Journal Article
. 2014 Feb; 14:11.
doi: 10.1186/1472-6947-14-11.

Design of a randomized, non-inferiority trial to evaluate the reliability of videoconferencing for remote consultation of diabetes

Farhad Fatehi 1 Melinda Martin-Khan  Leonard C Gray  Anthony W Russell  
  • PMID: 24528569
  •     22 References
  •     4 citations


Background: An estimated 366 million people are living with diabetes worldwide and it is predicted that its prevalence will increase to 552 million by 2030. Management of this disease and its complications is a challenge for many countries. Optimal glycaemic control is necessary to minimize complications, but less than 70% of diabetic patients achieve target levels of blood glucose, partly due to poor access to qualified health care providers. Telemedicine has the potential to improve access to health care, especially for rural and remote residents. Video teleconsultation, a real-time (or synchronous) mode of telemedicine, is gaining more popularity around the world through recent improvements in digital telecommunications. If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management, then it is important to demonstrate that this can be achieved without loss of clinical fidelity. This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes.

Methods/Design: A total of 160 people with diabetes will be randomised into either a Telemedicine or a Reference group. Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference. The primary outcome measure will be a change in the patient's medication. Secondary outcome measures will be findings in physical examination, detecting complications, and patient satisfaction. A difference of less than 20% in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care (face-to-face).

Discussion: Despite rapid growth in application of telemedicine in a variety of medical specialties, little is known about the reliability of videoconferencing for remote consultation of people with diabetes. Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes.

Trial Registration Number: Australian New Zealand Clinical Trials Registry ACTRN12612000315819.

Video consultation for trauma and emergency surgical patients.
Bellal Joseph, George Hadeed, +2 authors, Ronald S Weinstein.
Crit Care Nurs Q, 2012 Sep 06; 35(4). PMID: 22948367
Metabolic control and morbidity of type 2 diabetic patients in a general practice network.
M Bouma, J H Dekker, +3 authors, R J Heine.
Fam Pract, 1999 Sep 24; 16(4). PMID: 10493712
A clinimetric study of outpatient diabetes consultations: the potential for telemedicine substitution.
Farhad Fatehi, Leonard C Gray, Anthony W Russell.
Diabetes Technol Ther, 2013 Oct 26; 16(1). PMID: 24156361
The diagnostic accuracy of telegeriatrics for the diagnosis of dementia via video conferencing.
Melinda Martin-Khan, Leon Flicker, +6 authors, Leonard C Gray.
J Am Med Dir Assoc, 2012 May 11; 13(5). PMID: 22572552
Teleradiology: evolution and concepts.
F H Barneveld Binkhuysen, E R Ranschaert.
Eur J Radiol, 2010 Sep 28; 78(2). PMID: 20869183
What do we really know about the cost-effectiveness of telemedicine?
S Håkansson, C Gavelin.
J Telemed Telecare, 2000 May 04; 6 Suppl 1. PMID: 10793998
IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030.
David R Whiting, Leonor Guariguata, Clara Weil, Jonathan Shaw.
Diabetes Res Clin Pract, 2011 Nov 15; 94(3). PMID: 22079683
Highly Cited.
Telemedicine can lower costs and improve access.
B L Charles.
Healthc Financ Manage, 2000 Aug 01; 54(4). PMID: 10915354
Asynchronous and synchronous teleconsultation for diabetes care: a systematic literature review.
Fenne Verhoeven, Karin Tanja-Dijkstra, +2 authors, Lisette van Gemert-Pijnen.
J Diabetes Sci Technol, 2010 Jun 02; 4(3). PMID: 20513335    Free PMC article.
Systematic Review.
Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement.
Gilda Piaggio, Diana R Elbourne, +3 authors, CONSORT Group.
JAMA, 2012 Dec 27; 308(24). PMID: 23268518
Highly Cited.
The measurement of observer agreement for categorical data.
J R Landis, G G Koch.
Biometrics, 1977 Mar 01; 33(1). PMID: 843571
Highly Cited.
Access to health care and control of ABCs of diabetes.
Xuanping Zhang, Kai McKeever Bullard, +5 authors, Giuseppina Imperatore.
Diabetes Care, 2012 Apr 24; 35(7). PMID: 22522664    Free PMC article.
Video-telemedicine in a memory disorders clinic: evaluation and management of rural elders with cognitive impairment.
Cynthia Barton, Rebecca Morris, Johannes Rothlind, Kristine Yaffe.
Telemed J E Health, 2011 Oct 26; 17(10). PMID: 22023458
The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.
Diabetes Control and Complications Trial Research Group, D M Nathan, +6 authors, C Siebert.
N Engl J Med, 1993 Sep 30; 329(14). PMID: 8366922
Highly Cited.
Assessment of the accuracy of low-cost store-and-forward teledermatology consultation.
W A High, M S Houston, +2 authors, M T McEvoy.
J Am Acad Dermatol, 2000 Apr 25; 42(5 Pt 1). PMID: 10775853
Interdisciplinary telecommunication and expert teleconsultation in diagnostic pathology: present status and future prospects.
Klaus Kayser.
J Telemed Telecare, 2003 Jan 23; 8(6). PMID: 12537919
Access to care and the incidence of end-stage renal disease due to diabetes.
Michael M Ward.
Diabetes Care, 2009 May 23; 32(6). PMID: 19460914    Free PMC article.
Telemedicine for clinical management of diabetes - a process analysis of video consultations.
Farhad Fatehi, Leonard C Gray, Anthony W Russell.
J Telemed Telecare, 2013 Nov 13; 19(7). PMID: 24218349
Standards of care of diabetic patients in a typical English community.
N R Dunn, P Bough.
Br J Gen Pract, 1996 Jul 01; 46(408). PMID: 8776910    Free PMC article.
Telemedicine and remote patient monitoring.
Marilyn J Field, Jim Grigsby.
JAMA, 2002 Jul 23; 288(4). PMID: 12132953
Global estimates of the prevalence of diabetes for 2010 and 2030.
J E Shaw, R A Sicree, P Z Zimmet.
Diabetes Res Clin Pract, 2009 Nov 10; 87(1). PMID: 19896746
Highly Cited.
A review of telemedicine interventions in diabetes care.
L S A Nishan Siriwardena, W A Sudarshana Wickramasinghe, +3 authors, Roshan Hewapathirana.
J Telemed Telecare, 2012 Mar 01; 18(3). PMID: 22362832
A survey of the breast care nurse role in the provision of information and supportive care to Australian women diagnosed with breast cancer.
Tracey Ahern, Anne Gardner, Mary Courtney.
Nurs Open, 2015 Jun 02; 2(2). PMID: 27708802    Free PMC article.
Research on Teleconsultation service quality based on multi-granularity linguistic information: the perspective of regional doctors.
Wei Lu, Xin-Pu Wang, Jie Zhao, Yun-Kai Zhai.
BMC Med Inform Decis Mak, 2020 Jun 20; 20(1). PMID: 32552734    Free PMC article.
Impact of Teleconsultation on Patients With Type 2 Diabetes in the Brazilian Public Health System: Protocol for a Randomized Controlled Trial (TELEconsulta Diabetes Trial).
Daniela Laranja Gomes Rodrigues, Gisele Silvestre Belber, +5 authors, Álvaro Avezum Júnior.
JMIR Res Protoc, 2021 Jan 22; 10(1). PMID: 33475516    Free PMC article.
Telephone Consultation in Otorhinolaryngology During the Coronavirus Disease 2019 Pandemic: a Cross-sectional Analysis of Effectiveness and Satisfaction for Patients and Clinicians.
Ramanathan Swaminathan, Zahir Mughal, David Phillips.
SN Compr Clin Med, 2022 Jan 18; 4(1). PMID: 35036851    Free PMC article.