It's constituted: Tandem Diabetes Care now has approval from the FDA for its t:slim G4 combo system, which is integrated with the Dexcom G4 continuous glucose monitoring device. On Wed morning, the Calif. pump company announced that the FDA had approved its first combo device on Sept. 8 — about 14 months afterwards Tandem Diabetes submitted the system for review. This marks Tandem's third gimmick favorable reception since debuting in Venerable 2012 (first the t:slender, then the larger t:flex pump and now the combo system).

In the foregone year piece Tandem bicycle was awaiting approval, competitor J&J's G4-combo Animas Vibe system got the FDA commons light and hit the grocery in January. That makes this t:slim G4 the secondly ticker to offer improved-in Dexcom CGM integration and the third combo arrangement overall fanny Medtronic's line of CGM-pumps.

Receive, t:slim G4!

The good news show is that it's e'er exciting to see our Diabetes Community get some other choice as far as tools to help us pursue landscaped wellness outcomes.

The corked news is the timing: Tandem's new jazz band device is nearly obsolete on arrival given that last Free fall, Dexcom rolled out an advanced algorithmic rule that's more accurate than its original G4 and that spick-and-span algorithmic rule is not enclosed hither. Moreover, Dexcom's G5 guide-to-smartphone sensor was too just approved by FDA and bequeath comprise ready in the coming weeks — putting Tandem another square behind the latest tech.

What Is the t:slim G4 Combo Gimmick?

And then here's a look at what this parvenue t:slim down G4 has to propose:

  • Basics: The pump holds 300 units of insulin housed in a uncomparable micro-delivery infusion and "cartridge bag" scheme. Red-hot color touchscreen. Rechargeable battery, and many of the long-standing insulin pump functions and features.
  • Juvenility: Approved for ages 12 and older, although In tandem hopes the FDA wish lower that maturat to 6 or 7 inside the close twelvemonth. Of line, doctors are able to order this off-label to younger kids if they choose. (For comparison, the Animas Vibe with G4 is sanctioned for ages 18+ while the Medtronic Paradigm Make merry with its Sof-sensor can be used at any age, and the Minimed 530G with Enlite sensing element is for 16+).
  • New Features : Aside from the new CGM integration, this combo device will have newer software than the first-generation t:slims, and will include the new features added in April 2015. Few of those key improvements let in:
  1. Correction Bolus – Users will now be offered the option to reduce their bolus total when a BG entered is below their target area, but above 70 mg/dL. A decrease is still forced when BG is below 70 mg/dL.
  2. Bolus Workflow – Users can now enter a manual bolus directly in the suggested bolus window without first entering a carb value.
  3. Fill Estimate – The pump testament now display an estimated fill amount (indicated by a "+") until 10 units have been pumped, at which target a more than specific volume will be displayed.
  4. Change Pickup/Fill Tubing – Users can now meet their cartridge prior to installing IT along the pump. Additionally, the tubing fill in prison term has been remittent, and there is an audible tone during tubing fill to help prevent inadvertent fill.
  5. Pump History – now includes Total Unit of time Dose values for individual years broken down into units and per centum.
  6. Alerts – The alarm and reminder tones have been increased with multiple frequencies.
  7. Status Screen – Users can now view the Status Screen without unlocking their heart.
  • New Improved t:connect: This is In tandem's prevalent Mac and Personal computer-compatible software, which wish now be expanded to include information from the t:melt off G4. When a CGM-enabled Tandem ticker is linked to a t:connect account, a new CGM hourly report will be gettable to summarize CGM readings. t:svelte G4 customers will have access to wholly existing t:connect content also atomic number 3 this new report, additional logbook stats, and a CGM summary dashboard.
  • Availability: Tandem is taking orders now and pumps bequeath start shipping in October. Merely no access overseas, as Tandem says information technology will be focused on U.S. commercialization for the foreseeable future. ***UPDATE:*** Tandem announced it would start merchant marine this t:slim G4 happening Sept. 23, 2015.
  • Cost: Pre-insurance retail list price is $7295. And that doesn't include the $599 for the G4 vector plus $299 for each box of G4 sensors, sold separately by Dexcom.
  • Reimbursement: Tandem says the pump component of the t:slim G4 should have the same insurance reimbursement as the t:reduce pump and YIMV (Your Policy May Vary).
  • Exchange Offer: Earlier this year, Tandem bicycle irked many in the D-Community with a No-Upgrade insurance. But nowadays it's restricted that stance with an commute insurance: if you've bought a t:svelte Beaver State t:flex along or subsequently Aug. 1, 2015, you'll be able to go a no-be switch to the t:lose weight G4 jazz band. If that's something you'atomic number 75 interested in, you have until Oct. 2 to apply. But in that location's a caution… (read on).
  • Future Upgrades: Tandem is speaking to the Food and Drug Administration approximately its so-called Project Odyssey, which it hopes to file with the agency by year's end to allow chew-in, at-home upgrades of t:slim engineering science and software — similar to updating your smartphone from home. The design is that in the near futurity, In tandem customers will live able to simply connect their t:slims for system updates, including the Bluetooth chip inside that could allow for compatibility with the Bluetooth-enabled Dexcom G5 Ambulatory that's latterly FDA approved. Just customers who upgrade to the t:slim G4 version today will be acquiring a system that doesn't make that capability, since it's connected to the G4 detector using an older wireless signal… This might be a reason to wait connected upgrading to the t:slim G4.

To clarify, neither the t:slim G4 nor G4-integrated Animas Vibe is well-matched with the new G5, nor do they let in the latest G4 advanced algorithm.

You behind actually play around with the t:slender G4 using the very cool t:simulator app that Tandem Diabetes has for both iOS and Android devices. We chequered it out following the approval news, and thought the pump-CGM twist really does look to constitute intuitively-designed (assuming the demo reflects how the gimmick will be in real world).

Predicting the Pump-CGM Future

We asked Tandem spokesman Steve Sabicer about the potential impact of the Dexcom G5 approval on those weighing this new gimmick.

"Decently now the t:lean G4 ticker offers the most accurate pump-integrated CGM available. We think the favorable reception of the G5 adds a great option for people with diabetes who want more flexibility with their CGM access with fewer devices. Instantly people have choices and tail end determine if they prefer to see their information connected their pump or their phone," Sabicer says, noting that the t:slim G4 uses Dexcom's older proprietary antenna so it's in reality a different pump than the t:slim and t:flex that have dormant Bluetooth capability built in.

As to future upgrades through its still-uncertain Externalise Odyssey, Sabicer says this:

"The initial plan for Odyssey is to allow newfangled t:slim customers to update their pumps to the newer software that started merchant vessels in April 2015. We plan to submit this for review to the FDA by the oddment of this year. We are investigating the possible of remotely updating existing t:slim pump software to enable communication with Bluetooth-enabled CGM systems, however IT is too early at this point to speculate on whether this will be feasible. The current t:slim model is a 510k product, and every last CGM-enabled pumps are PMA products."

The difference there being that 510(k) submissions are only required to demonstrate that a gimmick is "substantially equivalent" to a predicate device (single that has been cleared by the FDA operating room marketed earlier 1976), whereas PMA (Pre-Commercialize Approving) submissions call for proof that a rising or altered gimmick is safe and effective, so the standard is higher for receiving clearance.

Soh, while nothing is 100% sure yet, there's a chance that if you have a t:slim or t:turn pump, you might soon have the ability to remotely update your device from home for newer software, and possibly CGM integration connected the screen. Hmmm. A lot to think around.

We can't imagine how difficult this must be for Tandem, reconciliation the forces of business patc trying to best protect and serve patients with existing tech. all spell non knowing what the immediate future holds. This makes for an incredibly challenging position… indefinite that's probably departure to make some populate mad no matter how they decide to proceed.

We feel for you, Tandem. The timing, in large part because of how quickly diabetes device tech and racy wellness has started moving in the past 2 years, has pose you in a tough spot.

Obviously, it's high to each individual customer to resolve for themselves based on cost and their own diabetes management needs. These are just several important considerations we would want to know about, if we were considering the Bicycle-built-for-two devices right now.

Still, as Tandem says, information technology's other great pick for those WHO require and need IT. And we have to applaud that.