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Recommendations issued to boost CGM technology use

By Editor
1st November 2017
Medical devices

Greater investment in trials and improved consistency of safety reports are among new recommendations issued to help continuous glucose monitoring (CGM) technologies achieve full potential.

The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have joined forces to release the document.

It features 31 specific recommendations aimed at the relevant stakeholders — regulatory agencies, manufacturers, researchers/academics, research funding bodies, patient groups, health professionals, and medical associations.

A panel of experts led by Professor John Petrie, of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow, wrote the document based upon an extensive review of over 50 pieces of literature. It also includes information from recent clinical trials, research abstracts, regulatory authorities and manufacturing companies as well as the team’s own clinical experience.

Despite “great progress” in CGM technology in recent years, Professor Petrie and colleagues wrote: “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 organisations is required for the necessary trials to be conducted and for the field to progress.”

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 recommendations note that while CGM devices have been studied primarily for the use of people with type 1 diabetes, there is limited evidence to support the use of CGM in people with type 2 diabetes. Additionally, insufficient proof of clinical utility and reliability, along with lack of consistent reimbursement are both cited as contributing factors to the limited use of CGM across large populations of people with diabetes. Additionally, the authors said that CGM was critically important technology for the future outlook of automated insulin delivery systems, which combine CGM devices with insulin pumps.

The recommendations fall under five main themes:

  1. More systematic and structured premarketing evaluation of the performance of CGM systems.
  2. Greater investment in trials to provide evidence of CGM value and reliability for all patient groups.
  3. Standardisation of CGM-measured glucose data reporting from clinical trials.
  4. Improved consistency and accessibility of safety reports to regulatory authorities after market approval.
  5. Increased communication and cooperation across stakeholder groups.

The panel wrote: “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 utilisation, and greater resources reinvested to support innovation.

 To read the research, click here.

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