Dexcom Solidifies Global Leadership in Continuous Glucose Monitoring With New Clinical Data Presented at EASD

Rhea-AI Summary

DexCom announces new clinical study outcomes at the 59th Annual Meeting of the European Association for the Study of Diabetes, highlighting the benefits of CGM use and the expanding portfolio of automated insulin delivery offerings.

Positive

• Dexcom's COMISAIR study shows significant and continued reduction of HbA1c with real-time CGM use by people with Type 1 diabetes.
• Use of Dexcom ONE CGM system leads to significant HbA1c reduction for people with Type 1 and Type 2 diabetes.
• Dexcom G7 and Dexcom G6 are the only CGM systems with clinical studies demonstrating accuracy during pregnancy for women with Type 1, Type 2, and gestational diabetes.

Negative

• None.

• COMISAIR study is now the longest prospective real-world CGM study ever conducted, demonstrating significant and continued HbA1c reduction for patients using real-time CGM over seven years.¹
• New data shows the Dexcom ONE CGM system delivers a clinically meaningful increase in time in range, reduction in HbA1c and improved glucose control for users with Type 2 diabetes.²
• Based on a recent study of 96 pregnant women presented at EASD 2023, Dexcom G7 and Dexcom G6 are now the only commercially available CGM systems with clinical studies demonstrating real-time CGM is accurate for use during pregnancy for women with Type 1, Type 2 and gestational diabetes. ^‡,3,4
• As new clinical data continues to affirm Dexcom real-time CGM is central to optimal diabetes management, Dexcom is launching new automated insulin delivery systems and driving rapid expansion of access to CGM globally.

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ: DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today new clinical study outcomes that further demonstrate the benefits of CGM use and offered more details about its expanding portfolio of automated insulin delivery offerings at the 59th Annual Meeting of the European Association for the Study of Diabetes held Oct. 2-6, 2023 in Hamburg, Germany.

The leader in real-time CGM and the clear choice for automated insulin delivery

New results from the COMISAIR seven-year study, the longest prospective real-world CGM study ever conducted, show significant and continued reduction of HbA1c with the use of real-time CGM by people with Type 1 diabetes. Regardless of insulin delivery method, multiple daily injections or insulin pump therapy, real-time CGM has greater and statistically significant HbA1c reduction when compared to self-monitoring blood glucose over seven years.^* The COMISAIR study also shows further substantial reduction in HbA1c when real-time CGM is connected to an automated insulin delivery system, specifically Tandem Control IQ.^† In addition, the study showed high CGM adherence over seven years, regardless of insulin delivery method, 88.8% for those using CGM and multiple daily injections and 91.9% for those using CGM and AID.^‡

With the latest data from the COMISAIR study reaffirming the effectiveness of AID in improving diabetes management, Dexcom continues to strengthen its position as the world’s most connected CGM system, announcing the Dexcom G7 CGM system will begin launching with the Tandem t:slim X2 insulin pump before the end of the year in the U.S. and multiple markets across Europe and Asia-Pacific. This news follows the recent launch of the Omnipod 5 Automated Insulin Delivery System connected to Dexcom G6 in the UK and Germany.

“Dexcom is the undisputed leader in connectivity and has safely powered AID systems for more than 1 million years of cumulative patient use,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “We’ve prioritized connectivity for more than a decade, which means our CGM systems are optimized to seamlessly connect with insulin delivery and digital health partners of all kinds, giving users freedom of choice in their diabetes journey and making Dexcom the clear choice for AID.”

The CGM brand for people with Type 2 diabetes

In addition to the successful results from the COMISAIR study, a new single site study with Jackie Elliot, PhD, FRCP, as the primary investigator, shows use of the Dexcom ONE CGM system by people with both Type 1 and Type 2 diabetes on intensive or basal insulin leads to significant HbA1c reduction.² The Dexcom ONE prospective study shows use of Dexcom ONE in Type 2 subjects reduced HbA1c from 10.1% to 8.5% over three months and further reduced HbA1c to 8.3% at six months.

By funding and supporting new studies that explore the efficacy of real-time CGM among those with Type 2 diabetes, Dexcom is working to improve access and expand reimbursement for more people around the world, giving them the tools they need to improve their metabolic health, lead healthier lives and stop disease progression.

“Championing access to real-time CGM technology for people with all types of diabetes is central to our mission at Dexcom,” said Alex Moussa, senior vice president and general manager of EMEA & LATAM at Dexcom. “With Dexcom G7, Dexcom G6 and Dexcom ONE, we have the most complete portfolio of CGM systems for people with all types of diabetes and we continue to work on expanding access to our life-changing technology. We have recently celebrated product launches and changes to reimbursement criteria that make CGM more accessible in Argentina, Australia, Belgium, Bulgaria, France and Japan. We know the extraordinary results that real-time CGM can deliver. It’s the technology everybody living with diabetes deserves.”

The CGM systems for use during pregnancy

A new study with Carol Levy, MD, as lead investigator, featured at EASD, shows Dexcom G7 is accurate overall during pregnancy and across all sensor wear days and all glucose ranges for pregnant women with Type 1, Type 2 and gestational diabetes.^||,3 Dexcom G7 and Dexcom G6 are now the only commercially available CGM systems with clinical studies demonstrating real-time CGM is accurate when used by people with Type 1, Type 2 and gestational diabetes during pregnancy.^3,4 In addition to the Dexcom G7 pregnancy accuracy study, Dr. Levy also reviewed the study protocol and objectives from the AiDAPT study led by Helen Murphy, MBBChBAO, MD, FRACP, which is the largest randomized control trial of an AID system versus standard insulin delivery in pregnant women with Type 1 diabetes and early results show women using AID spend significantly more time in target glucose range than those not using AID.⁵

Dexcom Education Sessions at EASD 2023

Leading the Way Through the Diabetes Journey for HCPs and Patients
Monday, Oct. 2, 2023, 13:30-15:00 CEST, Mumbai Hall

• Speaker: Bernhard Kulzer, MD, PhD
  Dexcom G7: The German perspective
• Speaker: Jan Soupal, MD, PhD
  Dexcom real-time CGM clinical outcomes: The 7-Year COMISAIR data
• Speaker: Carol Levy, MD, CDCES
  Dexcom CGM in pregnancy: Outcomes and accuracy – the AiDAPT study and G7 accuracy
• Speaker: Jackie Elliott, PhD, FRCP
  Dexcom ONE: Real-world outcomes and new innovative technologies

Leading the Way with Accuracy and Connectivity
Tuesday, Oct. 3, 2023, 14:45-15:15 CEST, Spotlight Theatre

• Speaker: Partha Kar​, MBBS, MD, FRCP
  Updates to new NICE technology assessment for AID systems
  Dexcom G7 and Tandem Control IQ, coming soon
• Speaker: Jan Soupal, MD, PhD
  New data on 7-year COMISAIR outcomes
  Real-time CGM is the technology that provides safety, convenience and precision to diabetes management

Leading the Way with the Most Device Features Designed to Support Diabetes-Related Safety and Efficacy
Friday, Oct. 6, 2023, 10:00-10:30 CEST, Spotlight Theatre

• Speaker: Tadej Battelino, MD, PhD
  Cognitive decline and working memory complications associated with lower time in range
  How CGM and AID systems can be used more effectively in various patient populations to improve outcomes​
• Speaker: Sufyan Hussain, MA, MB BChir, MRCP, PhD
  Dexcom G7 has the most device features designed to support diabetes related safety and efficacy
  Dexcom G7 is simple to start, easy to use and helps lower the burden of diabetes management
  Dexcom G7 has exceptional accuracy for better informed treatment decisions

For more information about these presentations and to register to virtually attend the conference, visit https://easd.org.

About DexCom, Inc.

DexCom, Inc. empowers people to take real-time control of health through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, Calif., and with operations across Europe and select parts of Asia/Oceania, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom works to simplify and improve diabetes management around the world. For more information on Dexcom, visit www.dexcom.com.

Category: IR

^*7.1% (MDI+rtCGM) vs. 7.7% (MDI+SMBG). ^†6.6% (AID – Tandem Control IQ) vs. 7.7% (CSII+SMBG). ^‡88.8±7% (MDI+CGM) and 91.9±4.1% (AID+CGM). ^||Dexcom G7 overall accuracy in pregnancy as measured by %20/20 agreement rate was 92.5% for all women with diabetes (T1, T2 and GDM).

¹ Soupal, J. Dexcom rtCGM clinical outcomes: The 7-Year COMISAIR data. Presented at EASD, 2023; October 2. Hamburg, Germany. ² Elliott, J. Dexcom ONE: Real-world outcomes and new innovative technologies. Presented at EASD, 2023; October 2. Hamburg, Germany. ³ Levy, C. Dexcom CGM in pregnancy: Outcomes and accuracy – the AiDAPT study and G7 accuracy. Presented at EASD, 2023; October 2nd. Hamburg, Germany. ⁴ Castorino K, et al. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2020;22(12):943-947. ⁵ Murphy, H. AiDAPT study. Presented at ADA, 2023; June 25. San Diego, CA; USA.

Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. ©2023 Dexcom, Inc. All rights reserved.

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Source: DexCom, Inc.