Brief Therapeutic Update from PES Drugs and Therapeutics Committee
The MiniMed™780G System
The MiniMed 780G System from Medtronic was approved by the US Food and Drug Administration on April 21, 2023 for use in patients seven years and older with type 1 diabetes.1 The FDA approval comes from the results of the US pivotal trial by Medtronic which included 157 participants, ages 14-75 years.2 The results of the trial showed an increased time in range (TIR) (75% between 70-180mg/dL) with overall time below range of 1.8%. The comparison was the run-in period when participants were able to use the system as a sensor-augmented pump with automated basal delivery (Auto Basal), but not automated insulin correction bolus. No episodes of severe hypoglycemia or DKA were reported in either phase of the study.2 Similar results were seen in the real-world experience across Europe, where the system has been approved since 2020.3 Further, in a recently published retrospective real-world study of 22 adolescents (median age 13.9 [IQR 11,18] years) with a median follow-up of 10.9 (QR 5.4, 17.4) months TIR increased from 65% to 75% (p=0.008).4 In a cohort of children age 2-6 years, there was no difference in time below range over a 12-week period, but increased TIR (+8.3% [9.3], P < 0.001), reduced time above range (-8.6% [9.5], P < 0.001) and reduced parental diabetes distress were observed.5
The MiniMed 780G is an automated insulin delivery system (“hybrid closed loop”) that integrates with the new Guardian 4 sensor, which sends blood glucose levels every 5 minutes and requires one calibration after a 2-hour warm up. Acetaminophen can cause this sensor to have false elevations. The SmartGuard algorithm uses current blood glucose and blood glucose trend to adjust insulin delivery every 5 minutes via auto-basal dosing and auto-corrections. The blood glucose target default is 120 mg/dL; the target can also be set to 110 mg/dL or 100 mg/dL, which is the lowest target glucose of any system currently on the market. The system has a meal detection feature to deliver a stronger correction dose if the system detects a meal based on the rate of increase in sensor glucose level. Medtronic recommends the following settings: For adults, SmartGuard target 100 mg/dL, active insulin time 2 hours; for age 15 and under, SmartGuard target 110 mg/dL and reduce to 100 mg/dL if no hypoglycemia, active insulin time 2 hours. Medtronic has both a 3-day infusion site and a 7-day infusion site.
The Minimed Mobile app is compatible with both Apple and Android smartphones and continues to allow family members to connect through the CareLink Connect App (see https://www.medtronicdiabetes.com/customer-support/app-support/device-compatibility for device compatibility).
Current MiniMed 770G users can upgrade for no additional cost through a remote software update. Other MiniMed insulin pump users may have associated fees with upgrade, but Medtronic does offer a $500 trade in credit toward 780G. The 780G system is enabled for remote software updates.
- FDA Roundup: April 21, 2023 – https://www.fda.gov/news-events/press-announcements/fda-roundup-april-21-2023
- Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Mar;24(3):178-189. doi: 10.1089/dia.2021.0319. Epub 2021 Nov 16. PMID: 34694909.
- Silva JD, Lepore G, Battelino T, Arrieta A, Castañeda J, Grossman B, Shin J, Cohen O. Real-World Performance of the MiniMed™ 780G System: First Report of Outcomes from 4120 Users. Diabetes Technol Ther. 2022 Feb;24(2):113-119. doi: 10.1089/dia.2021.0203.
- Rachmiel, M., Lebenthal, Y., Mazor-Aronovitch, K., Brener, A., Levek, N., Jacobi-Polishook, T., Ben Ari, T., Abiri, S., Landau, Z., & Pinhas-Hamiel, O. (2023). MiniMed 780G Advanced Hybrid Closed Loop System Outcomes According to Pubertal Status – Awesome Study Group Real-Life Experience. Diabetes technology & therapeutics, 10.1089/dia.2023.0081. Advance online publication.
- Pulkkinen, M. A., Varimo, T. J., Hakonen, E. T., Harsunen, M. H., Hyvönen, M. E., Janér, J. N., Kiiveri, S. M., Laakkonen, H. M., Laakso, S. M., Wehkalampi, K., Hero, M. T., Miettinen, P. J., & Tuomaala, A. K. (2023). MiniMed 780G™ in 2- to 6-Year-Old Children: Safety and Clinical Outcomes After the First 12 Weeks. Diabetes technology & therapeutics, 25(2), 100–107.
- MiniMed™ Systems Product Specifications; MiniMed™ 780G System Quick Reference Guide, provided by Medtronic, https://www.medtronicdiabetes.com/sites/default/files/library/download-library/user-guides/MiniMed-780G-system-user-guide-with-Guardian-4-sensor.pdf
Prepared on behalf of PES Drugs and Therapeutics Committee by:
Neha Patel, DO