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.
Keywords: detection; diagnosis; diagnostic; digestion; digestive disease; digital health; evaluation; gastrointestinal; lactose intolerance; medical device; performance; testing.
©Simon C Mathews, Sandy Templeton, Stephanie K Taylor, Sten Harris, Margaret Stewart, Shruti M Raja. Originally published in JMIR Formative Research (https://formative.jmir.org), 18.10.2021.