The Diabetes TeleCare Study

According to recent 2002 estimates, the yearly cost of diabetes was approximately $132
billion. The burden of diabetes is considerable, particularly for ethnically diverse
populations. Disease management programs that focus on self-management education have been
effective in improving metabolic control. Accordingly, the American Diabetes Association
clinical care guidelines stress the importance of metabolic control to prevent complications
and improve quality of life for persons with this disease. Unfortunately, these advances have
not resulted in widespread acceptance into clinical practice. Therefore, we propose
translational research to evaluate telemedicine technology using interactive video
conferencing (Diabetes TeleCare) as a novel means to increase the availability of health
professionals in rural communities for the effective delivery of a diabetes self-management
education program and as a means to provide retinal screenings in the primary care setting.
Our aims are to 1) develop and implement a 12-month intervention, Diabetes TeleCare to
improve adherence to diabetes clinical care guidelines and improve diabetes control in two
community health centers located in ethnically diverse, rural and medically underserved
communities, 2) conduct a one-year randomized clinical trial (RCT) of 200 patients to
formally evaluate the effectiveness of Diabetes TeleCare compared to Usual Care in a sample
with >60% African-Americans, and 3) determine the cost-effectiveness and satisfaction of
Diabetes TeleCare compared to Usual Care. Participants are recruited from two community
health centers in rural South Carolina and randomized according to a patient randomization
schedule. Diabetes TeleCare (a structured curriculum) is delivered by a team consisting of a
registered nurse/certified diabetes educator (RN-CDE) and an experienced registered
dietitian, with support by other health professionals who are linked by interactive video
conferencing to participants (single and group) in rural health centers at distant locations.
The primary outcomes are measures of metabolic control (A1c, lipids), blood pressure, and use
of the telemedicine-facilitated retinal screening capacity. Secondary outcomes include
satisfaction, quality of life, health beliefs, and knowledge. The economic analysis will
include an assessment of resource utilization, cost, and health utilities. In addition,
incremental reductions in costs per A1c and the estimated lifetime cost-utility of Diabetes
TeleCare compared to usual care will be determined. Telemedicine may be an effective
alternative to traditional health care delivery systems resulting in improved diabetes
education and control.

The intervention goal was to achieve an A1c <7%, with secondary goals of 10% weight loss and
increasing exercise to at least 30 minutes a day, 5 days a week. Participants attend 13
sessions, 2 in the first month (1 group, 1 individual), monthly thereafter (9 group, 2
individual). Three group sessions were conducted in-person, all others were conducted via
telemedicine. The self-management education team consisted of an RN/CDE and an RD. Sessions
were conducted remotely, with a trained facilitator (LPN) at the clinic site. Participants
were given a notebook and new material was added at each session. Completion of
self-monitoring logs, including blood sugar, diet and physical activity, was assigned daily
followed by less frequently based on progress towards intervention goals.

Inclusion Criteria:

- All participants must have a confirmed physician diagnosis of type 2 diabetes
supported by American Diabetes Association diagnostic criteria for blood glucose
levels or

- Current use of oral hypoglycemic agents or insulin as confirmed by brief medical
record review.

- All adults (> 21 years of age) who have a A1c value > 7.0 will be eligible.

Exclusion Criteria:

- Exclusion criteria applies to individuals with limitations that could limit safe
participation in the study,

- such as metastatic cancer,

- multiple or recent (within six months) myocardial infarction (MI) or stroke,

- dialysis for end stage renal disease,

- severe psychiatric disease or dementia, or

- inability to walk without an assistive device.

- We will also exclude women who are pregnant at the time of study recruitment (based on
self report only) because of the unique needs related to diabetes self-management
during pregnancy.

- We will, however, retain women in the study should they become pregnant during the
course of the project.

- Individuals will be excluded if they plan to move out of the area.

- Additional exclusions may include inability to complete baseline tasks to the
satisfaction of the lead interventionist or other more subjective assessment
suggesting inability or unwillingness to adhere reasonably to the intervention based
on interventionist review.