Self-Blood Glucose Monitoring Yields No Significant Improved Control In Non-Insulin Users With Type 2 Diabetes
Chicago, IL (June 26, 2007) - Regular self-monitoring of blood glucose, at least by people with type 2 diabetes who do not use insulin injections, did not result in a clinically significant reduction in blood glucose control in a year-long study, according to a report presented today at the American Diabetes Association's 67th Annual Scientific Sessions.
"No self-monitoring was compared to two different intensities of self-monitoring, and no clinically significant different reductions were seen in results on A1C tests," reported Andrew J. Farmer, FRCGP, DM, University Lecturer, University of Oxford, and Principal Investigator of the Diabetes Glycemic Education and Monitoring (DiGEM) study in a recent interview. A1C tests measure blood glucose control over a two- to-three-month period. "Further, no additional effect of a more intensive self-monitoring regimen was observed."
Dr. Farmer emphasized that these results do not apply to people with type 1 or 2 diabetes who take insulin injections because there is already substantial evidence of the benefits of self-monitoring to help prevent hypoglycemia and to adjust medications, diet, and physical activity to optimal levels in those individuals.
Nearly 21 million Americans have diabetes, a group of serious diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Diabetes can lead to severely debilitating or fatal complications, such as heart disease, blindness, kidney disease, and amputations. It is the fifth leading cause of death by disease in the U.S. Type 2 diabetes involves insulin resistance - the body's inability to properly use its own insulin. Type 2 used to occur mainly in adults who were overweight and ages 40 and older. Now, as more children and adolescents in the United States become overweight and inactive, type 2 diabetes is occurring more often in young people.
NEED FOR DiGEM
Self-monitoring of blood-glucose (SMBG) for non-insulin treated diabetes is costly but has been believed to lead to improved blood glucose control. However, existing evidence has been inconclusive and previous trials have been multi-factorial, with people receiving self-monitoring and other interventions at the same time. Hence, it is not clear whether it is the SMBG or another factor that may be responsible for improvements in glycemic control.
Thus, the goal of the DiGEM trial was to determine whether SMBG, either alone or with additional instruction in incorporating test results into self-care, is more effective than standard medical care in improving glycemic control in people with non-insulin treated type 2.
DiGEM METHODOLOGY
People with type 2 were recruited from 48 family practices. After screening, 453 adults (average age 65.7, 57% male) were randomized to one of three groups:
* Standard medical care, with no SMBG, in which they saw their physician for an A1C test once every three months (the control group); * SMBG at least six times a week, with results logged in a book and shared with the research nurse every three months for interpretation ─ although subjects were told to seek a physician's help if blood glucose levels fell above or below certain pre-defined levels - (the less intensive group); * SMBG at least six times a week, after individual training, with phone and clinic follow-up to interpret and apply the results of testing to enhance motivation, goal-setting, dietary maintenance, physical activity and medication regimens (the more-intensive group).
RESULTS
An intention-to-treat analysis was performed with the primary outcome of 12-month A1C adjusted for baseline values. Everyone in the program was included, because roughly the same number dropped out in all groups. At 12 months, 57 patients (13%) were lost to follow up.
At the end of the year, 66% of patients receiving the less intensive intervention and 52% of those in the more intensive intervention had persisted in self-monitoring more than twice a week over the 12-month period.
At baseline, mean A1C across the groups was similar at 7.5%. At 12 months, the results were again similar. The mean A1C difference between the control and less-intensive self monitoring group was -0.14%, and between the control and more-intensive self-monitoring group -0.17%. The differences between the three groups were not statistically significant (P=0.12).
"A difference of -0.5% or more would generally be needed for a therapy to be considered clinically effective, and we powered the study to be able to see a difference that large if it existed, but we did not get it," said Dr. Farmer.
"Patients, clinicians and policy-makers will need to look at the results to reach decisions about appropriate use of SMBG technology," he said. "The results of this trial will add to the evidence available to make the decisions."
Co-authors of the study with Dr. Farmer were: Alisha N. Wade, MD, Johns Hopkins Bayview Medical Center, Baltimore; Elizabeth Goyder, MD, University of Sheffield; Pat Yudkin, DPhil and Andrew Neil, FRCP, University of Oxford; and Ann-Louise Kinmonth FRCP, University of Cambridge. The study was funded by the Health Technology Assessment Programme, which is part of the UK National Institute for Health Research.
The American Diabetes Association is the nation's leading voluntary health organization supporting diabetes research, information and advocacy. Founded in 1940, the Association has offices in every region of the country, providing services to hundreds of communities.
For more information, please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit
www.diabetes.org. Information from both these sources is available in English and Spanish.
Late-breaking Studies Symposium
Embargoed until: Tuesday, June 26 8:25 am CDT Contact: Diane Tuncer, (703) 299-5510 Elizabeth Magsig, (703) 549-1500, ext 2146 NEWS ROOM June 22 - 26, 2007: Room E270, McCormick Place Convention Center; Voice (312) 949-3210; Fax (312) 949-3218
2007
