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

backgroundAn 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/

designA 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.