Significant research has been completed over the past several decades demonstrating the usefulness and benefits of the Digital BioScan+ and the tests completed during patient assessments. The table below describes the clinical validation including sensitivity and specificity for each of the test completed by the Digital BioScan+.
The links below provide several clinical studies and peer reviews completed by medical schools, researchers and many respected clinicians in the areas of autonomic nervous system and cardiovascular dysfunction.
Cardiac & Vascular
1. American Diabetes Association and American Academy of Neurology. Consensus statement: report and recommendations of the San Antonio Conferenceon Diabetic Neuropathy. Diabetes Care 1988; 11: 592–597.
2. Tesfaye S, Boulton AJ, Dyck PJ, et al.Diabetic neuropathies: update on deﬁnitions,diagnostic criteria, estimation of severity, and treatments. Diabetes Care 2010; 33: 2285–2293.
3. Ziegler D, Gries FA, Muhlen H, et al.Prevalence and clinical correlates of cardiovascularautonomic and peripheral diabetic neuropathy in patients attending diabetes centers. Diabetes Metab 1993; 19: 143–151.
4. Valensi P, Paries J, Attali JR; French Group for Research and Study of Diabetic Neuropathy. Cardiac autonomic neuropathy in diabetic patients:inﬂuence of diabetes duration, obesity, and microangiopathic complications– the French multicenter study.Metabolism 2003; 52: 815–820.
5. Low PA, Benrud-Larson LM, Sletten DM, et al. Autonomic symptoms and diabetic neuropathy: a population-based study.Diabetes Care 2004; 27: 2942–2947.
6. Pop-Busui R, Low PA, Waberski BH,et al. Effects of prior intensive insulintherapy on cardiac autonomic nervous system function in type 1 diabetes mellitus: the Diabetes Control and Complications.Trial/Epidemiology of Diabetes.Interventions and Complications study (DCCT/EDIC). Circulation 2009; 119: 2886–2893.
7. Ewing DJ, Martyn CN, Young RJ,Clarke BF. The value of cardiovascular autonomic function tests: 10 years experience in diabetes. Diabetes Care 1985; 8: 491–498.
8. Kempler P, Tesfaye S, Chaturvedi N, et al. Blood pressure response to standing in the diagnosis of autonomic neuropathy: the EURODIAB IDDM Complications Study. Arch Physiol Biochem 2001; 109: 215–222.
9. Maser RE, Mitchell BD, Vinik AI, Freeman R. The association between cardiovascular autonomic neuropathy and mortality in individuals with diabetes: a meta-analysis. Diabetes Care 2003; 26:1895–1901.
10. Wheeler SG, Ahroni JH, Boyko EJ. Prospective study of autonomic neuropathy as a predictor of mortality inpatients with diabetes. Diabetes Res Clin Pract 2002; 58: 131–138.
11. Astrup AS, Tarnow L, Rossing P, Hansen BV, Hilsted J, Parving HH. Cardiac autonomic neuropathy predicts cardiovascularmorbidity and mortality intype 1 diabetic patients with diabetic nephropathy. Diabetes Care 2006; 29: 334–339.
12. Wackers FJ, Young LH, Inzucchi SE, et al. Detection of silent myocardial ischemia in asymptomatic diabetic subjects: the DIAD study. Diabetes Care2004; 27: 1954–1961.
13. Valensi P, Sachs RN, Harfouche B, et al.Predictive value of cardiac autonomic neuropathy in diabetic patients with or without silent myocardial ischemia. DiabetesCare 2001; 24: 339–343.
14. Ryden L, Standl E, Bartnik M, et al.Guidelines on diabetes, pre-diabetes,and cardiovascular diseases: executivesummary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC)and of the European Association for theStudy of Diabetes (EASD). Eur Heart J.2007; 28: 88–136.
15. Millasseau SC et al. Determination of age-related increases in large artery stiﬀness by digital pulse contour analysis. Clinical Science (2002) 103, 371±377.
16. Takazawa, K et al. Assessment of Vasoactive Agents and Vascular Aging by the Second Derivative of Photoplethysmogram Waveform. Hypertension: Volume 32(2) August 1998pp 365-370
17. Bagherzadeh et al. Association of cardiac autonomic neuropathy with endothelial dysfunction in type 2 diabetes mellitus patients. Journal of Diabetes & Metabolic Disorders 2013, 12:55
18. Dimitropoulos G, Tahrani AA, Stevens MJ. Cardiac autonomic neuropathy in patients with diabetes mellitus. World J Diabetes 2014 February 15; 5(1): 17-39.
19. Spallone V.et al.. Cardiovascular autonomic neuropathy in diabetes: clinical impact, assessment, diagnosis, and management .Diabetes Metab Res Rev 2011; 27: 639–653.
20. Jae-Seung Yun et al. Cardiovascular Autonomic Dysfunction Predicts Severe Hypoglycemia in Patients With Type 2 Diabetes: A 10-Year Follow-up Study. Diabetes Care Volume 37, January 2014
21. ACCORD study publication. NIH news
22. Ben M.W. Illigens, Christopher H. Gibbons. Sweat testing to evaluate autonomic function Clin Auton. Res. 2009 April; 19(2): 79–87.
23. Aboyans V. et al. Measurement and Interpretation of the Ankle-Brachial Index: A Scientific Statement from the American Heart Association. Circulation, November 2012.