For these new meters, once the blood is placed on the test area, the meter times the reaction and delivers a glucose reading. While SMBG has proved its worth for hundreds of thousands of diabetics, there have been many complaints about inaccurate results and difficult meter maintenance. The manufacturers of the meters are obligated by law to report such occurrences to FDA, which regulates medical devices and monitors medical devices that present problems for users. User error seems to be involved in many complaints about inaccurate results. According to the American Diabetes Association, about 27 percent of diabetics are visually impaired, and 25 percent have loss of sensation in hands or feet or problems in moving fingers.
Many diabetics have a low education level with below average reading skills.
In addition, a substantial number of diabetic patients are Hispanics with a limited command of English. We know something is going wrong. This Consensus Development Conference on Self-Monitoring of Blood Glucose, attended by many health professionals and representatives from the medical device industry, probed questions about the usefulness and efficacy of SMBG under conditions ranging from use in hospitals to use in summer camps by children with diabetes. In the view of the health professionals and regulators of the health industry, the test kits had proved their potential therapeutic value, and physicians had encouraged many Type II diabetics to use SMBG to monitor their blood glucose. The second most important finding of the conference was that the blood glucose meters should be made easier to use, and that the users should be better trained in their operation.