20070711

User Experiences with Glucose Meters

User Experiences with Glucose Meters

The FDA's Center for Devices and Radiological Health (CDRH) held a series of focus groups on blood glucose meter use in 2001. The twenty-two members participated in six groups. They were all government employees, mostly from CDRH. They were either people with diabetes or family members of people with diabetes who were familiar with the use of glucose meters.

Most of the participants in these groups were satisfied with their meters. Some were quite enthusiastic about the new models. A few had some concerns about meters. One such participant stated: "The first meter I got I couldn't use because it was too difficult."

Repeating Tests. Most users repeated tests now and then because they believed the first test result was incorrect. Users questioned test results based on their expectations about what the results should be. If the glucose level seemed "off," they repeated the test.

The ability to judge whether or not a test seemed accurate appeared to come from the users' experiences with their meters. These experiences helped them know how they felt when their glucose level was high, when it was low and when it was about right. They also were aware of what and when they had eaten, exercised, slept, or taken insulin, and they learned to anticipate the effect these activities have on their glucose levels.

Comments users made about their results include the following:

I sometimes get a reading of perhaps 300 and then 180 on a retest. This happens in about 1 in 50 tests.

Glucose tablet residue on my finger can throw results way off.

I get some inaccurate readings - especially when the meter is new.

Sometimes I get higher readings than I expect, probably because the meter was left out of the case or food got on it.

The date wears off of the vial and I end up using expired strips.

Humidity around the bathroom seems to affect performance of the strips.

If I have wet hands, my results tend to be higher than expected.
Besides repeating tests because of a suspected inaccuracy in the first test, a frequent reason to repeat a test was that the meter indicated "insufficient blood" on the test strip and would not complete the test on the first attempt. When this happens, users needed to do another fingerstick. Users whose meters required less blood did not have this problem as often.

Feelings about Fingersticks. Surprisingly, most of the participants stated that fingerstick discomfort was not a big concern - even with children: "At first, fingersticks were a real problem, but now it doesn't bother her."

Most participants stated that discomfort was an issue when they first started to use the meter; this was especially true for children, but that the discomfort grew less important after a few weeks or months of use.

However, one participant of a "fragile" child with diabetes stated: "We test 8 to 10 times a day. He was losing sensitivity in his fingertips [from the frequent fingersticks]. We prefer the meter that allows testing in alternative sites."

Use of Test Solution. Most users did not use test solution often. Some never used it. They stated that the solution was difficult to use because it expired in a month, it was difficult to order, and they were not convinced that it helped.

Important Features. Users discussed and rated aspects of meters such as accuracy, ease-of-use, cost of the meter, cost of test strips, size, whether it was recommended by a friend etc. The most important consideration in this group was accuracy. This was followed by "ease of use" and then affordability.