Telehealth and Meal Replacement Pilot Program for Improved Care of Underserved Patients With Diabetes

Introduction: Greater use of technology will allow patients with diabetes on insulin therapy to optimize their glucose levels, limit input from health care providers, and thus markedly reduce costs incurred by health care professional fees. A key component required to implement training in use of this technology is an intensive program of self-management which utilizes automated, cloud-based glucose data transfer and storage along with analysis and algorithm and endocrinologist based treatment recommendations. The hypothesis to be tested in this study is to demonstrate that inclusion of the technology based approach rather than standard of care will statistically significantly improve primary and secondary endpoints. A simple, technological approach is most suited to underserved populations where medical resources for patients with diabetes are scarce. A successful study will enhance the rationale for using Cloud-based meter and analysis systems.

Background: Diabetes mellitus is a very common disease with 22.3 million affected in the United states and with estimated annual costs of $245 billion(1). About 18 million people die every year from cardiovascular disease, for which diabetes and hypertension are major predisposing factors. The prevalence of diabetes in the USA is estimated to increase from 7.4% in 2014 to 12% in 2025. The increase is driven primarily by the increase in obesity .This is not exclusively a USA problem as globally the number of patients with diabetes will increase to 380 million from 246 million in 2007.(2) Much of this increase is attributable to the increase in obesity both globally and in the United States specifically (2) .

The American Diabetes Association recommends referral to an endocrinologist when patients do not achieve the desired goals of treatment, namely a HbA1C at or below 7.0% (3) However, in the standard care arm of the DCCT, the median Hb A1C documented during conventional treatment was 8.9% and only 12% of patients were at or below 7%.(ref).These data suggest that a large fraction of patients with diabetes should be referred to an endocrinologist for advice and/or management. However, workforce data report that only 15% % of patients with diabetes at present are evaluated by endocrinologists(4). Part of the reason is the gap in workforce numbers of Endocrinologists in the USA. There are the 5496 board certified adult endocrinologists in the USA currently(4) with an estimated gap of 1500 endocrinologists in 2014 .This gap which is estimated to grow to 2700 by 2025 unless more endocrinologists are trained. Diabetes. As diabetes care represents 46.1% of the coded visits of Endocrinologists(4) and there is a substantial workforce gap, it is obvious why involvement by endocrinologists is limited.

The data described above reveals that new approaches are needed to improve the care of patients with diabetes. This is perhaps more relevant for patients living in rural, undeserved areas where access to specialists, primary care teams focused on management of diabetes, and primary care providers is limited by professional, geographical and financial considerations(5) (ref) .

A proposed solution to the rural access problem is the use of telehealth and telemedicine. Telehealth is defined as access to providers and educational resources by video, smartphone, computer, telephone, cloud based glucose meters, text messaging and other means of rapid communication. Telemedicine specifically refers to patient encounters with providers via real time television interactions . These methodologies can alleviate the access problems due to geography, the availability of endocrinologists, and the cost of specific clinic visits. Pilot data from the Kaiser Permanente Health care system suggest that 90% of encounters with patients with diabetes can be replaced via telehealth methodology.