Power to the People! How the Voice of People with T1D Can Influence Regulatory Decisions

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One of the most commonly discussed topics on Glu over the years has been about the importance of getting continuous glucose monitors (CGMs) covered by Medicare. Until recently, CGM had been classified as an adjunctive device, meaning that it complemented care, and thus, didn’t fit into a category that Medicare would cover.

But in January 2017, the Centers for Medicare and Medicaid Services (CMS) announced they would recognize a recent FDA decision that classified CGM as durable medical equipment.

This is an important step that lays the groundwork for Medicare covering CGM. As stated in an announcement by JDRF, this process has lasted more than a decade, and has been a significant advocacy effort involving many voices in the type 1 community. Did you know that data from the T1D Exchange helped influence this important decision?

A Dotted Line

Data from two T1D Exchange studies supported the FDA decision of their categorization of CGMs; the REPLACE BG study and a study examining hypoglycemia in older people.

The REPLACE BG study was a trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in adults with type 1 diabetes. This study was recently published in Diabetes Care following a presentation at the 10th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) this past week in Paris. The FDA also received the data from the T1D Exchange Registry analysis and from a second clinic study analyzing hypoglycemia in older adults. The analysis from the T1D Exchange Clinic Registry data found that 21% of people over the age of 65 who had T1D for more than 40 years reported seizures or loss of consciousness due to a severe hypoglycemic episode—a percentage far greater than what was previously understood.

The Danger of Hypoglycemia Unawareness

Evidence from a second study was also presented to regulators which demonstrated, using CGM, that hypoglycemia was common in older adults—a population who frequently relies on Medicare for access to diabetes supplies.

Approximately two hundred participants in 18 clinical centers around the country participated in the study.

  • Half of participants had experienced a severe hypoglycemic event in the past year, and half had not experienced one in at least three years (“controls”).
  • Daily insulin intake was about the same for each group, but in the case of people who experienced severe hypoglycemia in the past year, more had hypoglycemic unawareness and there was greater glucose variability but not lower A1cs. Overall, on 53% of days, glucose levels were less than 70 mg/dL for 20 min or longer; 20% of case subjects stated they did not feel hypoglycemia until their glucose was less than 40 mg/dL.
  • Only 11% of older adults with severe hypoglycemia over the past year reported always feeling symptoms of a low blood sugar (compared to 43% of controls); 17% (vs 6%) reported never or rarely feeling any symptoms at all. In addition, there was more impairment in some cognitive testing in adults with severe hypoglycemia over the past year. Not surprisingly, these adults had more fear of hypoglycemia.

Dr. Ruth Weinstock, one of the researchers in the study, said, “Hypoglycemia is a major problem in older adults with type 1 diabetes, and can cause significant problems such as seizures, loss of consciousness, heart problems (arrhythmias) and falls with fractures. CGM and low glucose threshold-suspend insulin pumps can be useful tools to help reduce hypoglycemia. Some of the centers from T1D Exchange will be conducting a randomized trial to evaluate the use of CGM in older adults with T1D, specifically to determine if hypoglycemia can be reduced and quality of life improved using CGM.”

As the FDA considered its decision, we presented data from the T1D Exchange Clinic Registry, a database of information on more than 26,000 people living with type 1 diabetes. According to the Registry, only 26% said they always confirmed their CGM reading with a fingerstick before deciding how much insulin to give. 41% said they dosed insulin more than half the time without checking on a meter.

Learning from the Voice of Glu

In December of 2016, we asked two questions on Glu (the T1D Exchange online community for people touched by T1D) that were used to supplement the evidence being presented, so you helped in this effort, too!

What’s Next

CGM isn’t covered by Medicare yet, but T1D Exchange will continue to gather and present compelling evidence—directly from our T1D community of participants—to ensure that people with T1D get access to devices and medications they need.

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