SAN DIEGO--(BUSINESS WIRE)--DexCom, Inc. (Nasdaq: DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today the publication and presentation of two new studies during the 14th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).
Focused on clinical outcomes of CGM use in broader and more diverse populations and new data from Dexcom’s next-generation G7 CGM, these two studies mark a pivotal moment in diabetes care innovation at one of the world’s leading industry conferences.
The MOBILE study, published in the Journal of the American Medical Association, is the first of its kind to find that people with Type 2 diabetes who use basal, or background, insulin, benefited from the use of CGM. With the publication of the MOBILE data, Dexcom has now demonstrated significant outcomes driven by its CGM technology in randomized controlled trials across the full spectrum of insulin use in people with diabetes.
Key clinical benefits of Dexcom CGM use in this population included:
- Increased time in range
- Significant A1c reduction
- More patients reaching A1c goals
- A profound decrease in hyperglycemia
The randomized clinical trial led by HealthPartners Institute’s International Diabetes Center and coordinated by The Jaeb Center for Health Research in Tampa, Fla. affirms Dexcom’s belief in the power of CGM for all people with diabetes regardless of Type.
“The clinical benefits of Dexcom CGM were seen across all patient demographics regardless of age, education, numeracy or socioeconomic status,” said David Price, MD, vice president of medical affairs at Dexcom. “The MOBILE study design also affirms our ability to meet the needs of the diverse communities we serve.”
MOBILE Study Findings
- The group of patients using Dexcom CGM spent an average of 3.8 hours more each day within the optimal range of blood glucose levels (70-180 mg/dL), 3.6 hours less each day in the very high glucose range (>250 mg/dL), and with a reduction in CGM measured hypoglycemia in the CGM group compared to the finger-stick glucose monitoring group
- 63% of patients using CGM to guide therapy adjustments had an HbA1c less than 8% compared to only 39% of patients using finger-stick glucose reading
- The group using CGM to guide therapy and lifestyle adjustments also had significantly lower HbA1c levels (9.1 to 8.0%) than the group of patients using traditional finger-stick glucose monitoring (9.0 to 8.4%); this was an adjusted difference in mean change in HbA1c of −0.4%, 95% CI –0.8% to −0.1%, P=0.02
- Adherence and satisfaction were also high among the CGM group
MOBILE Study Design
- Eight-month study of 175 ethnically and socioeconomically diverse adults (including >50% people of color) across 15 clinical sites
- Type 2 diabetes age 30 years or older who were receiving diabetes care from a primary care provider trying to manage their diabetes using basal or background insulin, but not using faster-acting insulin at meals
- Two-thirds of the trial participants were assigned to use Dexcom CGM and encouraged to use Dexcom’s CLARITY, Share and Follow software applications; the remaining one third of the trial patients were assigned to use the traditional blood glucose meter
Dexcom G7 Data
Dexcom also presented new data on its next generation interoperable CGM, Dexcom G7, drawn from clinical trials supporting the company’s efforts toward a CE Mark submission and US pre-pivotal work. The data represents the latest G7 technology, demonstrating the consistent performance of the sensor across the spectrum of glucose readings and duration of wear.
G7 Results (approximately 360 sensor sessions)
- An overall mean absolute relative difference (MARD) of 8.7%
- 93.8 percent %20/20
- 99% of sensor readings were clinically accurate and safe for treatment decisions
Expected Dexcom G7 Features and Benefits
- 60% smaller wearable than G6
- Smaller all-in-one sensor applicator and transmitter
- 30-minute warm-up
- Interoperability with insulin delivery devices
- Maintaining world class customer experience
- Continued best-in-class accuracy
“Initial clinical data has only strengthened our conviction that Dexcom G7 will build upon the high accuracy standard already established by our G6 CGM system,” said Jake Leach, executive vice president and chief technology officer at Dexcom. “The G7 is a completely redesigned CGM; our users will get a whole suite of new features that we believe will enhance the customer experience that has become synonymous with Dexcom.”
In addition to the MOBILE study and G7 data, many other presentations and posters from ATTD reinforced the benefits of Dexcom CGM for intensive insulin management, as well as its use in inpatient settings and during pregnancy.
About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked DexCom highest in customer satisfaction and loyalty. For more information, visit www.dexcom.com.