Experts convene to discuss glucose monitoring, call for improvement

Experts in all areas of diabetes management — patient care, technology, cost-effectiveness, industry and patients themselves — convened for a Consensus Conference on Glucose Monitoring in which they have each given their viewpoint and will debate next steps.

Irl B. Hirsch, MD, presented on the clinical applications of glucose monitoring, concluding that a specific infrastructure can help physicians make self-monitoring blood glucose and continuous glucose monitoring (CGM) most beneficial to patient care. Still, he said, the future of glucose monitoring is on the peripheral.

Irl B. Hirsch

“It’s possible that this conference this weekend … can make my peripheral vision centered,” Hirsch said.

Expert perspectives

On Sunday, leaders in the field of diabetes presented the latest in glucose monitoring technology, clinical applications, postmarketing surveillance and economic impact of glucose monitoring.

David C. Klonoff, MD, clinical professor of medicine at the University of California, San Francisco, presented the postmarket surveillance data, showing that many of the blood glucose monitors approved using ISO 2003 standards would no longer meet ISO 2013 standards.

David C. Klonoff

“Analytical inaccuracy of blood glucose monitors leads to incorrect insulin dosing, which causes more hypoglycemia, higher mean glucose levels and decreased accuracy of calibrated continuous glucose monitors,” Klonoff said. “A surveillance program for cleared blood glucose monitors will provide useful information to patients, health care providers and payers for selecting blood glucose monitors and to the FDA as signals of real-world product performance.”

Cost-effectiveness of glucose monitoring was covered by William H. Herman, MD, MPH, of the University of Michigan, who said the data for patients with non-insulin-treated type 2 diabetes is “remarkably sparse.”

“In this specific population, SMBG with or without training is associated with higher costs and lower quality of life,” he said. “It is unlikely to be cost-effective in addition to usual care.”

Other perspectives

Besides expert physician perspectives, Sunday’s session included presentations from the FDA, private insurance, large employers, industry and patient representatives.

Courtney H. Lias, PhD, from the FDA, discussed the need for regulation and the FDA’s goals in regulating glucose-monitoring devices and supplies.

“We strive for a balance between benefits and risks,” she said. “People with diabetes live with risks every day.”

Additionally, insurance and employer representatives discussed their approaches to coverage.

“We do not want to waste money treating folks when there isn’t going to be a benefit,” said Kenneth D. Snow, MD, who represented Aetna. “It is much easier to convince a payer to do the right thing if we know what the right thing is.”

Next step

On Monday, four breakout sessions — composed of medical, scientific, professional and educational societies; patient and lay organizations; government/regulatory/payors/employers; and industry — will work to answer four questions toward a consensus statement.

The questions to be answered are:

What data support glucose monitoring (as distinct from glycemic control) as a means to prevent diabetic macro- and microvascular complications?
Can the FDA improve post-approval surveillance of strip/meter/CGM quality?
Does current private insurance and Medicare policies balance the need to provide patient access to high quality care and effective glucose monitoring and, if not, what policy changes are needed with respect to: patient access to blood glucose monitoring supplies, patient access to CGM technology, limited or lack of coverage for sensor-augmented insulin pump therapy and emerging semi-automated CGM/pump combinations?

Each pillar will offer its answers to the aforementioned questions in presentations on Monday afternoon. After, the writing committee will convene and prepare a consensus statement to be presented in a congressional briefing Tuesday.

For more information:

See the Endocrine Today Twitter feed for live updates of the consensus meeting: www.Twitter.com/EndocrineToday.