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- Klonoff, D. C., et al.
(author)
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A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings
- 2022
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In: Journal of Diabetes Science and Technology. - : SAGE Publications. - 1932-2968.
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Journal article (peer-reviewed)abstract
- Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low–glucose and low-glucose hypoglycemia; very high–glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.
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| 3. |
- Sperzel, J, et al.
(author)
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Automatic measurement of atrial pacing thresholds in dual-chamber pacemakers: Clinical experience with atrial capture management
- 2005
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In: Heart Rhythm. - : Elsevier BV. - 1547-5271. ; 2:11, s. 1203-1210
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Journal article (peer-reviewed)abstract
- BACKGROUND The Medtronic EnPulse (TM) pacemaker incorporates the new atrial capture management (ACM) algorithm to automatically measure atrial capture thresholds and subsequently manage atrial pacing outputs. OBJECTIVES The purpose of this study was to evaluate the clinical performance of ACM. METHODS Two hundred patients with an indication for a dual-chamber pacemaker underwent implantation. ACM thresholds and manually measured atrial pacing thresholds were assessed at follow-up visits. Clinical equivalence was defined as the ACM-measured threshold being within -0.25 V to +0.5 V of the manually measured threshold. The clinician analyzed all ACM measurements performed in-office for evidence of proarrhythmia. RESULTS All 200 implanted patients had a 1-month visit, and validated manual and in-office ACM threshold data were available for 123 patients. The ACM threshold was 0.595 +/- 0.252 V, and the manual threshold was 0.584 +/- 0.233 V. The mean difference was 0.010 V with a 95% confidence interval of (-0.001, 0.021). The mean difference over all visits was 0.011 V. For all patients, the individual threshold differences were within the range of clinical equivalence at all visits. No atrial arrhythmias were observed during 892 ACM tests in 193 patients. CONCLUSION This study demonstrated that the ACM algorithm is safe, accurate, and reliable over time. ACM was demonstrated to be clinically equivalent to the manual atrial threshold test in all patients at 1 month and over the entire follow-up period of up to 6 months. ACM ensures atrial capture, may save time during follow-up, and can be used to manage atrial pacing outputs.
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