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Randomized Controlled Trial
. 2022 Aug;24(8):573-582.
doi: 10.1089/dia.2021.0568. Epub 2022 Apr 28.

A Comparison of Postprandial Glucose Control in the Medtronic Advanced Hybrid Closed-Loop System Versus 670G

Stuart A Weinzimer  1 , Ryan J Bailey  2 , Richard M Bergenstal  3 , Revital Nimri  4   5 , Roy W Beck  2 , Desmond Schatz  6 , Louise Ambler-Osborn  7 , Darja Smigoc Schweiger  8   9 , Thekla von dem Berge  10 , Judy Sibayan  2 , Mary L Johnson  3 , Peter Calhoun  2 , Moshe Phillip  4   5 ; FLAIR Study Group
Collaborators, Affiliations
Randomized Controlled Trial

A Comparison of Postprandial Glucose Control in the Medtronic Advanced Hybrid Closed-Loop System Versus 670G

Stuart A Weinzimer et al. Diabetes Technol Ther. 2022 Aug.

Abstract

Background: We recently reported that use of an "advanced" hybrid closed-loop system reduced hyperglycemia without increasing hypoglycemia compared to a first-generation system. The aim of this analysis was to evaluate whether this improved performance was specifically related to better mealtime glycemic control. Methods: We conducted a secondary analysis of postprandial glycemic control in an open-label, multinational, randomized crossover trial of 112 participants with type 1 diabetes, aged 14-29, of the Medtronic MiniMed™ 670G hybrid closed-loop system (670G) versus the Medtronic advanced hybrid closed-loop (AHCL) system, for 12 weeks each. We compared glycemic and insulin delivery metrics over a 3 h horizon across all meals to assess system performance and outcomes. Results: Overall meal size and premeal insulin on board were similar during run-in and between 670G and AHCL arms. Compared with 670G arm, premeal, peak, and mean glucose levels were numerically lower in the AHCL arm (167 ± 23, 231 ± 23, and 177 ± 20 mg/dL vs. 175 ± 23, 235 ± 23, and 180 ± 19 mg/dL, respectively), with a trend to lower hyperglycemia level 2 in AHCL arm. Adjusting for premeal glucose level, all postmeal outcomes between 670G and AHCL were statistically similar. Prandial insulin delivery also was similar in both treatment arms (21 ± 9 vs. 23 ± 10 U), with a shift in basal/bolus ratio from 28%/71% in 670G arm to 20%/80% in AHCL arm. Conclusions: Reduced hyperglycemia with AHCL compared to 670G was not related to early postprandial glycemic excursions after adjusting for premeal glucose level (<3 h after meal), but likely to later (>3 h) postprandial or overnight improvements. Further refinements to mealtime bolus algorithms and strategies may more optimally control prandial glycemic excursions.

Keywords: Adolescents; Closed-loop system; Postprandial blood glucose; Young adults.

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Conflict of interest statement

Medtronic MiniMed, Inc., provided the MiniMed 670G and AHCL systems, and infusion sets, used in the study. Medtronic, Inc.; provided study continuous glucose monitoring devices and sensors. S.A.W. reports grants from the National Institutes of Health, during the conduct of the study; personal fees from Medtronic, Insulet, Tandem, Eli Lilly, Sanofi, and Zealand, outside the submitted work. R.J.B. reports no conflicts of interest. R.M.B. reports grants and other from Abbott Diabetes Care, grants and other from Eli Lilly, outside the submitted work. R.N. reports grants from National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, nonfinancial support from Medtronic MiniMed, Inc., during the conduct of the study; grants, personal fees and other from DreaMed Diabetes Ltd., grants and nonfinancial support from Medtronic MiniMed, Inc., nonfinancial support from Dexcom, nonfinancial support from Insulet, grants, and personal fees from Eli Lilly, grants and personal fees from NovoNordisk, outside the submitted work. R.W.B. reports grants from National Institutes of Health, nonfinancial support from Medtronic during the conduct of the study; grants, nonfinancial support and study supplies from Dexcom, consulting fees paid to nonprofit employer from Bigfoot Biomedical, outside the submitted work. D.S. reports grants from the National Institutes of Health, during the conduct of the study; grants from the Leona M. and Harry B. Helmsley Charitable Trust, outside the submitted work. L.A.-O. reports no conflicts of interest. D.S.S. reports no conflicts of interest. T.v.d.B. reports grants and fees from NovoNordisk, Medtronic, Sanofi and Ypsomed outside the submitted work. J.S. reports no conflicts of interest. M.L.J. reports grants from the National Institutes of Health during the conduct of the study; grants from Abbott, Dexcom, Medtronic, Eli Lilly, NovoNordisk, Calibra, Insulet, Sanofi, the Leona M. and Harry B. Helmsley Charitable Trust,, and the Juvenile Diabetes Research Foundation, outside the submitted work. P.C. reports personal fees from Dexcom outside the submitted work. M.P. reports grants from the National Institutes of Health via Health Partners, during the conduct of the study; grants from Insulet, Dexcom, Medtronic, Roche, Eli Lilly, Lexicon, OPKO, and AstraZeneca, grants and personal fees from Novo Nordisk and Sanofi, grants, personal fees and owning stock from DreaMed Diabetes, personal fees from RSP Systems and Qulab Medical, grants and personal fees from Pfizer, grants and owning stock from Nutriteen Professional and NG Solutions, outside the submitted work. In addition, M.P. has a patent WO2010097796 issued to DreaMed Diabetes, a patent WO2011039741 issued to DraeMed Diabetes, and a patent WO2019077482 pending.

Figures

FIG. 1.
FIG. 1.
Boxplots of peak, time to peak, nadir, and excursion by type of meal and treatment arm.
FIG. 2.
FIG. 2.
Mean glucose by 24 h (top panel) and mean insulin delivery by hour (bottom panel).
See this image and copyright information in PMC

References

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