PMID- 34270335
OWN - NLM
STAT- MEDLINE
DCOM- 20220328
LR  - 20220401
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 23
IP  - 12
DP  - 2021 Dec
TI  - Ultrarapid Lispro Demonstrates Similar Time in Target Range to Lispro with a 
      Hybrid Closed-Loop System.
PG  - 828-836
LID - 10.1089/dia.2021.0184 [doi]
AB  - Background: Automated insulin delivery systems are associated with improved 
      glycemic outcomes for patients with diabetes. Ultrarapid lispro (URLi), which has 
      an accelerated pharmacokinetic profile and shows superior postprandial glucose 
      control compared to lispro (Humalog((R))), is a potential candidate for use in 
      these systems. Methods: In this double-blind, crossover trial over two 4-week 
      treatment periods, we evaluated URLi in a hybrid closed-loop system using the 
      Medtronic MiniMed 670G system (670G). After a 2-week lead-in on lispro, 42 
      adults with type 1 diabetes were randomized to 1 of 2 treatment sequences of URLi 
      and lispro delivered via the 670G. Primary endpoint was the percentage of time 
      with glucose values within target range 3.9-10.0 mmol/L (70-180 mg/dL; %TIR). 
      Results: Both treatments achieved %TIR over the 24-h period that was above the 
      70% minimum recommended by the International Consensus Guidance: URLi, 77.0%; 
      lispro, 77.8%; P = 0.339. %Time <3.0 mmol/L (54 mg/dL) was similar between 
      treatments (URLi, 0.3%; lispro, 0.4%; P = 0.548) and %time <3.9 mmol/L (70 mg/dL) 
      was lower with URLi (1.5%) versus lispro (2.2%); P = 0.009, while %time 
      >10.0 mmol/L (180 mg/dL) was higher with URLi (21.5% [309.4 min] vs. 19.9% 
      [287.2 min]; P = 0.088). Mean sensor glucose was significantly higher with URLi 
      versus lispro with least squares mean difference of 0.17 mmol/L or 3.0 mg/dL 
      (P = 0.011) between treatments. Insulin dose, %time in Auto Mode per week, and 
      pump settings were similar between treatments. No serious adverse events (AEs) 
      (including severe hypoglycemia) or discontinuations occurred, and the incidence 
      of treatment-emergent AEs was similar between treatments. Although the overall 
      incidence and rate of unplanned infusion set changes were similar between 
      treatments, a significantly higher rate of unplanned infusion set changes due to 
      infusion site reactions was seen during URLi treatment compared with lispro: 0.12 
      versus 0.00 events/30 days (P = 0.063). Conclusions: URLi demonstrated good 
      glycemic control that was comparable to lispro and showed a similar safety 
      profile to lispro with the 670G hybrid closed-loop system. Trial registration: 
      ClinicalTrials.gov, NCT03760640.
FAU - Bode, Bruce
AU  - Bode B
AD  - Atlanta Diabetes Associates, Atlanta, Georgia, USA.
FAU - Carlson, Anders
AU  - Carlson A
AD  - International Diabetes Center, Minneapolis, Minnesota, USA.
FAU - Liu, Rong
AU  - Liu R
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
FAU - Hardy, Thomas
AU  - Hardy T
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
FAU - Bergenstal, Richard
AU  - Bergenstal R
AD  - International Diabetes Center, Minneapolis, Minnesota, USA.
FAU - Boyd, Jennifer
AU  - Boyd J
AD  - Atlanta Diabetes Associates, Atlanta, Georgia, USA.
FAU - Morrett, Scott
AU  - Morrett S
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
FAU - Ignaut, Debra
AU  - Ignaut D
AUID- ORCID: 0000-0002-0449-9393
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03760640
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211026
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Insulin Lispro)
SB  - IM
MH  - Adult
MH  - Blood Glucose
MH  - Cross-Over Studies
MH  - *Diabetes Mellitus, Type 1/drug therapy
MH  - Humans
MH  - *Hypoglycemic Agents
MH  - Insulin/therapeutic use
MH  - Insulin Infusion Systems
MH  - Insulin Lispro
OTO - NOTNLM
OT  - Hybrid closed-loop
OT  - Time in range
OT  - Ultrarapid lispro
EDAT- 2021/07/17 06:00
MHDA- 2022/03/29 06:00
CRDT- 2021/07/16 17:23
PHST- 2021/07/17 06:00 [pubmed]
PHST- 2022/03/29 06:00 [medline]
PHST- 2021/07/16 17:23 [entrez]
AID - 10.1089/dia.2021.0184 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2021 Dec;23(12):828-836. doi: 10.1089/dia.2021.0184. Epub 
      2021 Oct 26.