Real-World Data from the MiniMed™ 670G System Commercial Launch

Abstract

The Medtronic MiniMed™ 670G hybrid closed-loop system with SmartGuard™ technology, which automatically adjusts basal insulin delivery, was released for commercial use in the U.S. in March 2017. Data from the first 13,9patients to use the system are reported. MiniMed™ 670G data from patients who voluntarily uploaded to CareLink™ Personal software, from 3/17/17 to 12/14/17, were de-identified and analyzed if there were ≥7 days of sensor wear. Comparisons of glycemic metrics between 258,415 patient-days in the initial open-loop Manual Mode and 724,220 patient-days after starting closed-loop Auto Mode were made. Data were compared for patients 7-13 years, 14-21 years, 22-60 years, and ≥60 years. The Table shows glycemic metrics, including time in target range (TIR, 70-180mg/dL), during Manual Mode and after Auto Mode start for all users and by age group. Children and teens had lower baseline TIR and more hyperglycemia in Manual Mode vs. adults, but a similar magnitude of improvement when in Auto Mode. Older adults had the most optimal glycemia with Auto Mode. TIR was higher in patients with greater time in Auto Mode. For those in Auto Mode 50-59% of the time, mean TIR was 65%; for Auto Mode 60-80% of the time, TIR was 68%; and for Auto Mode >80% of the time, TIR was 74%. Overall, data from the commercial launch of the MiniMed™ 670G system mirrored the pivotal trial1 results for all ages and showed an increase in TIR with less hypoglycemia and hyperglycemia. All Patients7-13 years14-21 years22-60 years≥ 60 yearsManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startManual ModeAfter Auto Mode startPatients, N13,906479126293781946Auto Mode Use, %-80.05%-77.58%-66.07%-80.89%-84.95%Mean SG, mg/dL163.53154.87183.44163.44179.55166.98161.50153.55156.91150.38SD SG, mg/dL54.2251.0463.1560.5563.0560.2953.3550.0649.9447.22Percentage of time in SG range, mg/dL<500.38%0.31%0.22%0.25%0.38%0.37%0.41%0.33%0.29%0.22%<540.60%0.49%0.36%0.40%0.59%0.57%0.64%0.51%0.47%0.36%<702.59%2.05%1.71%2.03%2.42%2.21%2.77%2.12%2.21%1.76%70-18063.16%71.35%52.31%64.86%53.49%62.68%64.12%72.13%68.27%75.26%>18034.24%26.60%45.98%33.11%44.09%35.11%33.11%25.75%29.52%22.98%>2509.58%6.18%17.22%10.37%16.49%11.42%8.79%5.53%6.69%4.55%>3003.22%1.86%6.94%3.73%6.57%4.34%2.82%1.53%1.91%1.20% Disclosure P. Agrawal: None. M. Stone: None. S. Gopalakrishnan: Employee; Self; Medtronic. C. Fogel: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.