Memorandum

FDA approves Medtronic’s MiniMed 770G as the first AID system available for 2-6-year-olds in the US – September 1, 2020

Executive Highlights

  • This morning, Medtronic announced FDA approval for Medtronic’s MiniMed 770G, making it the first AID system available for 2-6-year-old patients in the US. Medtronic will begin taking MiniMed 770G orders “this week” and expects to begin shipping “later in the fall.”

  • The MiniMed 770G system consists of the MiniMed 700G series hardware (i.e., the pump for 780G; submitted for FDA review in 3Q19) and the same algorithm as the MiniMed 670G system (SmartGuard Auto Mode). Most notably, the 700G series pump adds Bluetooth connectivity compared to the 600G series pump. MiniMed 770G also includes Guardian Sensor 3 CGM, Roche Accu-Chek Guide Link BGM (because Guardian Sensor 3 is an adjunctive CGM), and the MiniMed smartphone app for secondary display, remote monitoring, and data uploading (see more on this below).

  • MiniMed 770G was submitted to the FDA as a class III system through a PMA submission. In other words, the system is not interoperable. Given the 2019 announcement that Medtronic would partner with Tidepool, we continue to wonder when Medtronic will submit an interoperable AID system (iCGM, ACE pump, and iController algorithm) to the FDA.

  • As a reminder, those who purchase the MiniMed 770G system will be able to upgrade to the 780G algorithm for free when the 780G algorithm is launched. The step-wise approach to MiniMed 780G in the US may help simplify regulatory work somewhat and temporarily stem user migration from MiniMed 670G to competitors’ offerings, but we have to wonder whether patients will take Medtronic up on this offer. Last we heard in May, the MiniMed 780G system and algorithm will launch in the US “later this fiscal year” (FY21 ends in April 2021). Per our conversation with Medtronic today, this 770G FDA approval clears the way for a MiniMed 780G FDA submission soon.

In exciting news for the diabetes community, the FDA and Medtronic both announced FDA approval for Medtronic’s MiniMed 770G, making it the first AID system available for 2-6-year-old patients in the US – a huge win for pediatric patients! Per Medtronic’s announcement, Medtronic will begin taking MiniMed 770G orders “this week” and expects to begin shipping “later in the fall.” The MiniMed 770G system consists of the MiniMed 700G series hardware (i.e., the pump for 780G; submitted for FDA review in 3Q19) and the same algorithm as the MiniMed 670G system (SmartGuard Auto Mode). Most notably, the 700G series pump adds Bluetooth connectivity compared to the 600G series pump. MiniMed 770G also includes Guardian Sensor 3 CGM, Roche Accu-Chek Guide Link BGM (because Guardian Sensor 3 is an adjunctive CGM), and the MiniMed smartphone app for secondary display, remote monitoring, and data uploading (see more on this below). This means that the MiniMed 770G system offers adjusted basal rates every five minutes (like MiniMed 670G), but not automatic correction boluses, reduced alarms, or an adjustable target down to 100 mg/dl (like MiniMed 780G). While this is an exciting AID advancement for Medtronic in the US, we see the algorithm with its automatic correction boluses as the key differentiator between the 670G and the 780G rather than the hardware, meaning that the better advancement will come with the approval and launch of MiniMed 780G in the US. As a reminder, MiniMed 770G users will be able to upgrade to 780G for free when launched.

Slide taken from Medtronic’s ADA 2020 Analyst Day

Clinical Data

  • A ~3-month study of the MiniMed 670G system with 2- to 6-year-olds (n=46; read out at ATTD 2019) showed improvements in Time in Range and A1c and was used to support the submission of MiniMed 770G. Researchers assessed Time in Range and A1c during two weeks in Manual Mode and three months in SmartGuard Auto Mode (the 670G algorithm) in both at-home and hotel phases. They found that the MiniMed 670G algorithm reduced A1c by 0.5% from a baseline of 8.0% and increased Time in Range from 55% to 64% (+2 hours/day), improvements that are comparable to those from the adult 670G pivotal (n=124) and the older pediatric pivotal (7-13 years, n=105). There was no change in time spent in hypoglycemia (<70 mg/dl, ~50 minutes/day), and the researchers recorded no episodes of severe hypoglycemia or DKA nor any serious device-related adverse episodes. Notably, as part of the FDA’s approval, Medtronic has to conduct a real-world study of MiniMed 770G in 2-6-year-olds after the system is released to market. Medtronic has shared several sets of real-world data on MiniMed 670G in adults over the past few years (see ATTD 2020, May 2019, ATTD 2019) and we’re hopeful the real-world data for 770G in young patients will continue to be shared.

Further System Details

  • Bluetooth connectivity is arguably the major upgrade that comes with the MiniMed 770G system. Adding Bluetooth to the pump “gives Medtronic the ability to provide upgrades to future technologies via software updates which can further enhance security and device features,” allowing for at-home software upgrades like those offered by Tandem’s Control-IQ. Bluetooth connectivity will also be important for those who elect to use MiniMed 770G and want the free upgrade to MiniMed 780G’s algorithm when that launches.

    • With Bluetooth connectivity, Medtronic will also launch a MiniMed Mobile app for secondary display, remote monitoring, and data uploading. The app will allow caregivers and care partners to remotely access a user’s CGM and insulin data and will offer proactive in-app alerts when blood glucose levels are out of range. Also through the app, CGM and pump data are easily sharable with clinicians and educators, which, in the era of COVID-19 and telehealth, is an important feature for all people with diabetes. The app is yet to launch, but according to Medtronic, it will be available when MiniMed 770G shipping begins.

  • MiniMed 770G was submitted to the FDA as a class III system through a PMA submission. In other words, the system is not interoperable. As a reminder, interoperable ACE pumps include Tandem’s t:slim X2 (Feb 2019) and Insulet’s Omnipod Dash (Sept 2019), and Control-IQ became the first “Interoperable Automated Glycemic Controller” (iController) approved by the FDA in December 2019, creating a lower-risk class II 510(k) path for AID algorithms. Given the 2019 announcement that Medtronic would partner with Tidepool, we continue to wonder when Medtronic will submit an interoperable AID system (iCGM, ACE pump, and iController algorithm) to the FDA.

  • There were no updates on non-adjunctive indication for the Guardian Sensor 3, which was submitted to the FDA over a year ago. We continue to believe that non-adjunctive indication will be required for MiniMed 780G’s automatic correction bolus feature and for 770G, users will continue to be required to perform a confirmatory fingerstick before making insulin dosing decisions.

  • While 770G is approved for ages 2+, the FDA approval includes a minimum and maximum daily insulin dose required for use: “WARNING: Do not use the SmartGuard™ Auto Mode for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in SmartGuard™ Auto Mode.” Given an average two-year-old weighs ~12.5 kg and typical recommended starting daily doses of insulin range from 0.2 U/kg to 0.8/kg (Lemieux et al., 2010), an average two-year-old type 1 might use 2.5 units - 10 units of insulin per day. We’d imagine for total daily doses less than 8 U, the MiniMed 770G system might run into a host of issues from pumping accuracy to the infusion set to the basal rate automation.

Pathway to MiniMed 780G

  • As a reminder, those who purchase the MiniMed 770G system will be able to upgrade to the 780G algorithm for free when the 780G algorithm is launched. The step-wise approach to MiniMed 780G in the US may help simplify regulatory work somewhat and temporarily stem user migration from MiniMed 670G to competitors’ offerings, and we wonder whether patients will take Medtronic up on this offer. Will patients be willing to start on the MiniMed 770G system and wait for MiniMed 780G to become available hopefully within ~6 months? Or, will patients choose Tandem’s Control-IQ which is already available in the US and offers automated correction boluses, no-fingersticks CGM (Dexcom G6), a free home software update, and embedded Bluetooth?

  • Last we heard in May, the MiniMed 780G system and algorithm will launch in the US “later this fiscal year” (FY21 ends in April 2021). Per our conversation with Medtronic today, this 770G FDA approval clears the way for a MiniMed 780G FDA submission soon. As always, “the timeline for [780G] approval will be dependent on regulatory review.” While the ~3.5 month, single-arm (n=175) US adult pivotal trial was read out at ADA in June, the US pediatric pivotal trial (ClinicalTrials.gov page) continues to be delayed and now aims for a September 30, 2020 primary completion date with the full study completion date set for January 2021, a further delay from 1Q20 expectations for primary completion in August. This delay is particularly notable because that sets back the timeline for pediatric patients using MiniMed 770G who want to upgrade to MiniMed 780G when it is indicated for pediatric use.

Close Concerns’ Questions

  • When will Medtronic begin to ship MiniMed 770G? Are manufacturing capabilities already set to meet order demand?

  • What kind of coverage is available for MiniMed 770G? The same as MiniMed 670G?

    • A: Medtronic is actively engaging with the payer community to enable patient access. More information on payer coverage will be shared when the system is broadly released closer to commercial launch.

  • Will MiniMed 780G be submitted to the FDA as an interoperable iController algorithm? If not, will they wait for the next MiniMed upgrade to submit an interoperable system?

  • When should we expect to see the pediatric pivotal data for MiniMed 780G? What is the timeline for a pediatric MiniMed 780G indication?

 

--by Katie Mahoney, Albert Cai, and Kelly Close