Change in Glycemic Control With Use of a Digital Therapeutic in Adults With Type 2 Diabetes: Cohort Study

Berman, Mark A; Guthrie, Nicole L; Edwards, Katherine L; Appelbaum, Kevin J; Njike, Valentine Yanchou; Eisenberg, David M.; Katz, David L.

doi:10.2196/jd.v3i1.9591

Cited by 6 publications

(12 citation statements)

References 27 publications

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“…We found that the intervention led to a 0.36 reduction in the average number of monthly outpatient visits per patient and a 0.38 reduction in the average number of monthly diabetes medication fills over the 5‐month period. The 34.5% reduction in diabetes medication fills from the baseline (preapplication period) is similar to that reported by other virtual diabetes programmes, in which declines in medication usage are in the 5%‐40% range 4‐7,10 . Savings attributable to the reduction in diabetes‐related medications were approximately $35 per patient per month, which represents approximately 10% of the monthly programme cost.…”

Section: Discussionsupporting

confidence: 77%

“…Reductions of this magnitude are considered clinically meaningful by clinicians and regulatory agencies 23 . Other named diet virtual programmes that advocate the restriction of certain foods or macronutrients report short‐term HbA1c reductions in the range of 0.8%‐1.1%, although there is substantial variation in the strengths of study designs 3‐5,12 . Named virtual diet programmes that promote healthy eating based on national dietary guidelines, national diabetes guidelines or caloric restriction either report no impact on HbA1c or reductions of up to 0.6%‐0.9% 6‐11 .…”

Section: Discussionmentioning

confidence: 99%

“…Lifestyle interventions and medical nutrition therapy are cornerstones of non‐pharmacological treatment for patients with diabetes. In particular, some virtual diet interventions with coaching components have been shown to be effective in achieving short‐term weight loss and improving glucose control, 3‐11 although less is known about the impact of coaching programmes with a specific ketogenic (keto) diet component 12 . One virtual diabetes coaching programme with a keto diet component has been previously evaluated.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference‐in‐differences analysis

Strombotne

Lum

Ndugga

et al. 2021

Diabetes Obesity Metabolism

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Aim To test the effectiveness of a ketogenic diet and virtual coaching intervention in controlling markers of diabetes care and healthcare utilization. Materials and Methods Using a difference‐in‐differences analysis with a waiting list control group—a quasi‐experimental methodology—we estimated the 5‐month change in HbA1c, body mass index, blood pressure, prescription medication use and costs, as well as healthcare utilization. The analysis included 590 patients with diabetes who were also overweight or obese, and who regularly utilize the Veterans Health Administration (VA) for healthcare. We used data from VA electronic health records from 2018 to 2020. Results The ketogenic diet and virtual coaching intervention was associated with significant reductions in HbA1c (−0.69 [95% CI −1.02, −0.36]), diabetes medication fills (−0.38, [−0.49, −0.26]), body mass index (−1.07, [−1.95, −0.19]), diastolic blood pressure levels (−1.43, [−2.72, −0.14]), outpatient visits (−0.36, [−0.70, −0.02]) and prescription drug costs (−34.54 [−48.56, −20.53]). We found no significant change in emergency department visits (−0.02 [−0.05, 0.01]) or inpatient admissions (−0.01 [−0.02, 0.01]). Conclusions This real‐world assessment of a virtual coaching and diet programme shows that such an intervention offers short‐term benefits on markers of diabetes care and healthcare utilization in patients with diabetes.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference‐in‐differences analysis

Strombotne

Lum

Ndugga

et al. 2021

Diabetes Obesity Metabolism

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“…The latter entities are used in monitoring and obtaining health data in the presence or absence of clinical evidence and varying regulatory conditions [3]. DTx are offered through web-based portals and/or smart phone applications, enabling patients to remotely access healthcare and actively involve themselves in the management of their clinical condition [4,5]. DTx treatment models have been widely adopted in management of various behavioral, psychological, metabolic, neurologic, cardiac, respiratory, and connective tissue disorders [6].…”

Section: Introductionmentioning

confidence: 99%

Changing face of healthcare: digital therapeutics in the management of diabetes

Ramakrishnan¹,

Yan²,

Balijepalli³

et al. 2021

Current Medical Research and Opinion

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Diagnosis, prevention, management and treatment of acute and chronic medical conditions have improved with technological advancements in terms of scalability, efficacy, access, and personalized approach. Digital therapeutic applications (DTx) (Blue Star®, Diabeo® System, Livongo Diabetes Program, Tidepool etc.,) use web-based applications/cloud platforms to provide evidence-based, personalized, rapid point of care management of chronic, behavior-modifiable conditions, including diabetes mellitus (DM). DTx has improved patient compliance, therapeutic success and economic outcomes in DM management by enabling active patient engagement, lifestyle change, comprehensive medical care, and periodic monitoring of glycemic status. Addressing concerns along DTx data vulnerability, comparative efficacy with conventional treatments, ability to accommodate diverse population needs, and resolving ambiguous regulatory policies and reimbursement guidelines are critical for increasing access to DTx, and overcoming availability, accessibility, and affordability issues in the existing resource limited healthcare environment. In this commentary theA c c e p t e d M a n u s c r i p t Information Classification: General authors explore the potential, prospects, and challenges of DTx in the management of Diabetes Mellitus.

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“…BT‐001 is a digital therapeutic application (app) providing CBT via smartphone supporting dietary change, physical activity, and medication adherence. An earlier version of the app, when paired with health coaching, was associated with a 1.1% fall in HbA1c after 3 months in a sample of 69 adults with T2D 7 ; in a separate pilot study ( n = 74), fasting blood glucose fell by 23 mg/dl after about 3 months 8 . Herein, we describe the design of a randomized, controlled trial assessing the efficacy and safety of this digital therapeutic app that delivers CBT with the intent to improve glycemic control in adults with T2D.…”

Section: Introductionmentioning

confidence: 98%

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

Canonico

Hsia

Guthrie³

et al. 2022

Clinical Cardiology

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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.

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Change in Glycemic Control With Use of a Digital Therapeutic in Adults With Type 2 Diabetes: Cohort Study

Cited by 6 publications

References 27 publications

Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference‐in‐differences analysis

Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference‐in‐differences analysis

Changing face of healthcare: digital therapeutics in the management of diabetes

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

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