DexCom, Inc. (Nasdaq: DXCM), the world leader in continuous, real-time blood glucose monitoring for people with diabetes, announced today during the 14th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) the Publication and presentation of two new studies announced.
These two studies, which focus on the clinical outcomes of the use of continuous glucose monitoring (CGM) in broader and more diverse patient populations, as well as new data from DexCom’s next-generation CGM device, represent a pivotal moment in the Innovation in Diabetes Care at one of the world’s leading industry conferences.
The MOBILE study, which is part of the Journal of the American Medical Association published is the first of its kind to find that people with type 2 diabetes who use basal or background insulin have benefited from using CGM. With the release of the MOBILE data, Dexcom has now demonstrated significant results from its CGM technology in randomized controlled trials across the entire spectrum of insulin use in people with diabetes.
Key clinical benefits of using Dexcom’s CGM in this patient population include:
- More time in the measuring range
- Significant A1c reduction
- More patients achieve A1c goals
- A sharp decrease in hyperglycemia
The randomized clinical trial, led by the International Diabetes Center of the HealthPartners Institute and coordinated by the Jaeb Center for Health Research in Tampa, Florida, reaffirms Dexcom’s belief in the power of CGM for all people with diabetes, regardless of type .
“The clinical benefits of Dexcom’s CGM have been seen in patients from all demographics, regardless of age, education, numeracy, or socioeconomic status,” said Dr. med. David Price, Dexcom Medical Affairs Director. “The design of the MOBILE study also reinforces our ability to meet the needs of the different communities we serve.”
Results of the MOBILE study
- On average, the group of patients using Dexcom’s CGM spent 3.8 hours more per day in the optimal blood sugar range (70–180 mg / dl), 3.6 hours less per day in the very high blood sugar range (> 250 mg / dl) dl) and they experienced a reduction in the hypoglycaemia measured with CGM in the CGM group compared to the group with glucose measurement on the fingertip.
- 63% of patients who used CGM to adjust therapy had an HbA1c level of less than 8%, compared to only 39% of patients who had fingertip glucose testing.
- The group who used CGM to control therapy and lifestyle adjustments also had significantly lower HbA1c values (9.1 to 8.0%) than the group of patients who used traditional glucose measurement with a drop of blood from the fingertip (9 , 0 to 8.4%); this was an adjusted difference in the mean change in HbA1c of -0.4% (95% CI: -0.8 to -0.1%; p = 0.02).
- Therapy compliance and satisfaction were also high in the CGM group.
Design of the MOBILE study
- Eight-month long study with 175 ethnically and socio-economically different adults (including> 50% people of color) at 15 test centers.
- Type 2 diabetics aged 30 or over who were being looked after by a family doctor and trying to control their diabetes with basal or background insulin but were not using faster-acting insulin with meals.
- Two-thirds of the study participants were designated to use the Dexcom CGM and were encouraged to use the Dexcom software applications CLARITY, Share and Follow; the remaining third of the study participants were assigned the use of a conventional blood glucose meter.
Data from Dexcom G7
In addition, Dexcom presented new data on its compatible next-generation CGM device, the Dexcom G7, from clinical studies supporting the company’s efforts to obtain CE Marking, as well as from work prior to pivot studies in the United States. The data reflect the latest G7 technology and prove the consistent performance of the sensor across the spectrum of glucose readings and the length of time it was worn.
G7 results (approx. 360 sensor sessions)
- A total mean absolute relative difference (MARD) of 8.7%
- 93.8 percent% 20/20
- 99% of the sensor readings were clinically accurate and safe for treatment decisions
Expected Features and Benefits of the Dexcom G7
- 60% smaller carrying system than G6
- Smaller all-in-one sensor applicator and transmitter
- 30-minute warm-up phase
- Compatibility with insulin delivery devices
- Maintaining the great customer experience
- Still best in class accuracy
“Initial clinical data has reinforced our belief that the Dexcom G7 builds on the high level of precision our G6-CGM has achieved,” said Jake Leach, executive vice president and chief technology officer, Dexcom. “The G7 is a completely redesigned CGM device; our users will get a whole host of new features that we believe will enhance the customer experience that has become synonymous with Dexcom.”
In addition to the MOBILE study and the G7 data, many other presentations and posters from ATTD underpinned the advantages of the CGM from Dexcom for intensive insulin management as well as use in inpatient facilities and during pregnancy.
Über DexCom, Inc.
Headquartered in San Diego, California, DexCom, Inc. is dedicated to helping people better manage their diabetes symptoms through the development and marketing of continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. Thanks to the exceptional performance, patient comfort and lifestyle flexibility that are at the heart of DexCom technology, users have consistently rated DexCom the highest in terms of customer satisfaction and loyalty. More information is available at www.dexcom.com.
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