Key result
A pocket-size device for detecting diabetic autonomic neuropathy demonstrated high correlation with standard spectral analysis equipment for measuring the 30:15 ratio (R2=0.98) and E:I ratio (R2=0.81).
Why the study?
Does a pocket-size device accurately measure heart rate variability parameters compared to standard equipment in healthy individuals and patients with diabetic autonomic neuropathy?
Cross-Sectional (n=18)
Does a pocket-size device accurately measure heart rate variability parameters compared to standard equipment in healthy individuals and patients with diabetic autonomic neuropathy?
Effect estimate: R2 = 0.98 for 30:15 ratio and R2 = 0.81 for E:I; 95% limits of agreement +/-0.014 and +/-0.033 respectively
A prototype pocket-size device demonstrated high correlation and agreement with standard spectral analysis equipment for measuring heart rate variability, suggesting its utility for ambulatory screening of diabetic autonomic neuropathy.
May support ambulatory screening for diabetic autonomic neuropathy; leaves open prospective validation of clinical utility.
BACKGROUND: Diabetic autonomic neuropathy (DAN) is a very frequent complication in the diabetic population (type 1 and type 2 diabetes), and patients may suffer debilitating symptoms from various organ systems. In the less symptomatic and even in the asymptomatic condition it severely impacts health. Testing for DAN is currently time-consuming and costly due to the technical setups available today, therefore the examination may not be offered regularly. The purpose of this study was to evaluate the clinical performance of a pocket-size device for detecting DAN by measuring heart rate variability (HRV). METHOD: Ten healthy young males and eight type 1 diabetes patients suffering symptomatic DAN were selected. The standardized spectral analysis equipment VariaPulse TF3 (Sima Media, Olumouc, Czechoslovakia) was used as a reference method for evaluating a prototype of the pocket-size device according to a specified protocol. HRV, inhalation/exhalation ratio (E:I) (deep breathing test), and 30:15 ratio (response going from lying to standing) were measured using both methods. Statistical calculations were performed. RESULTS: The correlation between the two devices was R(2) = 0.98 and R(2) = 0.81 when 30:15 ratio and E:I were measured, respectively. Bland-Altman plots showed suitable agreement between the two devices, substantiated by 95% limits of agreement of the differences of +/-0.014 and +/-0.033 when 30:15 ratio and E:I were measured, respectively. CONCLUSIONS: The pocket-size device was fully interchangeable with the hitherto-used, research-based setup. It proved highly suitable for ambulatory testing of autonomic nervous function and may facilitate screening for DAN according to Danish and international recommendations.
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Ejskjær et al. (2008) conducted a cross-sectional in Diabetic autonomic neuropathy (n=18). Pocket-size device for detecting DAN vs. Standardized spectral analysis equipment VariaPulse TF3 was evaluated on Heart rate variability (HRV), inhalation/exhalation ratio (E:I), and 30:15 ratio (R2 = 0.98 for 30:15 ratio and R2 = 0.81 for E:I; 95% limits of agreement +/-0.014 and +/-0.033 respectively). A pocket-size device for detecting diabetic autonomic neuropathy demonstrated high correlation with standard spectral analysis equipment for measuring the 30:15 ratio (R2=0.98) and E:I ratio (R2=0.81).
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