What is off-label use? Diagnosed in 1986 with type 1 diabetes, I had developed very few treatments beyond insulin that were approved and designed for me to use, especially as a kid. As I grew older, my pursuit of pregnancy limited my medication choices to those that were approved and proven to be safe for my child and me. But throughout my adult life, I constantly heard of people in the diabetes community using drug and device therapies off-label. It wasn’t until I ruled out future pregnancies (my endo was very conservative about discussing anything off-label once I was even casually thinking about pregnancy) that I began to pursue that path as well.

What is off-label use? The FDA cites “off label” use as “unapproved use of an approved medication,” signifying there aren’t studies to prove basic safety and benefits for populations or uses beyond the FDA approved one(s). In the diabetes community, that often means anything from use of approved closed-loop insulin pushes during pregnancy to the use of SGLT-2 inhibitors in people with type 1 diabetes. There are numerous medications approved for type 2 diabetes that could also benefit people with type 1 – and folks are hearing about them, prompting discussions with healthcare teams about using these remedies off-label. Things have changed in diabetes treatment over the entire years, with do-it-yourself (DIY) devices and off-label use talked about more openly.

‘re working to use those treatments ASAP and not looking forward to regulatory authorization. Sometimes, this means exploring treatments that are not yet approved for a particular use by the FDA but where anecdotal evidence is encouraging. However, even though you think a drug or device may be right for you, your healthcare team might not be comfortable with these discussions or prescribing the therapy.

Another huge barrier is coverage by insurance companies, because some remedies, when not included in insurance because they’re not approved for the condition, are extremely expensive. How will you get your healthcare team up to speed with off-label? Getting your care team to the desk for off-label discussions is definitely an exercise in honest and careful conversation, but consensus can be reached.

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In my experience, off-label conversations were next to impossible with my prior endocrinologist, but that’s mainly because I hadn’t eliminated future pregnancies at the time. I was past that probability Once, I transformed endocrinologists (just to be nearer to home). My new endocrinologist also offers type 1 diabetes. Raising issues with him was easier than with every other endocrinologist I’ve ever seen because he not only had the educational expertise, but he also walked the walk with type 1 diabetes himself. “Do you prescribe off-label?” I asked him during one of our first conferences.

“I do, with respect to the person and the circumstances,” he said. Which opened the floodgates of debate as I whipped out a list of therapies I’d found out about through the years and wanted more info. The very first thing I asked about was inhaled insulin. A GLP-1 agonist Then. Then, lots of talk about using different insulins in insulin pumps. For every topic, my doctor wanted to know why I needed to try it. He wanted to discuss the benefits and risks also, and how it matches my health background.

Understand the way the drug works, the huge benefits, and possible outcomes. Share examples of how the medication has been used effectively off-label. For Melissa Lee, who lives with type 1 diabetes, it offers often been her healthcare provider who raised off-label use as a choice, “but I doubt that’s the norm,” she said.

“I think it’s best to begin the discussion with some kind of study, a blog post, or anecdote you can indicate about having heard someone else using it off-label with success. Healthcare providers are usually convenient with something shown to be both effective and safe, anecdotally even. It’s helpful to have the ability to say, ‘I’ve heard that many people with type 1 diabetes have seen improvements in weight loss, insulin resistance, glucose management, etc., by using therapies originally intended for individuals with type 2 diabetes.