The FDA will hold a July 21 advisory panel meeting to discuss a landmark issue in CGM: whether it should be officially approved for dosing insulin. The diaTribe Foundation will be submitting a letter to the FDA conveying its support for using Dexcom's G5 CGM for making treatment decisions. The more support in the form of signatures the letter has, the more powerful it will be.
Read our letter summary below and add your signature by Wednesday, July 13!
Scroll to the bottom of this page to add your signature, and read the full letter here.
The diaTribe Foundation's Letter to the FDA
RE: Docket No. FDA-2016-N-0001
July 21 Meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
The diaTribe Foundation and members of the diabetes community signed below are pleased to submit comments to the Food and Drug Administration (“FDA” or “Agency”) regarding the July 21 meeting to discuss a change in intended use of Dexcom’s G5 Mobile CGM.
We support the application to enable patients to use the Dexcom G5 device as a replacement for their blood glucose meters (BGM) and to make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.
Neither BGMs nor CGMs are perfect devices, but we ask the FDA to consider: (i) the existing risks and dangers of use BGMs alone for making treatment decisions; and (ii) the additional safety layers CGM adds to diabetes decision making.
As the FDA weighs all the risks and benefits of approving this PMA supplement, we hope the following comments will be considered.
- Many currently available blood glucose meters used for insulin dosing fail to meet ISO and FDA accuracy criteria, and may be less accurate than Dexcom’s G5.
- Many patients and healthcare providers feel that CGM is safer than BGM with the addition of real-time data (288 readings per day), alarms, trend arrows, and remote monitoring. CGM adds redundancy for making safer diabetes decisions.
- Many current CGM users already use the information to make treatment decisions; however, proper patient and healthcare provider education cannot occur without this label update.
- CGM can minimize the risk of a false high caused by dirty hands, a concern for safe dosing of insulin.
- A replacement claim for CGM is needed before Medicare will even consider coverage, and these are the patients most in dire need of CGM.
- Dexcom’s G5 already has BGM replacement label claims in Europe. We urge the FDA to reach out to its European counterparts to learn from this experience.
- Blood glucose meters are not currently FDA approved for dosing insulin or making treatment decisions, and some were cleared over 10 years ago under more lenient accuracy criteria. Why are CGM devices held to a higher standard?
- A replacement claim could expand the number of patients willing to go on CGM and the number of providers willing to prescribe it.
- Insulin is a highly dangerous drug, and equipping a wider spectrum of patients with more comprehensive real-time data and alarms could prevent hospitalizations.
- Diabetes is a highly burdensome, 24/7 disease, and the quality of life benefits from fewer fingersticks should also be factored into the FDA’s decision.
READ THE FULL LETTER HERE for in-depth commentary on each of these points. This letter is what we will submit to the FDA, signed by the signatures collected below.
With this meeting, the FDA has a historic opportunity to protect patient safety, promote public health, enhance patients’ quality of life, and promote next-generation product innovation.
Thank you so much for the opportunity to bring patient perspective to this important meeting.
Kelly Close, Adam Brown, Ava Runge, and the following members of the diabetes community.
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