Since I am no longer taking the oral medication Januvia, my GP suggested I keep a close eye on my glucose to make certain it remains within limits. You may recall from several previous blogs you can search on herein, that in the past I have paid for wearable glucose monitors myself, then Medicare started to pay, and I used one for about two years. Then, somehow, the FDA got involved and stated that the devices had not been cleared for those of us on dialysis. Medicare pulled support for the devices, leaving me to go back to the old school of finger pricks. That’s where I am again. Forty years as a diabetic and nothing’s changed.
So it is of interest to me where this all now stands. I quizzed Perplexity with the following Prompt and results:
Prompt: FDA Approval Status of Wearable Glucose Monitors for Dialysis Patients
No wearable continuous glucose monitors (CGMs) are specifically FDA approved for use in patients on dialysis or those with end-stage renal disease (ESRD). This is a key distinction: while several CGMs are FDA approved for people with diabetes, their use in the dialysis population remains off-label.
Details from Recent Research and FDA Statements
- According to diabetes technology experts and recent research, “these CGM devices… are not yet FDA approved for patients with ESRD on dialysis” due to the medical complexity of this population and their exclusion from most clinical trials111.
- Studies have shown that factory-calibrated CGMs (such as the Dexcom G6-Pro) can provide reasonably accurate glucose readings in dialysis patients, but these studies are not large enough to support FDA approval for this specific use111.
- The FDA has not cleared or approved any smartwatch or smart ring that measures glucose non-invasively (without skin piercing), for any population, including those on dialysis29.
Currently Approved CGMs
- The Dexcom G7, Abbott FreeStyle Libre 14-Day, and Eversense E3 are all FDA approved for people with diabetes, but not specifically for those on dialysis5671012.
- Over-the-counter CGMs such as Dexcom Stelo and Abbott Lingo have recently been cleared, but these are not indicated for people using insulin or those with problematic hypoglycemia, and there is no mention of approval for dialysis patients38913.
Off-Label Use in Dialysis
- Despite the lack of specific FDA approval, many clinicians and patients use CGMs off-label in the dialysis population due to their potential benefits and reasonable accuracy as shown in pilot studies111.
- If you are considering a CGM and are on dialysis, it is essential to discuss this with your healthcare provider, as they can help interpret the readings and manage any device limitations111.
Summary Table: FDA Status of Wearable Glucose Monitors for Dialysis
| Device Type | FDA Approved for General Diabetes? | FDA Approved for Dialysis/ESRD? | Notes |
|---|---|---|---|
| Dexcom G6/G7 | Yes | No | Off-label use in dialysis studied61011 |
| Abbott FreeStyle Libre | Yes | No | Off-label use in dialysis studied510 |
| Eversense E3 (implantable) | Yes | No | No specific dialysis approval710 |
| Dexcom Stelo (OTC) | Yes (non-insulin users) | No | Not for insulin users or problematic hypoglycemia389 |
| Abbott Lingo (OTC) | No (wellness only) | No | Not for diabetes management8 |
| Smartwatches/Smart Rings | No | No | No FDA approval for glucose measurement29 |
Key Takeaway
No wearable glucose monitor is FDA approved specifically for people on dialysis. However, off-label use of established CGMs is common, and emerging research supports their reasonable accuracy in this population, though further studies and regulatory review are needed before formal approval111. Always consult your healthcare provider before starting CGM use if you are on dialysis.
- https://newsroom.uvahealth.com/2022/06/29/off-shelf-glucose-monitors-prove-accurate-for-dialysis-patients/
- https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication
- https://www.ajmc.com/view/fda-approves-first-over-the-counter-continuous-glucose-monitor
- https://texasdiabetes.com/fda-approves-new-otc-continuous-glucose-monitor-cgm/
- https://www.abbott.com/corpnewsroom/products-and-innovation/freestyle-libre-14-day.html
- https://investors.dexcom.com/news/news-details/2022/Dexcom-G7-Receives-FDA-Clearance-The-Most-Accurate-Continuous-Glucose-Monitoring-System-Cleared-in-the-U.S/default.aspx
- https://www.fda.gov/medical-devices/eversense-e3-continuous-glucose-monitoring-system-p160048s016
- https://www.goodrx.com/classes/medical-supplies-and-devices/otc-continuous-glucose-monitor-faqs
- https://www.theregreview.org/2024/09/25/diaz-reducing-barriers-to-glucose-monitoring/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10012164/
- https://www.techtarget.com/virtualhealthcare/news/366597498/Continuous-Glucose-Monitors-Effective-RPM-for-ESRD-Patients
- https://www.ncbi.nlm.nih.gov/books/NBK279046/
- https://www.cardiometabolichealth.org/the-new-era-of-continuous-glucose-monitoring-cgm-expanding-access-and-improving-outcomes/
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