@Article{info:doi/10.2196/33009,
author="Mathews, Simon C
and Templeton, Sandy
and Taylor, Stephanie K
and Harris, Sten
and Stewart, Margaret
and Raja, Shruti M",
title="Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study",
journal="JMIR Form Res",
year="2021",
month="Oct",
day="18",
volume="5",
number="10",
pages="e33009",
keywords="digital health; lactose intolerance; digestive disease; evaluation; medical device; detection; diagnostic; digestion; testing; performance; gastrointestinal; diagnosis",
abstract="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 ",
issn="2561-326X",
doi="10.2196/33009",
url="https://formative.jmir.org/2021/10/e33009",
url="https://doi.org/10.2196/33009",
url="http://www.ncbi.nlm.nih.gov/pubmed/34544034"
}