# iWel CGM (small Pennsylvania company, beyond vaporware but not yet available in US/EU) **URL:** \ **Category:** C/GM\ **Created:** [March 25, 2018, 4:05pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788 "2018-03-25T16:05:57Z")\ **Posts on this page:** 13\ **Page:** 1
**Author:** ![bkh](https://avatars.discourse-cdn.com/v4/letter/b/da6949/32.png) [@bkh](https://forum.fudiabetes.org/u/bkh)\ **Post date:** [March 25, 2018, 4:05pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/1 "2018-03-25T16:05:57Z")
There’s an interview of the head of a small CGM company that I hadn’t heard of. They claim to have 56,000 patients using their CGM. [http://www.diabetesincontrol.com/david-zeng-transcript/](http://www.diabetesincontrol.com/david-zeng-transcript/) Their features are smaller needle, smaller transmitter, reading on the phone app every 3 minutes, 1-week sensor life, 1 calibration per day. Two search keywords are iWel and Glutalor. They had a booth at ADA '17, and their home page is [https://www.glutalormed.com/](https://www.glutalormed.com/) ---
**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\ **Post date:** [March 25, 2018, 4:53pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/2 "2018-03-25T16:53:10Z")
That is really intriguing. I am surprised by the interview. In 2016, they were not yet approved in the EU. Their management team is not listed on the website site. The HQ is in Pennsylvania. How did this small US company get 56,000 patients in Europe in 1 year? ---
**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\ **Post date:** [March 25, 2018, 5:13pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/3 "2018-03-25T17:13:15Z")
I am extremely skeptical. The answers were some of the worst answers I have ever read. The interview sounded like speaking with a classic snakeoil salesperson. Spin and evasion. I do not think it was said that the “56,000” or whatever number were from Europe but rather they were from “other countries”. This sounds 100% like a Chinese company trying to masquerade as a US Based company. I would be totally wrong. But that is the smell right off the bat. ---
**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\ **Post date:** [March 25, 2018, 5:16pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/4 "2018-03-25T17:16:20Z")
Animas had 90,000 pump customers. Tandem has 50 ~ 60,000 pump customers. Senseonics has nearly 2,000 unique users on Eversense in Europe. This company supposedly has 50 or 56,000 users? ---
**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\ **Post date:** [March 25, 2018, 5:18pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/5 "2018-03-25T17:18:46Z")
[http://en.sanmeditech.com/](http://en.sanmeditech.com/) “In May, 2005, the “short-term” continuous glucose examination system of DEXCOM was approved by the FDA, and in November, 2005, the Chinese SFDA authorized San Meditech’s Dynamic glucose monitoring system (DGMS®).” ![image](https://canada1.discourse-cdn.com/flex030/uploads/fudiabetes/original/2X/9/9bb141239099167f0eb1db8fd2e517933e3b9f7c.jpg) ![image](https://canada1.discourse-cdn.com/flex030/uploads/fudiabetes/original/2X/6/679a27fa84f29b8730c31eb8f617841e0f23bcf4.jpg) ![image](https://canada1.discourse-cdn.com/flex030/uploads/fudiabetes/original/2X/1/1e30cd4c4943d085d8266a534d5a9e5a0783a17f.jpg) ---
**Author:** ![bkh](https://avatars.discourse-cdn.com/v4/letter/b/da6949/32.png) [@bkh](https://forum.fudiabetes.org/u/bkh)\ **Post date:** [March 25, 2018, 8:05pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/6 "2018-03-25T20:05:20Z")
> [@Thomas](#): > > This sounds 100% like a Chinese company trying to masquerade as a US Based company. I concur with your assessment. What I can’t tell is whether they actually have a decent product. They claim they are preparing their FDA submission and are aiming for US product launch in late '18. So we’ll have to read the FDA submission to get any indication of plausibility. ---
**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\ **Post date:** [March 25, 2018, 8:08pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/7 "2018-03-25T20:08:06Z")
> [@bkh](#): > > So we’ll have to read the FDA submission to get any indication of plausibility. Are the FDA submissions public? I would LOVE to be able to read the FDA submissions. I HATE having to take the word of companies as it relates to FDA submissions. My first guess is they may have a patent issue or two. But that is 100% pure speculation based on absolutely nothing. ---
**Author:** ![MM2](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/mm2/32/3032_2.png) [@MM2](https://forum.fudiabetes.org/u/MM2)\ **Post date:** [March 25, 2018, 9:28pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/8 "2018-03-25T21:28:15Z")
Wonder how it will compare with Medtronics latest standalone CGM. > **[Medtronic Launching Stand-Alone CGM: Guardian Connect](https://www.healthline.com/diabetesmine/new-medtronic-stand-alone-cgm-guardian-connect)** > > In early March, FDA approved Medtronic Diabetes new Guardian Connect the company's first-stand alone continuous glucose monitoring system in years. ---
**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\ **Post date:** [March 25, 2018, 10:03pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/9 "2018-03-25T22:03:10Z")
@MM2 Quite the enthusiastic article !!! ---
**Author:** ![bkh](https://avatars.discourse-cdn.com/v4/letter/b/da6949/32.png) [@bkh](https://forum.fudiabetes.org/u/bkh)\ **Post date:** [March 25, 2018, 10:30pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/10 "2018-03-25T22:30:26Z")
> [@Thomas](#): > > Are the FDA submissions public? I would LOVE to be able to read the FDA submissions. I stand corrected. As you say, the pre-approval submission probably is treated as highly proprietary. I was vaguely remembering the PMA documents that appear on the FDA site, like the Dexcom G4 item in [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120005](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120005) but on checking back I see that those reports only come out after the FDA gives its approval. ---
**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\ **Post date:** [March 25, 2018, 10:33pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/11 "2018-03-25T22:33:49Z")
> [@bkh](#): > > I stand corrected. As you say, the pre-approval submission probably is treated as highly proprietary. Darn. I thought you had an access to share. 😄 (That would have been excellent. lol) ---
**Author:** ![Eric](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/eric/32/9209_2.png) [@Eric](https://forum.fudiabetes.org/u/Eric)\ **Post date:** [March 25, 2018, 11:44pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/12 "2018-03-25T23:44:43Z")
> [@Thomas](#): > > I am extremely skeptical. > > … > > This sounds 100% like a Chinese company trying to masquerade as a US Based company. When I read the interview, I also picked up a few clues. * * * ![image](https://canada1.discourse-cdn.com/flex030/uploads/fudiabetes/original/2X/9/9afda59192c2ddbeea08d4825d6c4651d21f97b6.png) ---
**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\ **Post date:** [March 25, 2018, 11:45pm UTC](https://forum.fudiabetes.org/t/iwel-cgm-small-pennsylvania-company-beyond-vaporware-but-not-yet-available-in-us-eu/3788/13 "2018-03-25T23:45:56Z")
Totally. I saw that Facebook ad and knew there was something fishy going on. 😈