The Medtronic MiniMed™ 670G hybrid closed-loop system with SmartGuard™ technology was released for commercial use in the U.S. in March 2017. Sensor glucose (SG) and device utilization data from the initial open-loop Manual Mode and closed-loop Auto Mode periods were analyzed for the first 1052 patients and compared to those from the MiniMed™ 670G system pivotal trial1.

De-identified data voluntarily uploaded to CareLink™ Personal software, from 3/17/17 to 11/11/17, were evaluated monthly, for 3 months. Data for 12,758 patient-days in Manual Mode and 142,065 patient-days after Auto Mode start were compared to results of the MiniMed™ 670G pivotal trial (124 patients aged 14-75 years) conducted from 6/2/15 to 3/7/16.

The percentage of time in Auto Mode, after initiation, was >85% over the 3 months for the entire commercial cohort. The SG values across glucose ranges were comparable to pivotal trial data (Table).

These findings indicate that outcomes data for the first 1052 patients using the commercial MiniMed™ 670G system mirrored the pivotal trial outcomes. Further, the increased time in target range and decreased hypoglycemia and hyperglycemia were sustained over 3 months.

       
 Pivotal Trial Commercial Launch 
 Manual Mode Auto Mode Manual Mode Auto Mode Month 1 Auto Mode Month 2 Auto Mode Month 3 
Patients, N 124 124 1052 1052 1052 1052 
Auto Mode Use, % - 87.20 - 88.60 86.78 85.96 
Mean SG, mg/dL 150.2 150.78 157.02 149.84 150.30 150.75 
Percentage of time in SG range, mg/dL 
<50 0.85 0.52 0.38 0.30 0.32 0.33 
<54 1.33 0.78 0.60 0.46 0.50 0.52 
<70 5.47 2.95 2.65 2.07 2.21 2.23 
70-180 67.13 72.61 67.39 75.00 74.36 74.07 
>180 27.4 24.45 29.96 22.93 23.43 23.70 
>250 6.94 5.58 7.49 4.50 4.86 5.14 
       
 Pivotal Trial Commercial Launch 
 Manual Mode Auto Mode Manual Mode Auto Mode Month 1 Auto Mode Month 2 Auto Mode Month 3 
Patients, N 124 124 1052 1052 1052 1052 
Auto Mode Use, % - 87.20 - 88.60 86.78 85.96 
Mean SG, mg/dL 150.2 150.78 157.02 149.84 150.30 150.75 
Percentage of time in SG range, mg/dL 
<50 0.85 0.52 0.38 0.30 0.32 0.33 
<54 1.33 0.78 0.60 0.46 0.50 0.52 
<70 5.47 2.95 2.65 2.07 2.21 2.23 
70-180 67.13 72.61 67.39 75.00 74.36 74.07 
>180 27.4 24.45 29.96 22.93 23.43 23.70 
>250 6.94 5.58 7.49 4.50 4.86 5.14 
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1. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes.

Diabetes Technol Ther. 2017;19:155-163.

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.

© 2018 by the American Diabetes Association.
2018
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