PMID- 32940537
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20220531
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 23
IP  - 3
DP  - 2021 Mar
TI  - Performance of an Automated Insulin Delivery System: Results of Early Phase 
      Feasibility Studies.
PG  - 187-194
LID - 10.1089/dia.2020.0318 [doi]
AB  - Background: Automated insulin delivery (AID) systems have demonstrated 
      improvements in time-in-range (TIR, blood glucose 70-180 mg/dL) without 
      increasing hypoglycemia. Testing a closed-loop system in an inpatient environment 
      with supervised challenges allows for initial evaluation of performance and 
      safety of the system. Methods: Adults with type 1 diabetes (T1D) were enrolled 
      into two similar studies (n = 10 per study), with 3-day inpatient analysis 
      periods. Participants tested a Lilly hybrid closed-loop (HCL) system comprising 
      an investigational insulin pump, insulin lispro, a pump-embedded model predictive 
      control algorithm, a continuous glucose monitor (CGM), and an external dedicated 
      controller. Each protocol included meal-related and exercise challenges to 
      simulate real-world diabetes self-management errors. Only study staff interacted 
      with the HCL system. Performance was assessed using standard CGM metrics overall 
      and within prespecified periods. Results: Participants (25% male) had 
      mean +/- standard deviation (SD) age 44.7 +/- 14.2 years, T1D duration 30.2 +/- 11.1 
      years, A1C 7.2% +/- 0.8%, and insulin usage 0.53 +/- 0.21 U/(kg.day). Percentage TIR 
      70-180 mg/dL (mean +/- SD) was 81.2 +/- 8.4 overall, 85.2 +/- 8.1 outside of challenge 
      periods, 97.3 +/- 5.3 during the nocturnal periods, and 74.5 +/- 16.2 for the 
      postprandial periods. During challenge periods, percentage TIR for the overbolus 
      challenge was 65.4 +/- 29.2 and that for the delayed bolus challenge was 
      57.1 +/- 25.1. No adverse events (AEs), serious AEs, or unanticipated adverse 
      device events occurred while participants were using the HCL system. Conclusions: 
      In participants with T1D, Lilly AID system demonstrated expected algorithm 
      performance and safety with satisfactory glycemic outcomes overall and in 
      response to simulated diabetes management challenges. Additional studies in less 
      supervised conditions and with broader patient populations are warranted. 
      ClinicalTrials.gov Registration number NCT03743285, NCT03849612.
FAU - Christiansen, Mark
AU  - Christiansen M
AD  - Diablo Clinical Research, Walnut Creek, California, USA.
FAU - Bartee, Amy
AU  - Bartee A
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Lalonde, Amy
AU  - Lalonde A
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Jones, Richard E
AU  - Jones RE
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Katz, Michelle
AU  - Katz M
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Wolpert, Howard
AU  - Wolpert H
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Brazg, Ronald
AU  - Brazg R
AD  - Ranier Clinical Research Center, Renton, West Virginia, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03849612
SI  - ClinicalTrials.gov/NCT03743285
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20201005
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Adult
MH  - Blood Glucose
MH  - Blood Glucose Self-Monitoring
MH  - *Diabetes Mellitus, Type 1/drug therapy
MH  - Feasibility Studies
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/therapeutic use
MH  - Insulin/administration & dosage/therapeutic use
MH  - *Insulin Infusion Systems
MH  - Male
MH  - Middle Aged
MH  - *Pancreas, Artificial
PMC - PMC7906863
OTO - NOTNLM
OT  - Automated insulin delivery
OT  - Early feasibility
OT  - Hybrid closed loop
COIS- A.B., A.L., R.E.J., M.K., and H.W. are employees and shareholders of Eli Lilly 
      and Company.
EDAT- 2020/09/18 06:00
MHDA- 2021/11/26 06:00
PMCR- 2021/02/25
CRDT- 2020/09/17 12:15
PHST- 2020/09/18 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2020/09/17 12:15 [entrez]
PHST- 2021/02/25 00:00 [pmc-release]
AID - 10.1089/dia.2020.0318 [pii]
AID - 10.1089/dia.2020.0318 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2021 Mar;23(3):187-194. doi: 10.1089/dia.2020.0318. Epub 
      2020 Oct 5.