The Advantages of Using a Two-Arm Crossover Study Design to Establish Proof of Concept of Technology Interventions: The Case of a Mobile Web-Based Reporting of Glucose Readings in the Management of Gestational Diabetes Mellitus (GDM)

  • Nilmini Wickramasinghe
  • Steve Goldberg
Part of the Healthcare Delivery in the Information Age book series (Healthcare Delivery Inform. Age)


This chapter serves to illustrate the benefits of using a two-arm crossover study design to test the usability and fidelity issues and establish proof of concept for an innovative technology solution for a clinical context. Specifically, a pilot study is conducted to identify the potential benefits of utilising mobile web-based reporting of glucose readings in the management of gestational diabetes mellitus (GDM). Such an approach is suggested to be suitable to trial technology solutions in healthcare contexts.


Gestational diabetes Mobile health Smart phone health applications Chronic disease management 


  1. AIHW. (2007). National indicators for monitoring diabetes. In Report of the diabetes indicators review subcommittee of the national diabetes data working group: AIHW cat. No. CVD 38. Canberra, ACT: AIHW.Google Scholar
  2. AIHW. (2008). Diabetes: Australian facts 2008. Canberra, ACT: Australian Institute of Health and Welfare.Google Scholar
  3. Boyatzis, R. E. (1998). Transforming qualitative information: Thematic analysis and code development. Thousand Oaks, CA: Sage.Google Scholar
  4. Britt, H., Miller, G. C., Charles, J., Pan, Y., Valenti, L., Henderson, J., et al. (2007). General practice activity in Australia 2005–06, Cat. No. GEP 16. Canberra, ACT: AIHW.Google Scholar
  5. Business Insider Australia. (2013). “Chart: Global mobile phone penetration nears 100 percent. Retrieved July 30, 2013, from
  6. Campbell, D., & Stanely, J. (1963). Experimental and quasi-experimental designs for research. Boston: Houghton Mifflin Company.Google Scholar
  7. Carolan, M. (2013). Women’s experience of gestational diabetes self management: A qualitative study. Midwifery, 29, 637–645.CrossRefPubMedGoogle Scholar
  8. Devsam, B. U., Bogossian, E., & Peacock, A. S. (2013). An interpretative review of women’s experiences of gestational diabetes mellitus, proposing a framework to enhance midwifery assessment. Women and Birth, 26, 69–76.CrossRefGoogle Scholar
  9. Diabetes Australia. (2012). Gestational diabetes, Canberra, ACT: Diabetes Australia. Retrieved April 29, 2013, from
  10. Geisler, E., & Wickramasinghe, N. (2009). The role and use of wireless technology in the management and monitoring of chronic diseases. Washington, DC: IBM Center for The Business of Government.Google Scholar
  11. Getahun, D., Nath, C., Ananth, C. V., et al. (2008). Gestational diabetes in the United States: Temporal trends 1989 through 2004. American Journal Obstetrics Gynecology, 198, 525.e1–525.e5.CrossRefGoogle Scholar
  12. Goldberg, S. (2002a). Building the evidence for a standardized mobile internet (wireless) environment in Ontario, Canada. January Update. Internal INET documentation. North York, ON: INET.Google Scholar
  13. Goldberg, S. (2002b). HTA presentational selection and aggregation component summary. Internal INET documentation. North York, ON: INET.Google Scholar
  14. Goldberg, S. (2002c). Wireless POC device component summary. Internal INET documentation. North York, ON: INET.Google Scholar
  15. Goldberg, S. (2002d). HTA presentation rendering component summary. Internal INET documentation. North York, ON: INET.Google Scholar
  16. Goldberg, S. (2002e). HTA quality assurance component summary. Internal INET documentation. North York, ON: INET.Google Scholar
  17. Hedtke, P. (2008). Can wireless technology enable new diabetes management tools? Journal of Diabetes Science and Technology, 2(1), 127–130.CrossRefPubMedPubMedCentralGoogle Scholar
  18. Hills, M., & Armitage, P. (1979). The two-period cross-over clinical trial. British Journal of Clinical Pharmacology, 58(7), 7–20.CrossRefGoogle Scholar
  19. Hoffman, L., Nolan, C., Wilson, J. D., Oats, J., & Simmons, D. (1998). Gestational diabetes mellitus-management guidelines. Medical Journal of Australia, 169, 93–97.PubMedPubMedCentralGoogle Scholar
  20. IDF Diabetes Atlas. (2012). 5th edition–2012 update, International Diabetes Federation. Retrieved July 05, 2013, from
  21. Inet International Inc. (2013). Retrieved July 30, 2013, from
  22. Kvale, S. (1996). InterViews: An introduction to qualitative research interviewing. London: Sage.Google Scholar
  23. Le Rouge, C., & Wickramasinghe, N. (2013). A review of user-centered design for diabetes-related consumer health informatics technologies. Journal of Diabetes Science and Technology, 7(4), 1039–1056.CrossRefGoogle Scholar
  24. Chen, L., Magliano, D. J., & Zimmet, P. Z. (2012). The worldwide epidemiology of type 2 diabetes mellitus–present and future perspectives. Nature Reviews Endocrinology, 8(4), 228–236.CrossRefGoogle Scholar
  25. Rigby, A. (2003). Cross-over trials in clinical research. Journal of the Royal Statistical Society, 52(3), 417–418.Google Scholar
  26. Senn, S. (2002). Cross-over trials in clinical research (2nd ed.). New York: Wiley.CrossRefGoogle Scholar
  27. Siri, L., & Thomas, A. (1999). Gestational diabetes mellitus. New England Journal of Medicine, 341, 1749–1756.CrossRefGoogle Scholar
  28. Stratton, I. M., et al. (2000). Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes ‘(UKPDS 35): Prospective observational study’. BMJ, 321, 405–412.CrossRefPubMedPubMedCentralGoogle Scholar
  29. Victorian Government. (2007). Diabetes prevention and management: A strategic framework for Victoria 1007–2010. Melbourne, VIC: Victorian Government, Department of Human Services.Google Scholar
  30. Wickramasinghe, N., & Goldberg, S. (2004). How M=EC2 in healthcare. International Journal of Mobile Communications, 2(2), 140–156.CrossRefGoogle Scholar
  31. Wickramasinghe, N., & Goldberg, S. (2007). Adaptive mapping to realisation methodology (AMR) to facilitate mobile initiatives in healthcare. International Journal of Mobile Communications, 5(3), 300–318.CrossRefGoogle Scholar
  32. Wickramasinghe, N., Troshani, I., & Goldberg, S. (2010). An investigation into the use of pervasive wireless technologies to support diabetes healthcare. In A. Coronato & G. De Pietro (Eds.), Pervasive and smart technologies for healthcare: Ubiquitous methodologies and tools (Vol. 114–129). New York: IGI Global.Google Scholar
  33. Wickramasinghe, N., & Schaffer, J. (2010). Realizing value driven patient centric healthcare through technology. Washington, DC: IBM Center for The Business of Government.Google Scholar
  34. Wickramasinghe, N, Bali, R., Troshani, I., & Goldberg, S.. (2012). Pervasive knowledge management for healthcare. New York: Springer.Google Scholar
  35. Wickramasinghe, N., & Geisler, E. (Eds.). (2008). Encyclopedia of healthcare information systems. Hershey, PA: IGI Global.Google Scholar
  36. Wild, S., Roglic, G., Green, A., Sicree, R., & King, H. (2004). Global prevalence of diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care, 27(10), 1047–1053.CrossRefPubMedGoogle Scholar
  37. Windrum, P. (2008). Innovation in public sector services entrepreneurship, creativity and management. New York: Edward Elgar.CrossRefGoogle Scholar
  38. Winter, A. F., et al. (2001). Strategic information management plans: The basis for systematic information management in hospitals. International Journal of Medical Informatics, 64(2–3), 99–109.CrossRefPubMedGoogle Scholar
  39. World Health Organisation. (2013). “Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus. Retrieved July 31, 2013, from
  40. Yin, R. (1994). Case study research. Thousand Oaks, CA: Sage.Google Scholar
  41. Zimmet, P. (2000). 21st century review: Globalization, coca-colonization, and the chronic disease epidemic: Can the doomsday scenario be averted? Journal of Internal Medicine, 247(3), 301–310.CrossRefPubMedGoogle Scholar
  42. Zuvekas, S., & Cohen, J. (2007). Prescription drugs and the changing concentration of healthcare expenditures. Health Affairs, 26(1), 249–257.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Nilmini Wickramasinghe
    • 1
  • Steve Goldberg
    • 2
  1. 1.Deakin UniversityBurwoodAustralia
  2. 2.Inet International Inc.ThornhillCanada

Personalised recommendations