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Contact: Tonya Ewers, 303.315.6374, pager 303.266.0941, Tonya.Ewers@ucdenver.edu
Study: Continuous Glucose Monitors Can Help Type 1 Diabetes Patients Better Control Their Diabetes
Findings are considered valuable to the future of diabetes management
AURORA, Colo. (Sept. 8, 2008) - Researchers at the Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver participated in a recent multi-center clinical diabetes study that found patients with type 1 diabetes who regularly use continuous glucose monitoring (CGM) devices to help manage their disease, experience significant improvements in blood sugar control when the devices are used consistently. The study was funded by the Juvenile Diabetes Research Foundation and will be published online this week by the New England Journal of Medicine and in the journal’s October print edition.
The JDRF-funded researchers at 10 sites including private providers, academic centers, and a managed care plan, reported that faithful use of CGM devices (6-7 days/week) enabled patients with type 1 diabetes to reduce HbA1c—a marker of blood glucose levels—more effectively than standard glucose monitoring alone. Standard glucose monitoring includes the well-known finger prick testing method.
“These results are incredibly important, because they show that continuous glucose monitors are more than simply devices of convenience for people with diabetes – they are tools that can dramatically improve blood sugar control when used regularly,” said Dr. Rosanna Fiallo-Sharer, co-investigator on the study at the Barbara Davis Center for Childhood Diabetes clinic site. “Based on the findings of previous studies, better control of glucose levels over the long term could translate to a lower risk of complications for people with type 1 diabetes.”
Approximately 320 patients were assigned to either CGM or a control group using standard glucose monitoring and were followed for 26 weeks to assess effects on blood sugar control, mainly assessed by measurement of the HbA1c level. At enrollment into the study, patients had HbA1c levels of 7 to 10 percent (the goal for adults with type 1 diabetes generally is a level below 7 percent and for children and adolescents it is below 7.5-8 percent). Three age groups were analyzed separately: 8 to14 years of age, 15 to 24 years of age, and 25 or older.
Improvements in blood sugar control were greatest for patients who were assigned to the continuous glucose monitors group and were 25 years of age or older. In this group of patients, HbA1c levels decreased (improved) during the study by an average of 0.53 percent compared with control patients (p<0.001); improvements in secondary measurements were also significantly greater in CGM patients, including the percentage of patients able to achieve an HbA1c level below 7 percent. The improvement in HbA1c occurred without an increase in hypoglycemia (low blood sugar), which is the worry when attempting to tighten glucose control. In children aged 8 to 14 years old, the average decrease in HbA1c was not significantly different in the CGM and control groups; however, those in the CGM group were more likely to lower their HbA1c by at least 10 percent and achieve HbA1c levels below 7 percent compared with the control group. Fifteen- to 24-year-old CGM patients, as a group did not experience significant improvements in glucose control compared with the control group.
CGM use varied with age, averaging at least six days a week over the course of the trial in 83 percent of the patients 25 years and older, but dropping off to 30 percent in the 15- to 24-year-old age group and 50 percent in the 8- to 14-year-old age group (for whom CGM use typically involved their parents’ assistance). Although the study was not specifically designed to assess the effect of frequency of CGM use on HbA1c, an analysis presented Sept. 8 at the European Association for the Study of Diabetes (EASD) annual meeting in Rome suggested that patients within all three age groups, including teens and young adults, who used the device at least six days a week had substantially lower HbA1c levels after six months compared with patients who used CGM less than six days a week.
“This research was 25 years in the making,” said Dr. Peter Chase, a co-author on the study from the Barbara Davis Center for Childhood Diabetes at the UC Denver School of Medicine. “I consider this to be one of the most important findings in clinical diabetes research to-date. We still have a long way to go but the results of this study represent the future in diabetes management.”
The lower levels of regular CGM use among children and teenagers observed in this study underscore the importance of continued research into a closed-loop artificial pancreas—a device that uses CGM data to administer appropriate doses of insulin through a pump without the need for involvement of the patient or for young children their parents.
The CGM study was a randomized, controlled trial involving 322 patients spanning the age range of 8 to 72 years at 10 sites, which included academic, community, and managed care based practices at the Atlanta Diabetes Associates, the Joslin Diabetes Center, Kaiser Permanente Southern California, Nemours Children’s Clinic—Jacksonville, Fla., the Lucile Packard Children’s Hospital at Stanford University, the Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver, the University of Iowa, the University of Washington, and Yale University, and coordinated by the Jaeb Center for Health Research in Tampa, Fla. Results from the study were presented Sept. 8 at the European Association for the Study of Diabetes (EASD) annual meeting in Rome
The University of Colorado Denver School of Medicine faculty work to advance science and improve care as the physicians, educators and scientists at University of Colorado Hospital, The Children’s Hospital, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. Degrees offered by the UC Denver School of Medicine include doctor of medicine, doctor of physical therapy, and masters of physician assistant studies. The School is part of the University of Colorado Denver, one of three universities in the University of Colorado system.
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About Type 1 Diabetes
Type 1 diabetes is an autoimmune disease that affects children, adolescents, and adults, in which the immune system attacks cells in the pancreas that produce insulin, a hormone that enables people to convert food into energy. People with type 1 diabetes are dependent on insulin for the rest of their life. But insulin is not a cure, and people with diabetes are at significant risk for a wide range of serious complications, including heart disease, blindness and kidney disease. As many as 3 million people in the U.S. have type 1 diabetes.
About CGM Devices
CGM devices, manufactured by several companies and approved by the FDA as an adjunctive therapeutic for diabetes, provide both a real-time snapshot of the glucose levels of a person with diabetes, as well as trend information on whether glucose is moving upwards or downwards, and how fast. Devices also provide warnings when the glucose is becoming too high or too low.
About JDRF
JDRF is the leading charitable funder and advocate of type 1 (juvenile) diabetes research worldwide. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes children suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation.
Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.16 billion to diabetes research, including more than $156 million in FY2008. In FY2007, the Foundation funded more than 1,000 centers, grants and fellowships in 22 countries.
CGM devices, improved glycemic control, and artificial pancreas technologies are key areas of research within JDRF’s Metabolic Control cure therapeutic focus. In addition to improving the quality of life for people with type 1 diabetes, cure therapeutics impacting metabolic control reduce the risk of developing the various complications of diabetes, and will likely enhance the effectiveness of ability of other research leading to a cure.