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Within-Person and Between-Sensor Variability in Continuous Glucose Monitoring Metrics
Selvin, Elizabeth; Wang, Dan; Rooney, Mary R; Fang, Michael; Echouffo-Tcheugui, Justin B; Zeger, Scott; Sartini, Joseph; Tang, Olive; Coresh, Josef; Aurora, R Nisha; Punjabi, Naresh M
BACKGROUND:The within-person and between-sensor variability of metrics from different interstitial continuous glucose monitoring (CGM) sensors in adults with type 2 diabetes not taking insulin is unclear. METHODS:Secondary analysis of data from 172 participants from the Hyperglycemic Profiles in Obstructive Sleep Apnea randomized clinical trial. Participants simultaneously wore Dexcom G4 and Abbott Libre Pro CGM sensors for up to 2 weeks at baseline and again at the 3-month follow-up visit. RESULTS:At baseline (up to 2 weeks of CGM), mean glucose for both the Abbott and Dexcom sensors was approximately 150 mg/dL (8.3 mmol/L) and time in range (70-180 mg/dL [3.9-10.0 mmol/L]) was just below 80%. When comparing the same sensor at 2 different time points (two 2-week periods, 3 months apart), the within-person coefficient of variation (CVw) in mean glucose was 17.4% (Abbott) and 14.2% (Dexcom). CVw for percent time in range: 20.1% (Abbott) and 18.6% (Dexcom). At baseline, the Pearson correlation of mean glucose from the 2 sensors worn simultaneously was r = 0.86, root mean squared error (RMSE), 13 mg/dL (0.7 mmol/L); for time in range, r = 0.88, RMSE, 8 percentage points. CONCLUSIONS:Substantial variation was observed within sensors over time and across 2 different sensors worn simultaneously on the same individuals. Clinicians should be aware of this variability when using CGM technology to make clinical decisions. ClinicalTrials.gov Identifier: NCT02454153.
PMID: 36495162
ISSN: 1530-8561
CID: 5404942
The Associations of Mean Glucose and Time in Range from Continuous Glucose Monitoring with HbA1c in Adults with Type 2 Diabetes
Selvin, Elizabeth; Wang, Dan; Rooney, Mary R; Echouffo-Tcheugui, Justin; Fang, Michael; Zeger, Scott; Sartini, Joseph; Tang, Olive; Coresh, Josef; Aurora, R Nisha; Punjabi, Naresh M
Associations of mean glucose and time in range (70-180 mg/dL) from continuous glucose monitoring (CGM) with HbA1c in adults with type 2 diabetes are not well characterized. We conducted a secondary analysis of 186 participants from the Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) trial. Participants simultaneously wore Dexcom G4 and Abbott Libre Pro CGM sensors up to 4 weeks. Mean HbA1c was 7.7% (SD, 1.3). There were strong negative Pearson's correlations of HbA1c with CGM time in range (-0.79, Abbott; -0.81, Dexcom) and strong positive correlations with CGM mean glucose (Dexcom, 0.84; Abbott, 0.82). However, there were large differences in CGM mean glucose (±20 mg/dL) and time in range (±14%) at any given HbA1c value. Mean glucose and HbA1c are strongly correlated in type 2 diabetes patients not taking insulin but discordance is evident at the individual level. Clinicians should expect discordance and use HbA1c and CGM in a complementary manner. ClinicalTrials.gov Identifier: NCT02454153.
PMCID:9810347
PMID: 36108310
ISSN: 1557-8593
CID: 5404932
Enhancing public health and safety by diagnosing and treating obstructive sleep apnea in the transportation industry: an American Academy of Sleep Medicine position statement
Das, Aneesa M; Chang, Judy L; Berneking, Michael; Hartenbaum, Natalie P; Rosekind, Mark; Ramar, Kannan; Malhotra, Raman K; Carden, Kelly A; Martin, Jennifer L; Abbasi-Feinberg, Fariha; Nisha Aurora, R; Kapur, Vishesh K; Olson, Eric J; Rosen, Carol L; Rowley, James A; Shelgikar, Anita V; Trotti, Lynn Marie; Gurubhagavatula, Indira
UNLABELLED:Obstructive sleep apnea (OSA) may lead to serious health, safety, and financial implications-including sleepiness-related crashes and incidents-in workers who perform safety-sensitive functions in the transportation industry. Evidence and expert consensus support its identification and treatment in high-risk commercial operators. An Advanced Notice of Proposed Rulemaking regarding the diagnosis and treatment of OSA in commercial truck and rail operators was issued by the Federal Motor Carrier Safety Administration and Federal Railroad Administration, but it was later withdrawn. This reversal has led to questions about whether efforts to identify and treat OSA are warranted. In the absence of clear directives, we urge key stakeholders, including clinicians and patients, to engage in a collaborative approach to address OSA by following, at a minimum, the 2016 guidelines issued by a Medical Review Board of the Federal Motor Carrier Safety Administration, alone or in combination with 2006 guidance by a joint task force. The current standard of care demands action to mitigate the serious health and safety risks of OSA. CITATION:2022;18(10):2467-2470.
PMCID:9516580
PMID: 34534065
ISSN: 1550-9397
CID: 5405172
Sex differences in Epworth Sleepiness Scale normalization with continuous positive airway pressure
Scharf, Matthew T; Zhang, Peng; Walker, Nathan A; Mirza, Mariam; Jobanputra, Aesha M; Aurora, R Nisha; Sunderram, Jag; Lu, Shou-En
STUDY OBJECTIVES:Continuous positive airway pressure (CPAP) improves sleepiness in patients with obstructive sleep apnea, but some patients remain sleepy. The objective of this study was to identify determinants that are associated with improvements in self-reported sleepiness in patients with obstructive sleep apnea on CPAP therapy. METHODS:A retrospective cohort study was performed in a clinic-based population to determine which variables contributed to the improvement in the Epworth Sleepiness Scale (ESS) in patients on CPAP therapy for OSA, stratified by baseline ESS score (< 11 or ≥ 11). Variables associated with ESS scores normalizing with CPAP were also assessed. RESULTS:Patients with a baseline high ESS score showed greater improvements in the ESS with CPAP. When looking at interactions between baseline ESS classification and changes in ESS, we found that a higher apnea-hypopnea index was only associated with improvement in the ESS among patients with a high baseline ESS. Other assessed factors or covariates were not significantly different. When looking at ESS normalization, we found that female sex and lower body mass index were associated with a lower likelihood of ESS normalization. The difference in the rate of ESS normalization between females and males was higher with more days on CPAP. CONCLUSIONS:Of all the assessed factors and covariates, only the apnea-hypopnea index was associated with the change in the ESS differently in patients with a high or normal baseline ESS score. ESS normalization rates were lower in females than in males, and this disparity was amplified by more days on CPAP. CITATION:2022;18(9):2273-2279.
PMCID:9435344
PMID: 35499278
ISSN: 1550-9397
CID: 5400792
Age and weight considerations for the use of continuous positive airway pressure therapy in pediatric populations: an American Academy of Sleep Medicine position statement
Amos, Louella; Afolabi-Brown, Olufunke; Gault, Dominic; Lloyd, Robin; Prero, Moshe Y; Rosen, Carol L; Malhotra, Raman K; Martin, Jennifer L; Ramar, Kannan; Rowley, James A; Abbasi-Feinberg, Fariha; Aurora, R Nisha; Kapur, Vishesh K; Kazmi, Uzma; Kuhlmann, David; Olson, Eric J; Shelgikar, Anita V; Thomas, Sherene M; Trotti, Lynn Marie
UNLABELLED:This position statement provides guidance for age and weight considerations for using continuous positive airway pressure therapy in pediatric populations. The American Academy of Sleep Medicine commissioned a task force of experts in pediatric sleep medicine to review the medical literature and develop a position statement based on a thorough review of these studies and their clinical expertise. The American Academy of Sleep Medicine Board of Directors approved the final position statement. It is the position of the American Academy of Sleep Medicine that continuous positive airway pressure can be safe and effective for the treatment of obstructive sleep apnea for pediatric patients, even in children of younger ages and lower weights, when managed by a clinician with expertise in evaluating and treating pediatric obstructive sleep apnea. The clinician must make the ultimate judgment regarding any specific care in light of the individual circumstances presented by the patient, accessible treatment options, patient/parental preference, and resources. CITATION:. 2022;18(8):2041-2043.
PMCID:9340596
PMID: 35638127
ISSN: 1550-9397
CID: 5400822
Glucose profiles in obstructive sleep apnea and type 2 diabetes mellitus
Aurora, R Nisha; Gaynanova, Irina; Patel, Pratik; Punjabi, Naresh M
OBJECTIVES:Continuous glucose monitoring (CGM) provides temporal data on glycemic variability, a predictor of outcomes related to type 2 diabetes mellitus. The current study sought to determine whether CGM-derived metrics in patients with type 2 diabetes are different in moderate-to-severe versus mild obstructive sleep apnea (OSA). METHODS:In adults with type 2 diabetes, home testing was used of assess the presence of OSA. CGM data were collected for at least 7 days in those with an oxygen desaturation index (ODI) ≥ 5 events/hr. The study sample was divided into mild (ODI: 5.0-14.9 events/hr) and moderate-to-severe OSA (ODI ≥15 events/hr). Actigraphy was used to distinguish the wake and sleep periods. CGM-derived metrics were compared between the two groups using multivariable regression models. RESULTS:Compared to mild OSA, patients with moderate-to-severe OSA had higher mean glucose levels during sleep (adjusted difference 8.4 mg/dL; p-value: 0.03) and wakefulness (adjusted difference 7.1 mg/dL; p-value: 0.06). Moderate-to-severe OSA patients also had lower odds for having their glucose values within the acceptable range during wakefulness than those with mild OSA (adjusted odds ratio of 0.63; p-value: 0.02). The mean amplitude of glycemic excursion and standard deviation of the rate of change in glucose values (SD-ROC) were higher in moderate-to-severe than mild OSA, but only during wakefulness. Sex modified the association between OSA severity and SD-ROC, but not the other CGM-derived metrics. CONCLUSIONS:In patients with type 2 diabetes, moderate-to-severe OSA is associated with greater abnormalities in CGM-derived metrics than mild OSA with notable differences between sleep and wakefulness.
PMID: 35569327
ISSN: 1878-5506
CID: 5400802
Methods for home-based self-applied polysomnography: the Multicenter AIDS Cohort Study
Punjabi, Naresh M; Brown, Todd; Aurora, R Nisha; Patel, Sanjay R; Stosor, Valentina; Cho, Joshua Hyong-Jin; Helgadóttir, Halla; Ágústsson, Jón Skírnir; D'Souza, Gypsyamber; Margolick, Joseph B
STUDY OBJECTIVES/UNASSIGNED:Along with multiple chronic comorbidities, sleep disorders are prevalent in people living with human immunodeficiency virus (HIV) infection. The goal of this study was to establish methods for assessing sleep quality and breathing-related disorders using self-applied home polysomnography in people with and without HIV. METHODS/UNASSIGNED:Self-applied polysomnography was conducted on 960 participants in the Multicenter AIDS Cohort Study (MACS) using the Nox A1 recorder to collect data on the frontal electroencephalogram (EEG), bilateral electrooculograms, and a frontalis electromyogram during sleep. Breathing patterns were characterized using respiratory inductance plethysmography bands and pulse oximetry. Continuous recordings of the electrocardiogram were also obtained. All studies were scored centrally for sleep stages and disordered breathing events. RESULTS/UNASSIGNED:= 851), signal quality was rated as good, very good, or excellent in 810 (95.2%). No temporal trends in study quality were noted. Independent correlates of an unsuccessful study included black race, current smoking, and cocaine use. CONCLUSIONS/UNASSIGNED:Home polysomnography was successfully completed in the MACS demonstrating its feasibility in a community cohort. Given the burden of in-lab polysomnography, the methods described herein provide a cost-effective alternative for collecting sleep data in the home.
PMCID:9119085
PMID: 35601080
ISSN: 2632-5012
CID: 5400812
Referral of adults with obstructive sleep apnea for surgical consultation: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment
Kent, David; Stanley, Jeffrey; Aurora, R Nisha; Levine, Corinna G; Gottlieb, Daniel J; Spann, Matthew D; Torre, Carlos A; Green, Katherine; Harrod, Christopher G
INTRODUCTION:This systematic review provides supporting evidence for the accompanying clinical practice guideline on the referral of adults with obstructive sleep apnea (OSA) for surgical consultation. METHODS:The American Academy of Sleep Medicine commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies that compared the use of upper airway sleep apnea surgery or bariatric surgery to no treatment as well as studies that reported on patient-important and physiologic outcomes pre- and postoperatively. Statistical analyses were performed to determine the clinical significance of using surgery to treat obstructive sleep apnea in adults. Finally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) process was used to assess the evidence for making recommendations. RESULTS:The literature search resulted in 274 studies that provided data suitable for statistical analyses. The analyses demonstrated that surgery as a rescue therapy results in a clinically significant reduction in excessive sleepiness, snoring, blood pressure (BP), apnea-hypopnea index (AHI), respiratory disturbance index (RDI), and oxygen desaturation index (ODI); an increase in lowest oxygen saturation (LSAT) and sleep quality; and an improvement in quality of life in adults with OSA who are intolerant or unaccepting of positive airway pressure (PAP) therapy. The analyses demonstrated that surgery as an adjunctive therapy results in a clinically significant reduction in optimal PAP pressure and improvement in PAP adherence in adults with OSA who are intolerant or unaccepting of PAP due to side effects associated with high pressure requirements. The analyses also demonstrated that surgery as an initial treatment results in a clinically significant reduction in AHI/RDI, sleepiness, snoring, BP, and ODI and an increase in LSAT in adults with OSA and major anatomical obstruction. Analysis of bariatric surgery data showed a clinically significant reduction in BP, AHI/RDI, sleepiness, snoring, optimal PAP level, BMI, and ODI and an increase in LSAT in adults with OSA and obesity. Analyses of very limited evidence suggested that upper airway surgery does not result in a clinically significant increase in risk of serious persistent adverse events and suggested that bariatric surgery may result in a clinically significant risk of iron malabsorption that may be managed with iron supplements. The task force provided a detailed summary of the evidence along with the quality of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations. CITATION:2021;17(12):2507-2531.
PMCID:8726364
PMID: 34351849
ISSN: 1550-9397
CID: 5404952
Referral of adults with obstructive sleep apnea for surgical consultation: an American Academy of Sleep Medicine clinical practice guideline
Kent, David; Stanley, Jeffrey; Aurora, R Nisha; Levine, Corinna; Gottlieb, Daniel J; Spann, Matthew D; Torre, Carlos A; Green, Katherine; Harrod, Christopher G
INTRODUCTION:This guideline establishes clinical practice recommendations for referring adults with obstructive sleep apnea (OSA) for surgical consultation. METHODS:The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine, otolaryngology, and bariatric surgery to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using the GRADE process. The task force evaluated the relevant literature and the quality of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations that support the recommendations. The AASM Board of Directors approved the final recommendations. RECOMMENDATIONS:, and persistent inadequate PAP adherence due to pressure-related side effects as part of a patient-oriented discussion of adjunctive or alternative treatment options (CONDITIONAL). (4) We suggest that clinicians recommend PAP as initial therapy for adults with OSA and a major upper airway anatomic abnormality prior to consideration of referral for upper airway surgery (CONDITIONAL). CITATION:2021;17(12):2499-2505.
PMCID:8726361
PMID: 34351848
ISSN: 1550-9397
CID: 5400772
Sleep is essential to health: an American Academy of Sleep Medicine position statement
Ramar, Kannan; Malhotra, Raman K; Carden, Kelly A; Martin, Jennifer L; Abbasi-Feinberg, Fariha; Aurora, R Nisha; Kapur, Vishesh K; Olson, Eric J; Rosen, Carol L; Rowley, James A; Shelgikar, Anita V; Trotti, Lynn Marie
CITATION:Sleep is a biological necessity, and insufficient sleep and untreated sleep disorders are detrimental for health, well-being, and public safety. Healthy People 2030 includes several sleep-related objectives with the goal to improve health, productivity, well-being, quality of life, and safety by helping people get enough sleep. In addition to adequate sleep duration, healthy sleep requires good quality, appropriate timing, regularity, and the absence of sleep disorders. It is the position of the American Academy of Sleep Medicine (AASM) that sleep is essential to health. There is a significant need for greater emphasis on sleep health in education, clinical practice, inpatient and long-term care, public health promotion, and the workplace. More sleep and circadian research is needed to further elucidate the importance of sleep for public health and the contributions of insufficient sleep to health disparities. CITATION:. 2021;17(10):2115-2119.
PMCID:8494094
PMID: 34170250
ISSN: 1550-9397
CID: 5400762