A quick note from Gary…You Have A Right To Know Your Options.
Off-label. It’s a term used often in the medical world to describe the use of “approved” medications and devices for “unapproved” purposes. For example, for many years, continuous glucose monitors were government-approved for use by adults but not children. Why? Because the CGM manufacturers had not yet completed the required studies on CGM use in children. Nevertheless, many pediatric endocrinologists realized that the risk of using CGM in kids was far less than the risks they face every day by not using them. So, they prescribed them “off-label.” The same kind of off-label prescribing occurs for a variety of medications that are “approved” for use in patients with type-2 diabetes for use by patients with type-1.
Recently, the US Food & Drug Administration issued a warning against the use of do-it-yourself hybrid closed loop systems which use “approved” components, linked together in an “unapproved” manner. The warning was prompted by a single episode of hypoglycemia by a single person who was not using the system properly. The warning came despite the fact that thousands of people use these systems successfully, resulting in hundreds of thousands of fewer hypoglycemic events, dozens of avoided complications, and a whole lot more quality-of-life. (see our post on the topic: FDA Recommendations For Diabetes Management Are Largely Ineffective).
The point is, we believe that everyone with diabetes has a right to make an informed decision with the guidance of their healthcare team. There are plenty of approaches to diabetes management that DON’T work very well, so when we find something that does work, we’ll be sure to let you know.
So if you’re interested in finding out what’s new and perhaps getting a little bit creative with your diabetes care, give us a call. We’ll be happy to discuss the pros and cons of anything that might benefit you. Call us crazy, but we think you deserve to know all of your options. Even if the FDA disagrees.
Gary Scheiner MS, CDE
Owner & Clinical Director