TY  - JOUR
AU  - Mathews, Simon C
AU  - Templeton, Sandy
AU  - Taylor, Stephanie K
AU  - Harris, Sten
AU  - Stewart, Margaret
AU  - Raja, Shruti M
PY  - 2021
DA  - 2021/10/18
TI  - Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study
JO  - JMIR Form Res
SP  - e33009
VL  - 5
IS  - 10
KW  - digital health
KW  - lactose intolerance
KW  - digestive disease
KW  - evaluation
KW  - medical device
KW  - detection
KW  - diagnostic
KW  - digestion
KW  - testing
KW  - performance
KW  - gastrointestinal
KW  - diagnosis
AB  - 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 
SN  - 2561-326X
UR  - https://formative.jmir.org/2021/10/e33009
UR  - https://doi.org/10.2196/33009
UR  - http://www.ncbi.nlm.nih.gov/pubmed/34544034
DO  - 10.2196/33009
ID  - info:doi/10.2196/33009
ER  -