RESUMO
BACKGROUND: Hypoglycemia prognostic models contingent on prospective, self-reported survey data offer a powerful avenue for determining real-world event susceptibility and interventional targets. 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. As a secondary objective, iNPHORM aims to quantify the effects of different antihyperglycemics on hypoglycemia rates. METHODS: iNPHORM is a prospective, 12-wave internet-based panel survey that was conducted across the United States. 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). A sample size of 521 baseline responders was calculated for this study. 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. 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. The causal effects of different antihyperglycemics on hypoglycemia rates will also be investigated. RESULTS: Recruitment and data collection occurred between February 2020 and March 2021 (ethics approval was obtained on December 17, 2019). A total of 1694 participants completed the baseline questionnaire, of whom 1206 (71.19%) were followed up for 12 months. 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. Over 70.98% (856/1206) completed wave 12. Analyses of sample characteristics, quality metrics, and hypoglycemia incidence and prognostication are currently underway with published results anticipated by fall 2022. CONCLUSIONS: iNPHORM is the first hypoglycemia prognostic study in the United States to leverage prospective, longitudinal self-reports. The results will contribute to improved real-world hypoglycemia risk estimation and potentially safer, more effective clinical diabetes management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04219514; https://clinicaltrials.gov/ct2/show/NCT04219514. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33726.
RESUMO
MAIN OBJECTIVE: To determine how and to what extent COVID-19 has affected real-world, self-reported glycaemic management in Americans with type 1 or type 2 diabetes taking insulin and/or secretagogues, with or without infection. DESIGN: A cross-sectional substudy using data from the Investigating Novel Predictions of Hypoglycemia Occurrence using Real-world Models panel survey. SETTING: USA. PARTICIPANTS: Americans 18-90 years old with type 1 or 2 diabetes taking insulin and/or secretagogues were conveniently sampled from a probability-based internet panel. PRIMARY OUTCOME MEASURE: A structured, COVID-19-specific questionnaire was administered to assess the impact of the pandemic (irrespective of infection) on socioeconomic, behavioural/clinical and psychosocial aspects of glycaemic management. RESULTS: Data from 667 respondents (type 1 diabetes: 18%; type 2 diabetes: 82%) were analysed. Almost 25% reported A1c values ≥8.1%. Rates of severe and non-severe hypoglycaemia were 0.68 (95% CI 0.5 to 0.96) and 2.75 (95% CI 2.4 to 3.1) events per person-month, respectively. Ten respondents reported a confirmed or probable COVID-19 diagnosis. Because of the pandemic, 24% of respondents experienced difficulties affording housing; 28% struggled to maintain sufficient food to avoid hypoglycaemia; and 19% and 17% reported challenges accessing diabetes therapies and testing strips, respectively. Over one-quarter reported issues retrieving antihyperglycaemics from the pharmacy and over one-third reported challenges consulting with diabetes providers. The pandemic contributed to therapeutic non-adherence (14%), drug rationing (17%) and reduced monitoring (16%). Many struggled to keep track, and in control, of hypoglycaemia (12%-15%) and lacked social support to help manage their risk (19%). Nearly half reported decreased physical activity. Few statistically significant differences were observed by diabetes type. CONCLUSIONS: COVID-19 was found to cause substantial self-reported deficiencies in glycaemic management. Study results signal the need for decisive action to restabilise routine diabetes care in the USA. TRIAL REGISTRATION NUMBER: NCT04219514.