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Digitally delivered cognitive behavioural therapy successful in type 2 diabetes

Presented By
Prof. Marc Bonaca, University of Colorado, CO, USA
AHA 2022
Phase 3, BT-001

The BT-001 pivotal trial demonstrated that nutritional cognitive behavioural therapy (nCBT) delivered through a digital app persistently reduced haemoglobin (Hb)A1c levels in patients with type 2 diabetes. Furthermore, nCBT was safe and associated with reduced blood pressure, weight, and need for medication intensification, as well as improved patient-reported outcomes.

Prof. Marc Bonaca (University of Colorado, CO, USA) explained that core thoughts and beliefs in patients with type 2 diabetes lead to unhelpful behaviours, such as sedentary behaviour and unhealthy food choices, ultimately resulting in an aggravation of their condition [1]. CBT can help patients exit this vicious circle. “However, the problem with CBT, and nCBT in particular, is a lack of access,” said Prof. Bonaca. “It is expensive for patients to follow CBT and it is often hard to find an available therapist.”

To address this issue, Prof. Bonaca and his co-investigators assessed a digital app that delivers nCBT digitally through lessons and skill development. The BT-001 trial (NCT04886388) randomised 669 participants with type 2 diabetes to either the BT-001 app or a control app to assess the efficacy and safety of this novel tool. The primary efficacy endpoint was the mean change in HbA1c level from baseline after 90 days [2]. The principal safety outcome was adverse events (AEs). Prof. Bonaca presented the results after 180 days of follow-up [1].

At 90 days, the mean HbA1c level of patients in the BT-001 arm had been significantly reduced compared with that of patients in the control arm (-0.28% vs +0.11%; Δ 0.39; P<0.0001) [2]. After 180 days, the mean HbA1c level of participants in the BT-001 arm was even further reduced, with a sustained significant difference between the BT-001 and the control arm (-0.37% vs -0.08%; Δ0.29; P=0.01; see Figure). Notably, the mean HbA1C levels of participants in the control arm decreased as well, which could be explained by the significantly larger proportion of participants that needed pharmacological treatment intensification in the control group than in the BT-001 group (21% vs 14%; P=0.002). The number of lessons that participants followed in the BT-001 app was associated with the reduction in HbA1c level; the more lessons, the larger the reduction (P=0.017). The mean change in body weight (-5.5 vs -1.9 pounds; P=0.005) and mean change in systolic blood pressure (-4.7 mmHg vs -1.8 mmHg; P=0.042) favoured the BT-001 arm over the control arm. Moreover, the SF-12 physical component score and the PHQ9 depression score displayed better results for participants using the BT-001 app compared with controls (ΔSF-12 1.8; P=0.009 and ΔPHQ9 -0.83; P=0.009). Finally, after 180 days of follow-up, fewer treatment-emergent AEs (55% vs 42%; P<0.001) and serious treatment-emergent AEs (7% vs 3%; P=0.01) were observed in the BT-001 compared with the control arm.

Figure: Difference in HbA1c from baseline in BT-001 and control group until day 180 [1]

HbA1C, Haemoglobin A1C.


“nCBT delivered via a digital therapeutic app significantly and persistently reduced HbA1c, potentially providing a scalable treatment option for patients with type 2 diabetes,” concluded Prof. Bonaca.

    1. Bonaca MP, et al. Randomized, controlled trial of digital nutritional cognitive behavioral therapy in patients with type 2 diabetes mellitus: Primary outcomes of the BT-001 pivotal trial at 180 days. FS.08, AHA Scientific Sessions 2022, 05–07 November, Chicago, USA.
    2. Hsia J, et al. Diabetes Care. 2022; Oct 1. DOI: 10.2337/dc22-1099.


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