANES, 2017–2020) data, filtered to identify patients with T2D and HbA1c between 7% and 11% ( n = 593), in line with the trial population [ 16 ].…”

“…Mean changes in HbA1c, weight, SBP, and Patient Health Questionnaire-9 (PHQ-9) at day 90 and day 180 from the BT-001 RCT were used to define short-term efficacy (Table 2 ) [ 14 ]. Beyond the first year, time-varying risk factors including HbA1c, SBP, LDL, body weight, smoking status, and occurrence of severe hypoglycemia and symptomatic hypoglycemia were modeled using published equations [ 20 ].…”

“…Net annual insulin acquisition cost was derived from the Red Book [ 25 ] and adjusted using patient weight where necessary. Net annual total SoC costs for each drug class were derived on the basis of the wholesale acquisition cost of each drug within each class (from the Red Book [ 25 ]), dosing (sourced from prescribing information for each drug), and frequency of use in patients with T2D (from the BT-001 RCT [ 14 ]) (Supplementary Tables 1 and 2).…”

Cardiology in a Digital Age: Opportunities and Challenges for e-Health: A Literature Review

“…E-health is also being used to telemonitor and limit relevant risk factors for cardiovascular diseases such as diabetes. For instance, one American trial [ 18 , 19 ] aimed to assess the efficacy and safety of a digital therapeutic application delivering cognitive behavioral therapy designed to improve glycemic control in patients with type 2 diabetes. The positive results demonstrated how digital therapeutics might provide a scalable treatment option for patients.…”