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Home » Could this agreement boost continuous glucose monitor use?

Could this agreement boost continuous glucose monitor use?

June 8, 2019 By Nancy Crotti

Senseonics’ Eversense continuous glucose monitor won FDA approval last year. (Image from Senseonics)

An international panel of patients, physicians and researchers has agreed upon evidence-based target glycemic ranges for people who use continuous glucose monitors (CGMs) to control their diabetes.

Announced today at the American Diabetes Association (ADA) conference in San Francisco, the International Consensus on Time-in-Range (TIR) was based on data from large pre-CGM clinical trials, CGM randomized controlled trials and expert opinion. It outlines recommended cut points that the panel agreed individuals with type 1 diabetes, type 2 diabetes and women with diabetes during pregnancy should strive to achieve.

In spite of CGMs’ increased accuracy and convenience, the devices’ use remains low in clinical settings, possibly due in part to the lack of official glycemic target ranges, the ADA said in a statement. The 43-member panel also strongly recommended creating a standard CGM report similar to the ambulatory glucose profile (AGP Report) to translate these new CGM targets into clinical practice.

The panel’s recommendations include:

  • A target range of 70-180 mg/dL [3.9-10.0 mmol/L] for individuals with type 1 or type 2 diabetes.
  • A target range of 63-140 mg/dL [3.5-7.8 mmol/L] during pregnancy.
  • A set of targets for the time per day [% of CGM readings or minutes/hrs].

The group also proposed setting conservative CGM targets for people with diabetes who are older and/or considered high-risk, with a strong focus on reducing the percentage of time spent <70 mg/dL (<3.9 mmol/L) and preventing excessive hyperglycemia.

Continuous glucose monitoring enables people with diabetes to respond immediately and appropriately to decrease or prevent acute glycemic events. The new target ranges would supplement the currently agreed-upon metrics for CGM-derived times within, below or above target ranges. The ranges could guide clinicians, researchers, and individuals with diabetes in using, interpreting and reporting CGM data in routine clinical care and research, the ADA said.

“Although unified recommendations for the use of key CGM metrics have been established, formal adoption by diabetes professional organizations, and guidance in the practical application of these metrics in routine clinical practice has been lacking,” said presenting author Dr. Tadej Battelino, head of pediatric and adolescent endocrinology at Ljubljana University Medical Centre in Slovenia, in a news release. “CGM has the potential to transform diabetes care and our group believes that clear, easy-to-understand and broadly agreed-upon glycemic targets for time-in-range levels will positively impact short- and long-term diabetes outcomes, particularly if understood and adopted by people with diabetes. It is critical for clinical care, regulatory oversight and research efforts related to CGM to all agree on standard core CGM metrics.”

The Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened the panel. The recommendations were published online today in Diabetes Care  as a manuscript titled, “Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations from the International Consensus on Time-in-Range.”

The report has been endorsed by the ADA, American Association of Clinical Endocrinologists, American Association of Diabetes Educators, European Association for the Study of Diabetes, Foundation of European Nurses in Diabetes, International Society for Pediatric and Adolescent Diabetes, JDRF, and Pediatric Endocrine Society.

CGM makers include Abbott (NYSE:ABT), Dexcom (NSDQ:DXCM),  Medtronic (NYSE:MDT) and Senseonics (NYSE:SENS).

Filed Under: Diabetes, Drug Pumps, Drug-Device Combinations, Featured, News Well, Research & Development Tagged With: American Diabetes Association

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