Notice: Users may be experiencing issues with displaying some pages on stanfordhealthcare.org. We are working closely with our technical teams to resolve the issue as quickly as possible. Thank you for your patience.
 

Learn about the flu shot, COVID-19 vaccine, and our masking policy »

Stanford Health Care

Glycemic outcomes during early use of the MiniMed 780G advanced hybrid closed-loop system with Guardian 4 sensor. Diabetes technology & therapeutics Cordero, T. L., Dai, Z., Arrieta, A., Niu, F., Vella, M., Shin, J., Rhinehart, A. S., McVean, J., Lee, S., Slover, R. H., Forlenza, G. P., Shulman, D. I., Pop-Busui, R., Thasher, J. R., Kipnes, M. S., Christiansen, M., Buckingham, B. A., Pihoker, C., Sherr, J. L., Kaiserman, K. B., Vigersky, R. A. 2023

Abstract

BACKGROUND: Safety and significant improvement in overall A1C and the percentage of time spent in (TIR), below (TBR) and above (TAR) glucose range were demonstrated in the pivotal trial of adolescents and adults using the MiniMed advanced hybrid closed-loop (AHCL) system with the adjunctive, calibration-required Guardian sensor 3. The present study evaluated early outcomes of continued access study (CAS) participants who transitioned from the pivotal trial investigational system to the approved MiniMed 780G system with the non-adjunctive, calibration-free Guardian 4 sensor (MM780G+G4S). Study data were presented alongside those of real-world MM780G+G4S users from Europe, the Middle East and Africa.METHODS: The CAS participants (N=109, aged 7-17 years and N=67, aged >17 years) used the MM780G+G4S for three months and data of real-world MM780G+G4S system users (N=10,204 aged =15 years and N=26,099 aged >15 years) were uploaded from September 22, 2021 to December 02, 2022. At least 10 days of continuous glucose monitoring (CGM) data were required for analyses. Glycemic metrics, delivered insulin and system use/interactions underwent descriptive analyses.RESULTS: Time in AHCL and CGM use were >90% for all groups. AHCL exits averaged 0.1/day and there were few blood glucose measurements (BGMs) (0.8/day-1.0/day). Adults in both cohorts met most consensus recommendations for glycemic targets. Pediatric groups met recommendations for %TIR and %TBR, albeit not those for mean glucose variability and %TAR, possibly due to low use of recommended glucose target (100 mg/dL) and active insulin time (2 hours) settings (28.4% in the CAS cohort and 9.4% in the real-world cohort). The CAS pediatric and adult A1C were 7.2±0.7% and 6.8±0.7%, respectively, and there were no serious adverse events.CONCLUSIONS: Early clinical use of the MM780G+G4S was safe and involved minimal BGMs and AHCL exits. Similar to real-world pediatric and adult use, outcomes were associated with achievement of target glycemic outcomes.

View details for DOI 10.1089/dia.2023.0123

View details for PubMedID 37252734