Revital Nimri1, Benyamin Grosman2, Anirban Roy2, Judith Nir1, Naama Fisch Shvalb1, Natali Kurtz2, Neta Loewenthal3,4, Michal Gillon-Keren1, Ido Muller5, Eran Atlas5, Moshe Phillip1,6. 1. The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. 2. Medtronic Diabetes, Northridge, California, USA. 3. Pediatric Endocrinology Unit, Soroka University Medical Center, Beer Sheva, Israel. 4. Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel. 5. DreaMed Diabetes Ltd., Petah Tikvah, Israel. 6. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Abstract
Background: The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, which includes several algorithm enhancements and an optional autocorrection bolus mode. Methods: Twelve adolescents and young adults (eight females) with type 1 diabetes [median (interquartile range)] aged 16.6 (15.9, 18.2) years and diabetes duration of 7.1 (4.7, 8.8) years] participated in this single-arm study. The first stage was a 6-day open-loop run-in period, with the predictive low-glucose suspend feature on. This was followed by 6 days/5 nights in a supervised hotel setting, using the AHCL system, including closed-loop challenges (missed meal bolus, late meal bolus, and physical activity); and finally, 3 weeks with unrestricted home use. Glycemic parameters were compared between the open-loop and closed-loop periods. Results: Participants spent 93.3% (4.7) of the time in SmartGuard™ Auto Mode. Hemoglobin A1C levels decreased from median (interquartile range) 7.1% (6.7, 7.9) at baseline to 6.8% (6.6, 7.4) at study end, after 4 weeks (P = 0.0027). Time in range (TIR) (70-180 mg/dL) was 68.4% (10.6) and time below 70 mg/dL was 4% (3.5) during open-loop; and 74% (6.1) and 2.6% (1.9), respectively, during the closed-loop at home phase (P = 0.06, P = 0.27). TIR increased during the nighttime, from 64.6% (17.4) to 80.7% (7.8), P = 0.007, without change in time below 70 mg/dL (P = 0.15). No serious adverse events occurred. Conclusions: The new AHCL system demonstrated safety and effectiveness in controlling day and night glucose levels.
Background: The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, which includes several algorithm enhancements and an optional autocorrection bolus mode. Methods: Twelve adolescents and young adults (eight females) with type 1 diabetes [median (interquartile range)] aged 16.6 (15.9, 18.2) years and diabetes duration of 7.1 (4.7, 8.8) years] participated in this single-arm study. The first stage was a 6-day open-loop run-in period, with the predictive low-glucose suspend feature on. This was followed by 6 days/5 nights in a supervised hotel setting, using the AHCL system, including closed-loop challenges (missed meal bolus, late meal bolus, and physical activity); and finally, 3 weeks with unrestricted home use. Glycemic parameters were compared between the open-loop and closed-loop periods. Results: Participants spent 93.3% (4.7) of the time in SmartGuard™ Auto Mode. Hemoglobin A1C levels decreased from median (interquartile range) 7.1% (6.7, 7.9) at baseline to 6.8% (6.6, 7.4) at study end, after 4 weeks (P = 0.0027). Time in range (TIR) (70-180 mg/dL) was 68.4% (10.6) and time below 70 mg/dL was 4% (3.5) during open-loop; and 74% (6.1) and 2.6% (1.9), respectively, during the closed-loop at home phase (P = 0.06, P = 0.27). TIR increased during the nighttime, from 64.6% (17.4) to 80.7% (7.8), P = 0.007, without change in time below 70 mg/dL (P = 0.15). No serious adverse events occurred. Conclusions: The new AHCL system demonstrated safety and effectiveness in controlling day and night glucose levels.
Authors: Anders L Carlson; Jennifer L Sherr; Dorothy I Shulman; Satish K Garg; Rodica Pop-Busui; Bruce W Bode; David R Lilenquist; Ron L Brazg; Kevin B Kaiserman; Mark S Kipnes; James R Thrasher; John H Chip Reed; Robert H Slover; Athena Philis-Tsimikas; Mark Christiansen; Benyamin Grosman; Anirban Roy; Melissa Vella; Richard A M Jonkers; Xiaoxiao Chen; John Shin; Toni L Cordero; Scott W Lee; Andrew S Rhinehart; Robert A Vigersky Journal: Diabetes Technol Ther Date: 2021-11-16 Impact factor: 6.118