Evidence map›Paper›PMID 36181554›Full record

Trial reportDiabetes care2022

Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes.

Judith Hsia, Nicole L Guthrie, Paul Lupinacci, Ananda Gubbi, Douglas Denham, Mark A Berman, Marc P Bonaca

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  16. Download to heal: navigating the pixelated path of digital therapeutics in psychiatric care.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Judith HsiaCPC Clinical Research, Aurora, CO.ORCID 0000-0002-3413-7836
Nicole L GuthrieBetter Therapeutics, Inc., San Francisco, CA.
Paul LupinacciBetter Therapeutics, Inc., San Francisco, CA.
Ananda GubbiCPC Clinical Research, Aurora, CO.
Douglas DenhamClinical Trials of Texas, San Antonio, TX.
Mark A BermanBetter Therapeutics, Inc., San Francisco, CA.
Marc P BonacaCPC Clinical Research, Aurora, CO.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of a digital therapeutic application (app) delivering cognitive behavioral therapy (CBT) designed to improve glycemic control in patients with type 2 diabetes. RESEARCH DESIGN AND

methodsAdults with type 2 diabetes and an HbA1c of 7 to <11% were randomly assigned to receive access to a digital therapeutic app delivering CBT (BT-001) or a control app, both on top of standard of care management. CBT is an established form of psychological treatment that endeavors to identify and change unhelpful thinking patterns. The primary study end point was treatment group difference in mean HbA1c change from baseline to 90 days.

resultsAmong 669 randomly assigned subjects who completed app onboarding, the mean age was 58 years, BMI 35 kg/m2, 54% were female, 28% Black, and 16% Latino. Baseline HbA1c was 8.2 and 8.1% in the BT-001 and control groups, respectively. After 90 days of app access, change in HbA1c was -0.28% (95% CI -0.41, -0.15) in the BT-001 group and +0.11% (95% CI -0.02, 0.23) in the control group (treatment group difference 0.39%; P < 0.0001). HbA1c reduction paralleled exposure to the therapeutic intervention, assessed as the number of modules completed on the app (P for trend <0.0001). No adverse events in either group were attributed to app use and no adverse device effects reported.

conclusionsPatients randomly assigned to the BT-001 arm relative to the control arm had significantly lower HbA1c at 90 days. The digital therapeutic may provide a scalable treatment option for patients with type 2 diabetes.

Indexed as

Cognitive Behavioral TherapyDiabetes Mellitus, Type 2AdultFemaleGlycated HemoglobinGlycemic ControlHumansMaleMiddle AgedTreatment OutcomeGlycated Hemoglobin

Identifiers

PMID36181554
PMCPMC9862458

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.