In first trial of its kind, UNC study
shows checking finger-stick blood sugars may not help diabetes patients not
on insulin.
University of North Carolina Health Care
In a landmark study, UNC School of Medicine researchers have
shown that blood glucose testing does not offer a significant advantage in
blood sugar control or quality of life for type 2 diabetes patients who are not
treated with insulin.
The paper, published in JAMA Internal Medicine,
details findings from a randomized trial called "The MONITOR Trial."
This study is the first large pragmatic study examining glucose monitoring in
the United States.
Type 2 diabetes is an epidemic afflicting one in 11 people in
the United States. For those treated with insulin, checking blood sugar with a
finger stick at home is an accepted practice for monitoring the effects of
insulin therapy.
However, the majority of type 2 diabetes patients are not treated with insulin. These patients, too, are often recommended glucose monitoring, despite an ongoing debate about its effectiveness in controlling diabetes or improving how patients feel.
"Our study results have the potential to transform current
clinical practice for patients and their providers by placing a spotlight on
the perennial question, 'to test or not to test?'" said Katrina Donahue,
MD, MPH, senior author of the study and Professor and Director of Research at
UNC Family Medicine.
During the study, 450 patients were assigned to one of three
groups: no blood sugar monitoring, once daily glucose monitoring, or enhanced
once-daily glucose monitoring with an internet-delivered tailored message of
encouragement or instruction.
The trial lasted one year. By the end:
- There were no significant differences in blood glucose control across the three groups.
- There were no significant differences found in health-related quality of life.
- There were no notable differences in hypoglycemia (low blood sugar), hospitalizations, emergency room visits. Between programs, there was also no difference in the number of individuals who had to start using insulin treatment to better control blood sugar levels.
"Of course, patients and providers have to consider each
unique situation as they determine whether home blood glucose monitoring is
appropriate," Donahue said. "But the study's null results suggest
that self-monitoring of blood glucose in non-insulin treated type 2 diabetes
has limited utility. For the majority, the costs may outweigh the
benefits."
Today in the U.S., most of the 25 million people with type 2
diabetes do not take insulin. They control their blood sugar with exercise,
diet, and sometimes medications such as metformin.
Currently, 75 percent of
these patients also perform regular blood glucose testing at home, generally at
the recommendation of a provider.
Proponents of blood glucose testing argue that daily testing
promotes better awareness of glucose levels, leading to improvements in diet
and lifestyle. In the past, a number of smaller clinical trials have shown
mixed results in attempting to verify this.
Several studies suggested a benefit
for testing, while others found no evidence of benefit, or found that testing could
even be harmful. Daily testing imposes not only a financial cost, but can also
take a mental toll, increasing the rate of depression or anxiety in some
patients.
"There was no difference between either type of
testing," said UNC endocrinologist Laura Young, MD, PhD, the paper's first
author. "Enhanced Self-Monitoring Blood Glucose, in the pragmatic setting
of regular daily life, offered no additional health benefits."
"There has been a lack of consensus, not just in the United
States, but worldwide," added Young. "The lack of standard guidelines
makes it all the more difficult for patients, who are already struggling to
manage a chronic condition. And at the end of the day, patients have to make a
choice."
Patients living with diabetes should discuss the need for blood
sugar monitoring with their health care providers.
If together a patient and
their provider decide that blood sugar monitoring is not necessary, patients
could be spared hundreds of finger sticks and save hundreds of dollars every
year, at least until insulin treatment is required.