%0 Journal Article
%@ 2561-326X
%I JMIR Publications
%V 5
%N 10
%P e33009
%T Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study
%A Mathews,Simon C
%A Templeton,Sandy
%A Taylor,Stephanie K
%A Harris,Sten
%A Stewart,Margaret
%A Raja,Shruti M
%+ Johns Hopkins Medicine, 1800 Orleans St, Baltimore, MD, 21287, United States, 1 410 955 5000, smathe14@jhmi.edu
%K digital health
%K lactose intolerance
%K digestive disease
%K evaluation
%K medical device
%K detection
%K diagnostic
%K digestion
%K testing
%K performance
%K gastrointestinal
%K diagnosis
%D 2021
%7 18.10.2021
%9 Original Paper
%J JMIR Form Res
%G English
%X Background: Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-based equipment and conduction of the testing in a clinical setting. Objective: The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)–cleared device (H2 Check) for the same indication. Methods: An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance. Results: A total of 31 participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinal symptoms and hydrogen values was positive at 0.82 (P<.001). Conclusions: The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleared device in the diagnosis of lactose malabsorption. Trial Registration: ClinicalTrials.gov NCT04754724; https://clinicaltrials.gov/ct2/show/NCT04754724 
%M 34544034
%R 10.2196/33009
%U https://formative.jmir.org/2021/10/e33009
%U https://doi.org/10.2196/33009
%U http://www.ncbi.nlm.nih.gov/pubmed/34544034