Research

A pilot randomized controlled trial to evaluate the effects of education programs, including an interactive web site, on clinical outcomes in patients with diabetes.

Good control of blood sugar levels is important in preventing and reducing the complications associated with diabetes. Unfortunately, this is achieved in less than half of patients with type 2 diabetes. Aside from diet, exercise, and medications, diabetes education is considered to be an integral part of diabetes care. Diabetes self-management education (DSME) is the process of teaching individuals to manage their own disease.

Studies have found that there are significant knowledge and skill deficits in 50-80% of patients with diabetes. According to the U.S. Department of Health and Human Services, in 1998 only 40% of patients with diabetes were receiving formal diabetes education. Our goal is to see how effective a formal diabetes education program and an interactive diabetes website are on improving clinical outcomes and maintaining them in patients with diabetes.

Specific outcomes to be measured are hemoglobin A1c (which is a reflection of a glycemic control over the past three months), lipid profile (consisting of HDL, LDL, total cholesterol, and triglycerides), urine microalbumin (a measurement indicating amount of kidney disease from diabetes), blood pressure and weight. We will also measure if these interventions can improve patient's knowledge of diabetes and their quality of life. These parameters will be measured at baseline, then at given intervals and at the conclusion of the study.

In addition to continuing care with their primary care doctors, Phase I patients will be randomly assigned to either participate in a formal diabetes education program at the Gerald J. Friedman Diabetes Institute or to continue standard of care in their current clinical setting (i.e. GMA, Philips Family Practice). The standard of care will comprise of diabetes education as provided by their primary care doctor, nurse, and if available a diabetes educator and nutritionist.

Phase I of the study will continue for a period of nine months, at which point participants will enter Phase II of the study.

After nine (9) months in the study, patients in the previously described groups will be randomly assigned to continue in their current setting or receive access to an interactive diabetes website. This will result in the formation of four groups:

  1. Continued care in the formal diabetes education program for nine (9) months.
  2. A web-based diabetes education program for nine (9) months.
  3. Continued care in the primary care setting.
  4. An interactive web-based diabetes education program for nine (9) extra months

Specific topics to be covered are the same as those for the patients receiving "face-to-face" education in the diabetes center as mentioned above.

After a total of 18 months the study will conclude and the measured parameters from all groups will be calculated and analyzed. We will then determine the effectiveness and significance of a formal diabetes education program and interactive diabetes website on clinical outcomes in patients with diabetes.

The benefit of participation in this study may consist of improvement in any of the following: blood sugar levels, cholesterol levels, blood pressure, weight, knowledge of diabetes, and quality of life.