Control IQ - FDA Approval target?

Hi all,

Anyone heard anything interesting recently about the Tandem/Dexcom Control IQ Closed Loop FDA approval? It was expected Q4 and, well, tick tock. They said on their last earnings call that they weren’t having any FDA issues, and that they expected to sell a boatload of pumps after FDA approval but before the end of the year. Since you need a prescription, that window is down to maybe 5-7 business days to get in to see your doctor.

I’d be curious if anyone has heard anything from their endo or Tandem/Dexcom reps.

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I have the same question, but not heard anything yet…

I’ve been scoping everything since the first week of November for news. They’re very tight-lipped. I’ve seen several comments from them that they can’t comment on pipeline products, because of the many facets of regulatory approval.

I’ve been paying cash for the G6, as cgms aren’t covered by my insurance, in anticipation of this “life-changing” update. Hopefully any day now!

I used to be the science officer for a smaller medical device company, so I’m all too familiar with the FDA runaround. Who knows what ridiculousness they’re nitpicking.

We also have a theory… The government is very good at creating new departments, and then not staffing them. We’re seriously wondering if they created this new “breakthrough device” designation, and haven’t bothered to staff the positions to process applicants. Or even if there’s a flow problem with the paper trail that hasn’t been worked out yet. (My pilot husband deals with the continuously within the FAA.). It may not have anything to do with the software.

NEWS!

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Recieved this email yesterday from Tandem. Partial excerpt:

Great news!
We just announced U.S. Food and Drug Administration (FDA) clearance of the t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed-loop technology. Control-IQ technology is designed to help prevent highs and lows by using Dexcom G6 continuous glucose monitor (CGM) values to predict sensor glucose levels 30 minutes ahead.* The t:slim X2 insulin pump then adjusts basal insulin accordingly, including delivery of automatic correction boluses as needed, to help increase time in range (70–180 mg/dL).†,‡

*Zero fingersticks required when using the t:slim X2 pump with Dexcom G6 continuous glucose monitoring (CGM) integration. If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. CGM sold separately.

As an in-warranty t:slim X2 insulin pump user, you will soon have the option to update your pump software to Control-IQ technology at your convenience, and at no additional cost.§

No action is required at this time
You will receive an email as soon as the software update becomes available. We expect to begin rolling out software updates in January 2020.

The process will be managed through an easy-to-use online portal. In the upcoming weeks, you will receive an email with instructions on how to get the process started. The process will consist of three steps:

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Continuation of above:

  1. Confirm your information

Through the portal, you will verify your contact and healthcare provider information. We will then start the prescription process with your designated healthcare provider.

  1. Online training

Once we receive your prescription from your healthcare provider, you will receive a link via email to complete your online training.

  1. Pump update

Once you have completed the online training, you will be ready to update your pump. We will email you a unique Update ID Code to complete the process via the Tandem Device Updater.

A computer and internet connection will be required for this process. System requirements and more information about the process can be found at tandemdiabetes.com/controliq-update.

Look for additional emails from us over the next few weeks.

Thanks for being a part of the Tandem family. We’re excited for you to see how easy control can be.

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CastAStone,
The FDA has approved the Control-IQ algorithm. The software update will be available for t:slim X2 pumps in January 2020. Visit https://www.tandemdiabetes.com/products/tandem-device-updater/control-iq to sign up for receiving an email notification.