Home fructosamine testing: is its demise premature?

Abstract

643 GIVEN THE PROJECTED INCREASE in the U.S. population of the number of people with type 2 diabetes and the resulting negative financial impact to our society, the need for inexpensive new methods of screening large groups and better monitoring tests for those determined to be at risk of hyperglycemia is paramount. The gold standard test, A1C, has dropped in price, and at least two home test versions are known to this author: one in a mail-in test, the other an “at home test” that gives results in about 8 min. In theory, these A1C tests could be used for public screening and the results reviewed by health professionals on site, but A1C values are not known to show significant changes in glycemic control in less than 2–3 months. This relatively long interval to determine a change in control could result in missing those with glucose intolerance and gestational diabetes. When performing public health screenings it is common to find subjects who have changed their dietary and exercise habits and medication compliance immediately prior to the scheduled test. Most want to achieve the best possible “score,” making blood glucose values unreliable. The use of long-term markers such as the A1C test for screening purposes increases the chance of missing persons at the early stages of risk. The development of the medium-term marker fructosamine as a portable home test created the possibility of a rapid, inexpensive test that could be used for determining average glycemic control over a 10–14-day period. This shorter time frame should present the opportunity to quickly perform retrospective evaluation of changes in diet and exercise habits, possibly allow faster evaluation of changes in medication dosages, and serve as an inexpensive rapid screening test for impaired glycemic control. My colleagues and I set out to determine if fructosamine testing could be of value in monitoring persons with diabetes by creating a multisite, randomized, controlled trial. The 3-month results in the preceding article1 are worth noting. While the results had not reached the statistically significant point, there was enough evidence to encourage us to continue to enroll subjects for a follow-up period of 1 year. Additional data were collected for 6 months providing evidence that the difference had continued to grow, which indicated that this may be a method of self-monitoring that could result in better overall glycemic control when compared with currently accepted blood glucose self-monitoring standards. Our 6month results abstract has just been reviewed and accepted for presentation as a poster at the Second Annual Diabetes Technology Conference in Atlanta, GA on November 1 and 2, 2002. Additionally, we have collected 9 months of data from a majority of the currently enrolled subjects and have just finished following subjects at one site for 12 months. We intend to complete data collection, evaluate the evidence, and will present our final results for peer review.