Study Published Today in Diabetes Care Journal Shows Dexcom(TM) SEVEN(R) CGM Intervention Group With Significantly Better Glucose Control Than Self-Monitoring Blood Glucose Alone
SAN DIEGO, CA -- (MARKET WIRE) -- 11/22/11 -- Dexcom, Inc. (NASDAQ: DXCM) -- Real-time, continuous glucose monitoring (CGM) is effective in improving blood glucose control in people with Type 2 diabetes, reveals a study published online today in Diabetes Care, a leading journal on diabetes research and management. This is the first time that real-time Continuous Glucose Monitoring (CGM) has been studied in a large U.S.-based, randomized-controlled trial in people with Type 2 diabetes. Most studies have demonstrated that real-time CGM is effective in patients with Type 1 diabetes, or patients using intensive insulin treatment of both basal and meal time insulin.
The 52-week randomized controlled study at Walter Reed Army Medical Center found that real-time CGM is significantly better at controlling blood glucose in people with Type 2 diabetes than the more traditional method of self-monitoring of blood sugar (SMBG) at meal times and bedtime.
The study examined 100 patients with Type 2 diabetes who were not on meal-time insulin, and were treating their diabetes with a variety of medications. Patients were randomized to either pre-meal/bedtime self-monitoring of blood glucose or to a Dexcom™ SEVEN® CGM in four cycles (two weeks on, one week off) for three months. The devices were then removed and all patients were observed for nine months while undergoing regular care from their usual provider.
For the first three months of the study, when patients were actively using the device, A1c decreased 0.9% from baseline compared with 0.4% for the SMBG group. After another nine months of observation there was a sustained reduction of 1.1% in the RT group, compared to 0.5% in the SMBG group. The A1c is a three month measure of diabetes glucose control. Patients who used real-time CGM more frequently during the first three months of intervention showed even greater glucose lowering over time with a drop in A1c compared to baseline. Declines in A1c between the CGM group and the SMBG group were statistically significant. Importantly, weight change was greater in the first 12 weeks in the real-time CGM group although it was similar between the two groups at the end of a year. The improvement in A1c was achieved with fewer patients in the real-time CGM group having been started on insulin compared with the SMBG group.
"To our knowledge, this is the first study that has used real-time CGM in this population that is typical of people with Type 2 diabetes. Since the study team did not make any recommendations about medication usage, we speculate that real-time, continuous blood sugar monitoring gave patients an increased awareness of the glycemic changes in their bodies, in response to what they ate, drank and when they exercised," said the study's primary investigator Robert A. Vigersky, M.D., COL., M.C. "As a result of their increased awareness, participants may have made healthy lifestyle decisions and adhered to their medication regime."
There was no specific training offered to participants on how to respond to the real-time CGM data, suggesting that the Dexcom™ SEVEN® CGM was intuitive for patients to use for managing their diabetes.
"For years, we've known that real-time continuous glucose monitoring with the Dexcom SEVEN was effective in people with Type 1 diabetes," said Terrance Gregg, Dexcom Chief Executive Officer. "This is a major, U.S.-based, controlled trial demonstrating the value of Dexcom SEVEN for all types of diabetes. The fact that improvement continued up to a year even after patients stopped using the device shows it's a powerful behavior modification tool. And what's even more exciting is the fact that A1c improvements surpassed the benefits of many drugs designed for Type 2 diabetes. We believe that early use of real-time CGM could affect the course of this disease and look forward to additional research showing the extent of its effectiveness."
CGM Puts Patients in Control
Dexcom's CGM technology shows people with diabetes where their glucose is, where it is going and how fast it's getting there -- something finger sticks could never show. It provides a new glucose reading every five minutes for up to seven days of uninterrupted wear-time. This helps people stay within their target range, and alerts the patient if his or her blood sugar is too high or low, both of which can be life-threatening. Dexcom is the only sensor that the U.S. Food and Drug Administration has approved for up to seven days of wear.
Prescribed by a physician and covered by most insurance plans, the Dexcom CGM consists of just three parts: a sensor, transmitter and monitor. The sensor, about the width of two human hairs, is applied by the user to the abdomen with a tiny attached transmitter, which sends data wirelessly to a monitor. About the size of a small cell phone, the monitor fits easily in a purse or pocket. The system provides the control and confidence that people with diabetes need to effectively manage their blood sugar and stay in control.
About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for ambulatory use by patients and by healthcare providers in the hospital. The Dexcom Seven CGM is the only sensor FDA-approved for up to seven days of wear.
Cautionary Statement Regarding Forward Looking Statements
DexCom is a medical device company with a limited operating history. Successful commercialization of the company's products is subject to numerous risks and uncertainties, including a lack of acceptance in the marketplace by physicians and patients, the inability to manufacture products in commercial quantities at an acceptable cost, possible delays in the company's development programs, the inability of patients to receive reimbursement from third-party payors and inadequate financial and other resources. Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company's annual report on Form 10-Q for the period ending September 30, 2011, as filed with the Securities and Exchange Commission on November 2, 2010.
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