Memorandum

FDA approves Medtronic MiniMed 670G/Guardian Sensor 3 for pediatrics ages 7-13; Available for immediate shipment! – June 21, 2018

Executive Highlights

  • FDA approved Medtronic’s MiniMed 670G/Guardian Sensor 3 hybrid closed loop system for children ages 7-13 today after a five-month review. It becomes the first hybrid closed loop indicated for pediatric use, 21 months after Medtronic received adult/adolescent approval. Systems are available for immediate shipment!

  • The approval was based off a single-arm, three-month, 105-participant study originally presented at ATTD. The device’s performance strongly resembled that in adults, with a 0.4% reduction in A1c (baseline: 7.9%), a +2 hours/day improvement in time-in-range (71-180 mg/dl), and 24 minutes/day fewer ≤70 mg/dl.

  • Notably, of the first ~14,000 US 670G patients, n=479 were 7-13-year-olds using the system off-label. In the real-world, they were spending 65% time-in-range and ~78% of their day in auto mode. 

  • Hybrid closed loop could see much stronger adoption in pediatrics, given parent anxiety overnight and dramatically-improved sleep for the whole family. The two immediate hurdles to pediatric 670G adoption are: (i) How will parents weigh automated insulin delivery vs. the ability to remote monitor glucose levels (not currently possible with 670G)?; and (ii) The 670G requires a fair amount of user intervention – how difficult is it to train/support pediatrics to use it safely and optimally?

  • The seven-site, n=50, three-month 670G study in children ages 2-6 is still underway. CMO Dr. Fran Kaufman noted in February that the trial was wrapping up, so we wonder if it has hit a snag.

  • Tandem’s Basal.IQ (predictive low glucose suspend) was also approved today for 6+ years, offering competition to 670G in pediatrics. Basal.IQ will work with G6 (no calibration) and will have remote monitoring via the G6 app. 

This afternoon, Medtronic announced that FDA has approved the MiniMed 670G/Guardian Sensor 3 hybrid closed loop system for use in children 7-13 years old after a ~five-month review. 670G is now the first hybrid closed loop available to the pediatric age group – listen to Medtronic global CMO Dr. Fran Kaufman describe the significance of the approval in this ~one-minute video included in the press release.

Systems are available for immediate shipment to the pediatric population, another sign Medtronic appears to have solved the sensor scaling challenges that plagued the adult/adolescent launch. To date, >100,000 670G systems have been shipped, with >70,000 patients trained.

As Dr. Kaufman pointed out in the video, the pivotal study data in ages 7-13 (single-arm, three-months, n=105; originally presented at ATTD) strongly resembled that of the adult/adolescent pivotal: Compared to a two-week open-loop run-in period, 670G drove a 0.4% reduction in A1c in the pediatric population (baseline: 7.9%); time-in-range (71-180 mg/dl) improved from 56% to 65% (a strong +2 hours/day); time <70 mg/dl declined from 4.7% to 3.0% (-24 mins/day); and time >180 mg/dl improved from 39% to 32% (-1.7 hours/day). The A1c endpoint and all CGM metrics were highly statistically significant in favor of the 670G (p<0.001), and there were no DKA, severe hypoglycemia, or serious adverse device-related events reported. This is encouraging data, and this group was doing pretty well at baseline relative to standard of care.

There are already at least a few-hundred children in this age group using 670G off-label. At ATTD, Dr. Fran Kaufman presented real-world 670G data uploaded voluntarily to CareLink from the first 13,906 US patients on the system, 479 of which were ages 7-13. This age group spent 78% of time in auto mode, during which they were in-range 65% and <70 mg/dl only 3% of the time. Assuming the number of pediatrics using 670G off-label has scaled with the total number of 670G users in the US, there could already be >2,000 pediatric users prior to this FDA approval.

For parents, automated insulin delivery will be a bigger gamechanger than it has been for many adults: the return of full nights of sleep, less anxiety at night, throughout the school day, and when the child is with friends or having fun. The reduction in stress could be tremendous! At the same time, we’ve heard time and again that the 670G still requires a fair level of manual involvement and Auto Mode finesse, and it is crucial that adults and children are adequately prepared. In that vein, we’re looking forward to a Barbara Davis poster at ADA outlining a clinical training program for hybrid closed loop in a pediatric clinic.

Another nuance to pediatric adoption is that, as it stands, the 670G doesn’t enable remote monitoring, while Dexcom’s G5/G6 and Tandem’s just-approved Basal.IQ (6+ years) do. How will parents weigh automation vs. the ability to track glucose and be alerted to excursions? Medtronic plans to remedy this hurdle by launching a Bluetooth-enabled 670G pump, which would presumably enable monitoring, within the next two years (by April 2020).

As for the 2-6-year-old cohort, a seven-site, n=50, three-month study is still under way. In February, Dr. Kaufman indicated that the trial was in the process of wrapping up, so we are surprised to hear that it is still underway. Then again, educating and supporting very young children to use a user-intensive system safely can’t be an easy feat. We very much appreciate Medtronic’s focus on (young) human-factors and pushing to get cutting edge technology to the youngest type 1s. 

  • There are at least three other pediatric 670G abstracts at ADA: (i) Clinical Experience with the MiniMed 670G System in Children, Adolescents, and Young Adults with Type 1 Diabetes (84-LB; including 10 kids ages 5-9); (ii) Overnight to Early-Morning Glycemic Outcomes in Children Using the MiniMed 670G Hybrid Closed-Loop System (236-OR); and (iii) Overnight Insulin Delivery and Glucose in Children Using the MiniMed 670G System (206-OR).

 

-- by Brian Levine, Adam Brown, and Kelly Close