TY - JOUR
T1 - Hybrid Closed-Loop Insulin Delivery in Type 1 Diabetes during Supervised Outpatient Conditions
AU - Grosman, Benyamin
AU - Ilany, Jacob
AU - Roy, Anirban
AU - Kurtz, Natalie
AU - Wu, Di
AU - Parikh, Neha
AU - Voskanyan, Gayane
AU - Konvalina, Noa
AU - Mylonas, Chrystaleni
AU - Gottlieb, Rebecca
AU - Kaufman, Francine
AU - Cohen, Ohad
N1 - Publisher Copyright:
© Diabetes Technology Society.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - Background: Efficacy and safety of the Medtronic Hybrid Closed-Loop (HCL) system were tested in subjects with type 1 diabetes in a supervised outpatient setting. Methods: The HCL system is a prototype research platform that includes a sensor-augmented insulin pump in communication with a control algorithm housed on an Android-based cellular device. Nine subjects with type 1 diabetes (5 female, mean age 53.3 years, mean A1C 7.2%) underwent 9 studies totaling 571 hours of closed-loop control using either default or personalized parameters. The system required meal announcements with estimates of carbohydrate (CHO) intake that were based on metabolic kitchen quantification (MK), dietician estimates (D), or subject estimates (Control). Postprandial glycemia was compared for MK, D, and Control meals. Results: The overall sensor glucose mean was 145 ± 43, the overall percentage time in the range 70-180 mg/dL was 80%, the overall percentage time <70 mg/dL was 0.79%. Compared to intervals of default parameter use (225 hours), intervals of personalized parameter use (346 hours), sensor glucose mean was 158 ± 49 and 137 ± 37 mg/dL (P <.001), respectively, and included more time in range (87% vs 68%) and less time below range (0.54% vs 1.18%). Most subjects underestimated the CHO content of meals, but postprandial glycemia was not significantly different between MK and matched Control meals (P =.16) or between D and matched Control meals (P =.76). There were no episodes of severe hypoglycemia. Conclusions: The HCL system was efficacious and safe during this study. Personally adapted HCL parameters were associated with more time in range and less time below range than default parameters. Accurate estimates of meal CHO did not contribute to improved postprandial glycemia.
AB - Background: Efficacy and safety of the Medtronic Hybrid Closed-Loop (HCL) system were tested in subjects with type 1 diabetes in a supervised outpatient setting. Methods: The HCL system is a prototype research platform that includes a sensor-augmented insulin pump in communication with a control algorithm housed on an Android-based cellular device. Nine subjects with type 1 diabetes (5 female, mean age 53.3 years, mean A1C 7.2%) underwent 9 studies totaling 571 hours of closed-loop control using either default or personalized parameters. The system required meal announcements with estimates of carbohydrate (CHO) intake that were based on metabolic kitchen quantification (MK), dietician estimates (D), or subject estimates (Control). Postprandial glycemia was compared for MK, D, and Control meals. Results: The overall sensor glucose mean was 145 ± 43, the overall percentage time in the range 70-180 mg/dL was 80%, the overall percentage time <70 mg/dL was 0.79%. Compared to intervals of default parameter use (225 hours), intervals of personalized parameter use (346 hours), sensor glucose mean was 158 ± 49 and 137 ± 37 mg/dL (P <.001), respectively, and included more time in range (87% vs 68%) and less time below range (0.54% vs 1.18%). Most subjects underestimated the CHO content of meals, but postprandial glycemia was not significantly different between MK and matched Control meals (P =.16) or between D and matched Control meals (P =.76). There were no episodes of severe hypoglycemia. Conclusions: The HCL system was efficacious and safe during this study. Personally adapted HCL parameters were associated with more time in range and less time below range than default parameters. Accurate estimates of meal CHO did not contribute to improved postprandial glycemia.
KW - artificial pancreas
KW - diabetes
KW - human trials
KW - insulin pump therapy
UR - http://www.scopus.com/inward/record.url?scp=85009513411&partnerID=8YFLogxK
U2 - 10.1177/1932296816631568
DO - 10.1177/1932296816631568
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C2 - 26880389
AN - SCOPUS:85009513411
SN - 1932-2968
VL - 10
SP - 708
EP - 713
JO - Journal of diabetes science and technology
JF - Journal of diabetes science and technology
IS - 3
ER -