The results will contribute to improved real-world hypoglycemia risk estimation and potentially safer, more effective clinical diabetes management. Analyses of sample characteristics, quality metrics, and hypoglycemia incidence and prognostication are currently underway with published results anticipated by fall 2022.Ĭonclusions: iNPHORM is the first hypoglycemia prognostic study in the United States to leverage prospective, longitudinal self-reports. Most follow-up waves (10,470/14,472, 72.35%) were completed, translating to a participation rate of 179% relative to our target sample size. A total of 1694 participants completed the baseline questionnaire, of whom 1206 (71.19%) were followed up for 12 months. Results: Recruitment and data collection occurred between February 2020 and March 2021 (ethics approval was obtained on December 17, 2019). The causal effects of different antihyperglycemics on hypoglycemia rates will also be investigated. Participant responses will be analyzed using multivariable count regression and machine learning techniques to develop and internally validate prognostic models for 1-year severe and 30-day nonsevere daytime and nocturnal hypoglycemia. Prospective data on hypoglycemia and potential prognostic factors were self-assessed across 14 closed, fully automated questionnaires (screening, baseline, and 12 monthly follow-ups) that were piloted using semistructured interviews (n=3) before fielding no face-to-face contact was required as part of the data collection. A sample size of 521 baseline responders was calculated for this study. Americans (aged 18-90 years) with self-reported type 1 or 2 diabetes mellitus prescribed insulin and/or secretagogues were conveniently sampled via the web from a pre-existing, closed, probability-based internet panel (sample frame). Methods: iNPHORM is a prospective, 12-wave internet-based panel survey that was conducted across the United States. As a secondary objective, iNPHORM aims to quantify the effects of different antihyperglycemics on hypoglycemia rates. Objective: This protocol describes the design and implementation of the 1-year iNPHORM (Investigating Novel Predictions of Hypoglycemia Occurrence Using Real-world Models) study, which aims to measure real-world self-reported severe and nonsevere hypoglycemia incidence (daytime and nocturnal) in American adults with type 1 or 2 diabetes mellitus prescribed insulin and/or secretagogues, and develop and internally validate prognostic models for severe, nonsevere daytime, and nonsevere nocturnal hypoglycemia. Schulich School of Medicine and Dentistryīackground: Hypoglycemia prognostic models contingent on prospective, self-reported survey data offer a powerful avenue for determining real-world event susceptibility and interventional targets. JMIR Bioinformatics and Biotechnology 16 articlesĭepartment of Epidemiology and Biostatistics. JMIR Biomedical Engineering 59 articles.JMIR Perioperative Medicine 65 articles.Journal of Participatory Medicine 69 articles.JMIR Rehabilitation and Assistive Technologies 168 articles.JMIR Pediatrics and Parenting 224 articles.Interactive Journal of Medical Research 244 articles.JMIR Public Health and Surveillance 940 articles.Journal of Medical Internet Research 6775 articles.
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