title: Hybrid Closed-Loop Insulin Delivery in Type 1 Diabetes During Supervised Outpatient Conditions.
abstract: Efficacy and safety of the Medtronic Hybrid Closed-Loop (HCL) system were tested in subjects with type 1 diabetes in a supervised outpatient setting.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA benyamin.grosman@medtronic.com.
authors.forename: Benyamin
authors.initials: B
authors.lastname: Grosman
authors.affiliation: Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
authors.forename: Jacob
authors.initials: J
authors.lastname: Ilany
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA.
authors.forename: Anirban
authors.initials: A
authors.lastname: Roy
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA.
authors.forename: Natalie
authors.initials: N
authors.lastname: Kurtz
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA.
authors.forename: Di
authors.initials: D
authors.lastname: Wu
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA.
authors.forename: Neha
authors.initials: N
authors.lastname: Parikh
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA.
authors.forename: Gayane
authors.initials: G
authors.lastname: Voskanyan
authors.affiliation: Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
authors.forename: Noa
authors.initials: N
authors.lastname: Konvalina
authors.affiliation: Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
authors.forename: Chrystaleni
authors.initials: C
authors.lastname: Mylonas
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Gottlieb
authors.affiliation: Medtronic MiniMed, Northridge, CA, USA.
authors.forename: Francine
authors.initials: F
authors.lastname: Kaufman
authors.affiliation: Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
authors.forename: Ohad
authors.initials: O
authors.lastname: Cohen
mesh_terms: D000328:Adult; D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D040421:Cell Phone; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000008:administration & dosage; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D019397:Pancreas, Artificial; D017216:Telemedicine
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: artificial pancreas; diabetes; human trials; insulin pump therapy