Potential breakthroughs in the management of diabetes could dramatically change the way the disease is controlled and treated. But these benefits will not be fully realized unless the manufacturers of a new generation of glucose monitors and those who design and use electronic medical records systems start thinking about integrating the new devices into physician practice patterns and information technology systems, according to a report from the New England Healthcare Institute.
A first generation of these monitoring systems is already in use. But they are "pretty primitive" and have approval from the Food and Drug Administration only for adjunctive use with the standard finger-stick method of drawing blood samples, says Valerie Fleishman, co-author of the 74-page NEHI report, "Continuous Glucose Monitoring: Innovation in the Management of Diabetes."
But, based on interviews institute researchers conducted with more than 100 experts in the field, in three to five years a second generation of continuous glucose monitors will have passed muster with the FDA, achieved payer acceptance and be in widespread use, Fleishman says.
Those new devices "have the potential to be highly valuable and cost-effective tools in managing diabetes, particularly for long-term, daily management," according to the report summary. They will be compact and minimally invasive and will share a common set of features that will make them popular as well as clinically effective. They will have:
The new systems stand to improve both the quality of care by helping patients tightly manage blood glucose levels -- achieved by just 37% of patients with diabetes today -- and patient quality of life "by providing a measure of freedom from blood glucose monitoring kits and minimizing disruption to daily activities."
What often happens is that new products are put on the market and only afterward are they integrated with information technology, but that would only delay maximizing the benefits of the new devices, Fleishman says.
"We are urging manufacturers and others to work together now to ensure that when these more advanced devices come online they are integrated into the clinicians' work flow, but also integrated into the physicians' technology," including EMRs, she says.
Dianne McLaughlin, communications manager for Medtronic MiniMed, the diabetes division of Medtronic and maker of a first-generation continuous glucose monitor as well as insulin pumps, says all of the key device elements outlined by the institute are valid "and many of those components are being tested today."
The new line of products will be out for public use much sooner than five years, McLaughlin says.
"For real-time reading and trend graphs, I would say two years," she says. "We expect to launch an insulin pump that integrates continuous glucose monitoring in a year's time."
The holdup for widespread use of these second-generation systems, from McLaughlin's view, will not be the technology but rather getting insurance companies, managed-care companies, self-insured employers and government payers to pay for the devices.
"It helps for payers to say they're going to reimburse this," McLaughlin says. "That really revs the market."
To that end, the institute recommends stakeholders develop consensus standards for accuracy of the new devices to expedite FDA approval and use the data gleaned from the regulatory approval process for use obtaining payer coverage.
Clinician acceptance of the new systems is also key to their widespread adoption, the report says. To boost adoption, "clinicians will need sufficient resources and support from a healthcare system that is not currently positioned to provide coordinated chronic care."
The not-for-profit institute, based in Cambridge, Mass., also recommended that patient groups, manufacturers, clinicians and payers work together to develop a coordinated approach to educate patients on how to best utilize the new devices.
View an executive summary or the full report.