From the Journals

Better trials, more cooperation needed to improve continuous glucose monitoring devices



When continuous glucose monitoring (CGM) devices were first introduced, many thought they would revolutionize intensive insulin therapy for patients with diabetes. More than 15 years later, uptake is increasing but still remains low.

An expert working group convened by the American Diabetes Association and the European Association for the Study of Diabetes is seeking to change that with recommendations designed to improve the use and clinical value of CGM devices (Diabetes Care. 2017 Oct 25. doi: 10.2337/dci17-0043).

“The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes,” John R. Petrie, MD, of the University of Glasgow, Scotland, and members of the working group wrote in the joint scientific statement.

Barriers to the uptake of CGM devices include cost and “human factors” issues such as the need for more audible alarms and easier-to-read displays, according to the joint statement. A lack of standardization in displaying results and uncertainty over the best way to use CGM data are also obstacles to widespread adoption.

The working group called for a systematic premarketing and postapproval evaluation of CGM system performance, as well as greater investment in clinical trials, including head-to-head comparisons and large independent registry studies. Other recommendations include the need for standardization of glucose data reporting, improved consistency and accessibility of postmarketing safety reports, and increased communication and cooperation between the various stakeholder groups.

The most important recommendation from the working group is the call for stakeholders to cooperate and communicate regularly, said A. Jay Cohen, MD, medical director of the Endocrine Clinic in Memphis, Tenn.

“That’s going to drive the momentum of change that’s going to help patients, and it’s also going to drive innovation,” he said.

After reviewing the joint scientific statement, Dr. Cohen said he would strongly encourage collaboration between stakeholders in government, insurance, clinical practice, industry, and patients to advance the use of CGM systems.

“The CGM systems have been not evolutionary, but revolutionary, in improvement in care for persons with diabetes and their families,” Dr. Cohen said. “They are a game changer, and besides … this unequivocally saves employers and insurers money, so it’s very cost effective in a very intuitive way.”

The joint scientific statement is based on review of more than 50 data sources, including recent clinical trials, research abstracts, regulatory authority databases, manufacturing company documents, and the clinical experience of the committee members.

“The guidelines set forth by this scientific statement will greatly inform providers and further advance the standardization, accuracy, and safety of CGM systems,” William T. Cefalu, MD, chief scientific, medical, and mission officer of the ADA, said in a statement.

Most members of the working group have relationships with industry, but industry “is considered to have had no impact on the manuscript or its content by reviewers from the ADA and EASD.”

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