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.
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 diabetespatients 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.
Authors: M Charles; J Fleischer; D R Witte; N Ejskjaer; K Borch-Johnsen; T Lauritzen; A Sandbaek Journal: Diabetologia Date: 2012-10-12 Impact factor: 10.122
Authors: Jesper Fleischer; Knud Yderstraede; Elisabeth Gulichsen; Poul Erik Jakobsen; Hans Henrik Lervang; Ebbe Eldrup; Hans Nygaard; Lise Tarnow; Niels Ejskjaer Journal: J Diabetes Sci Technol Date: 2014-03-31
Authors: Tina Okdahl; Davide Bertoli; Birgitte Brock; Klaus Krogh; Filip Krag Knop; Christina Brock; Asbjørn M Drewes Journal: BMJ Open Date: 2021-01-06 Impact factor: 2.692