New recommendations from two major diabetes organizations aim to overcome the barriers that have kept continuous glucose monitoring (CGM) technologies from achieving their potential to “revolutionize” intensive insulin therapy.
“Improving the clinical value and utility of CGM systems: Issues and recommendations: A joint statement of the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group” was published online October 25, 2017 in Diabetes Care and in Diabetologia .
The authors were a panel led by John R Petrie, of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, Scotland. The same group published a statement on insulin-pump safety in 2015.
Despite “great progress” in CGM technology in recent years, Dr Petrie and colleagues write, “insufficient evidence of clinical utility and reliability and the lack of consistent reimbursement contribute to limited use of CGM across large populations of people with diabetes who could potentially benefit.
“A more concerted commitment to seeking robust evidence by industry, regulators, clinical and technical experts, and funding and patient organizations is required for the necessary trials to be conducted and for the field to progress,” they stress.
This will include the incorporation of CGMs as key components of automated insulin-delivery systems and their intermediate iterations, including sensor-augmented insulin pumps and “hybrid” closed-loop systems.
The document summarizes the considerable data showing benefit of traditional CGMs — as well as the FreeStyle Libre , a so-called “flash” monitoring system that is termed “intermittently scanned CGM” (isCGM) — in patients with type 1 diabetes and the more limited data suggesting benefit for some patients with type 2 diabetes who use insulin.
Despite Considerable Trial Data on CGMs, Much More Research Needed
However, the authors point out several limitations to the numerous studies conducted so far, including few participants with recent history of severe hypoglycemia, lack of head-to-head comparisons between CGM and isCGM systems, lack of standardization in outcomes, and insufficient guidance for patients on how to use the CGM data to make therapeutic decisions.
Moreover, they contend, these weaknesses in the data, along with a dearth of cost/benefit studies, are partly responsible for the heterogeneity in reimbursement for the technologies in the United States and Europe.
The document makes 31 specific recommendations aimed at the relevant stakeholders — regulatory agencies, manufacturers, researchers/academics, research funding bodies, patient groups, health professionals, and medical associations — and falling under five main themes:
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More systematic and structured premarketing evaluation of the performance of CGM systems.
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Greater investment in trials to provide evidence of CGM value and reliability for all patient groups.
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Standardization of CGM-measured glucose data reporting from clinical trials.
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Improved consistency and accessibility of safety reports to regulatory authorities after market approval.
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Increased communication and cooperation across stakeholder groups.
“We envision an ongoing role of the [American Diabetes Association, the European Association for the Study of Diabetes], and other professional medical associations in supporting the virtuous cycle of CGM innovation, confirmation of value to users, increased utilization, and greater resources reinvested to support innovation,” the panel writes.
They add, “For this vision to be realized without further delay, we call upon regulators and manufacturing companies to work urgently with health professionals and people with diabetes to create an environment with much greater standardization of outcome measures, a high level of attention to safety issues, and full transparency of adverse-event reporting.”
Travel costs for the panel were covered by the ADA and EASD. Dr Petrie has served on an advisory board for one company manufacturing medical diagnostic devices (Alere) and for a number of companies manufacturing pharmaceuticals used in the treatment of diabetes. Disclosoures for the coauthors are listed in the paper.
Diabetes Care. Published online October 25, 2017. Article
Diabetologia. Published online October 25, 2017. Article
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