PMID- 26880389
OWN - NLM
STAT- MEDLINE
DCOM- 20171128
LR  - 20181113
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 10
IP  - 3
DP  - 2016 May
TI  - Hybrid Closed-Loop Insulin Delivery in Type 1 Diabetes During Supervised 
      Outpatient Conditions.
PG  - 708-13
LID - 10.1177/1932296816631568 [doi]
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.
CI  - (c) 2016 Diabetes Technology Society.
FAU - Grosman, Benyamin
AU  - Grosman B
AD  - Medtronic MiniMed, Northridge, CA, USA benyamin.grosman@medtronic.com.
FAU - Ilany, Jacob
AU  - Ilany J
AD  - Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
FAU - Roy, Anirban
AU  - Roy A
AD  - Medtronic MiniMed, Northridge, CA, USA.
FAU - Kurtz, Natalie
AU  - Kurtz N
AD  - Medtronic MiniMed, Northridge, CA, USA.
FAU - Wu, Di
AU  - Wu D
AD  - Medtronic MiniMed, Northridge, CA, USA.
FAU - Parikh, Neha
AU  - Parikh N
AD  - Medtronic MiniMed, Northridge, CA, USA.
FAU - Voskanyan, Gayane
AU  - Voskanyan G
AD  - Medtronic MiniMed, Northridge, CA, USA.
FAU - Konvalina, Noa
AU  - Konvalina N
AD  - Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
FAU - Mylonas, Chrystaleni
AU  - Mylonas C
AD  - Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
FAU - Gottlieb, Rebecca
AU  - Gottlieb R
AD  - Medtronic MiniMed, Northridge, CA, USA.
FAU - Kaufman, Francine
AU  - Kaufman F
AD  - Medtronic MiniMed, Northridge, CA, USA.
FAU - Cohen, Ohad
AU  - Cohen O
AD  - Institute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160503
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Adult
MH  - Algorithms
MH  - Blood Glucose/*analysis
MH  - Blood Glucose Self-Monitoring/*instrumentation
MH  - Cell Phone
MH  - Diabetes Mellitus, Type 1/blood/*drug therapy
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage
MH  - Insulin/administration & dosage
MH  - *Insulin Infusion Systems
MH  - Male
MH  - Middle Aged
MH  - Outpatients
MH  - *Pancreas, Artificial
MH  - Telemedicine
PMC - PMC5038540
OTO - NOTNLM
OT  - artificial pancreas
OT  - diabetes
OT  - human trials
OT  - insulin pump therapy
COIS- The author(s) declared the following potential conflicts of interest with respect 
      to the research, authorship, and/or publication of this article: BG, AR, NK, DW, 
      NP, GV, RG, FK and OC are Medtronic employees.
EDAT- 2016/02/18 06:00
MHDA- 2017/11/29 06:00
PMCR- 2017/02/15
CRDT- 2016/02/17 06:00
PHST- 2016/02/17 06:00 [entrez]
PHST- 2016/02/18 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
PHST- 2017/02/15 00:00 [pmc-release]
AID - 1932296816631568 [pii]
AID - 10.1177_1932296816631568 [pii]
AID - 10.1177/1932296816631568 [doi]
PST - epublish
SO  - J Diabetes Sci Technol. 2016 May 3;10(3):708-13. doi: 10.1177/1932296816631568. 
      Print 2016 May.