Yesterday evening I received a call from the EversenseCGM rep I blogged about yesterday. As expected, their device HAS NOT been approved for use by PD patients nor could he express any confidence that it would work as advertised for us/them. So write them off for now.
I turned to Perplexity with the Prompt: Has any CGM been approved for use by Peritoneal Dialysis patients and received the following response:
Based on the search results provided, there does not appear to be any continuous glucose monitoring (CGM) systems that have explicit FDA approval specifically for use by peritoneal dialysis patients. However, there are some relevant points to consider:
- General CGM approvals: Several CGM systems have received FDA approval for general use in people with diabetes, including the Dexcom G6, Abbott Freestyle Libre, and Eversense systems[3][4][5]. These approvals do not specifically mention peritoneal dialysis patients.
- Dialysis patient exclusions: Historically, patients with end-stage renal disease (ESRD) on dialysis have often been excluded from clinical trials for CGM devices[1][2]. This has limited the available data on CGM accuracy and effectiveness in this population.
- Recent studies: Some recent research has begun to evaluate CGM use in dialysis patients, including those on peritoneal dialysis. For example, a study mentioned in search results [5] found a good correlation between CGM and blood glucose meter values in dialysis patients.
- Off-label use: While not explicitly approved, some CGM devices may be used off-label in peritoneal dialysis patients under the guidance of healthcare providers.
- Future developments: The FDA has shown interest in expanding access to CGM technology. The recent approval of the first over-the-counter CGM (Dexcom Stelo) for adults not on insulin therapy suggests a trend toward broader availability[6].
In summary, while there is no specific FDA approval for CGM use in peritoneal dialysis patients, ongoing research and evolving regulatory approaches may lead to more explicit guidance or approvals for this population in the future. Patients on peritoneal dialysis should consult with their healthcare providers to determine if CGM use is appropriate for their individual situation.
Citations:
[1] https://newsroom.uvahealth.com/2022/06/29/off-shelf-glucose-monitors-prove-accurate-for-dialysis-patients/
[2] https://www.hcplive.com/view/off-shelf-cgm-can-provide-accurate-readings-in-patients-on-dialysis
[3] https://www.fda.gov/news-events/press-announcements/fda-approves-first-continuous-glucose-monitoring-system-fully-implantable-glucose-sensor-and
[4] https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-fully-interoperable-continuous-glucose-monitoring-system-streamlines-review
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC10012164/
[6] https://www.ajmc.com/view/fda-approves-first-over-the-counter-continuous-glucose-monitor
[7] https://www.ncbi.nlm.nih.gov/books/NBK279046/
[8] https://www.fda.gov/media/112212/download
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