First I ever heard about this company “Sinocare” was when I took a call requesting patients for a two week clinical study of their True Vie I3 CGM system. The web site makes the Sinocare CGM sound pretty good! I went ahead and signed up, will be testing their CGM during February '24.
Curious if anybody has used Sinocare CGM and how they like it.
Sinocare Meditech – iCan Continuous Glucose Monitoring (ican-cgm.com)
Are they getting FDA or NMPA approval?
Not sure but I assume they are going for regulatory approval of a new sensor for their CGM? The study involves wearing 3 sensors at the same time for 15 days.
Their website says “Founded in 2002, Sinocare has a vision to become the leading diabetes digital management expert, worldwide. ”
I’ll keep everybody posted as I find out more…
What’s the purpose of each of the three sensors? Seems like a lot?
Sorry, I wasn’t very clear with my initial question.
Are they a Chinese company planning to release a medical device domestically with NMPA approval or are they a Chinese company planning to release a medical device internationally with FDA and EUMDR approval? Sounds like tbd…
Possibly internationally with FDA approval…but that is just a guess on my part. Here is more info about the study:
Study Details | Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial | ClinicalTrials.gov
The documentation says “You will be asked to either have 2 sensors on the abdomen and 1 on the arm, or 1 on the abdomen and 2 on the arms.” I’m guessing they are going with the “more is better” approach to collecting data.
Also, I just read through a document they will want me to sign to participate. It has a pretty broad confidentiality section that I will try to clarify with the study clinic to see what info I can or can’t share once this starts. I’m guessing they will want me to be pretty vague…
I like the idea of multiple sensors but it might drive me crazy if I could see all three on my phone?
They say for the 2 weeks I would still do my normal routine with Dexcom and Omnipod, so I will actually be wearing 4 sensors. I won’t be seeing the BG on the 3 study sensors all the time, only when they download the data
It will be interesting to see if all those sensors stay attached.
Any updates?
Yes @MarkP the study started last week and the 3 sensors are adhered, two abdomen and one on arm. They look very similar to Libre and will last 15 days.
I’ve had two visits to the clinic so far which have been well attended by a gaggle of nurses, doctors and attendants. It’s been interesting to chat with the docs about diabetes related things, always nice to hear various perspectives. The sensors we are testing are blinded though so nobody in the room has seen the BG data from them.