FDA News

FDA clears Dexcom G6 Professional CGM System

The FDA on Tuesday approved the use of a professional continuous glucose monitoring system from Dexcom, according to a press release from the company.

Glucose measures are tracked for 10 days with the system, which is marketed as the Dexcom G6 Pro CGM System.

Blinded and unblinded modes are available with the system, according to the release. Patients who employ the blinded mode use the system without access to data until visiting with a physician or other provider to review the data. Patients who opt for the unblinded mode have access to data during all stages of the process.

The system can be used with patients with diabetes aged 2 years or older and, according to the release, includes other features, such as an easy sensor application; disposable, single-use sensor; the elimination of fingerstick calibration;, an auto-start transmitter; and integration with the Dexcom CLARITY application.

“Dexcom G6 Pro will enable health care providers to set up their patients with CGM in minutes,” Davida Kruger, MSN, APN-BC, BC-ADM, a diabetes specialist in the division of endocrinology, diabetes, bone and mineral disorders at Henry Ford Health System in Detroit, said in the release. “This new professional system will serve as a simple way to obtain data from CGM naïve patients who need glucose insight, but don’t need or want to be monitored around the clock. It will give all my patients a chance to try the Dexcom G6 Pro under a health care provider’s supervision before they commit to a personal system.”

This Dexcom system is one of several professional CGM devices that have reached the market, including the Dexcom G4 Platinum Professional, Abbott’s Free Style Libre Pro CGM System and the Medtronic iPro CGM system. However, Dexcom describes the G6 system as “the first and only single-use, professional CGM that gathers real-time glucose data over a 10-day period and offers both a blinded and unblinded mode.”

As Endocrine Today previously reported, professional CGM systems are prescribed by health care providers who then review the data collected by the system with patients after a wear time of 14 days or fewer. – by Phil Neuffer

Disclosure: Endocrine Today could not confirm relevant financial disclosures at the time of publication.

The FDA on Tuesday approved the use of a professional continuous glucose monitoring system from Dexcom, according to a press release from the company.

Glucose measures are tracked for 10 days with the system, which is marketed as the Dexcom G6 Pro CGM System.

Blinded and unblinded modes are available with the system, according to the release. Patients who employ the blinded mode use the system without access to data until visiting with a physician or other provider to review the data. Patients who opt for the unblinded mode have access to data during all stages of the process.

The system can be used with patients with diabetes aged 2 years or older and, according to the release, includes other features, such as an easy sensor application; disposable, single-use sensor; the elimination of fingerstick calibration;, an auto-start transmitter; and integration with the Dexcom CLARITY application.

“Dexcom G6 Pro will enable health care providers to set up their patients with CGM in minutes,” Davida Kruger, MSN, APN-BC, BC-ADM, a diabetes specialist in the division of endocrinology, diabetes, bone and mineral disorders at Henry Ford Health System in Detroit, said in the release. “This new professional system will serve as a simple way to obtain data from CGM naïve patients who need glucose insight, but don’t need or want to be monitored around the clock. It will give all my patients a chance to try the Dexcom G6 Pro under a health care provider’s supervision before they commit to a personal system.”

This Dexcom system is one of several professional CGM devices that have reached the market, including the Dexcom G4 Platinum Professional, Abbott’s Free Style Libre Pro CGM System and the Medtronic iPro CGM system. However, Dexcom describes the G6 system as “the first and only single-use, professional CGM that gathers real-time glucose data over a 10-day period and offers both a blinded and unblinded mode.”

As Endocrine Today previously reported, professional CGM systems are prescribed by health care providers who then review the data collected by the system with patients after a wear time of 14 days or fewer. – by Phil Neuffer

Disclosure: Endocrine Today could not confirm relevant financial disclosures at the time of publication.