PMID- 37578778
OWN - NLM
STAT- MEDLINE
DCOM- 20231031
LR  - 20240316
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 25
IP  - 10
DP  - 2023 Oct
TI  - Automated Insulin Delivery with Remote Real-Time Continuous Glucose Monitoring 
      for Hospitalized Patients with Diabetes: A Multicenter, Single-Arm, Feasibility 
      Trial.
PG  - 677-688
LID - 10.1089/dia.2023.0304 [doi]
AB  - Introduction: Multiple daily injection insulin therapy frequently fails to meet 
      hospital glycemic goals and is prone to hypoglycemia. Automated insulin delivery 
      (AID) with remote glucose monitoring offers a solution to these shortcomings. 
      Research Design and Methods: In a single-arm multicenter pilot trial, we tested 
      the feasibility, safety, and effectiveness of the Omnipod 5 AID System with 
      real-time continuous glucose monitoring (CGM) for up to 10 days in hospitalized 
      patients with insulin-requiring diabetes on nonintensive care unit 
      medical-surgical units. Primary endpoints included the proportion of time in 
      automated mode and percent time-in-range (TIR 70-180 mg/dL) among participants 
      with >48 h of CGM data. Safety endpoints included incidence of severe 
      hypoglycemia and diabetes-related ketoacidosis (DKA). Additional glycemic 
      endpoints, CGM accuracy, and patient satisfaction were also explored. Results: 
      Twenty-two participants were enrolled; 18 used the system for a total of 96 days 
      (mean 5.3 +/- 3.1 days per patient), and 16 had sufficient CGM data required for 
      analysis. Median percent time in automated mode was 95% (interquartile range 
      92%-98%) for the 18 system users, and the 16 participants with >48 h of CGM data 
      achieved an overall TIR of 68% +/- 16%, with 0.17% +/- 0.3% time <70 mg/dL and 
      0.06% +/- 0.2% time <54 mg/dL. Sensor mean glucose was 167 +/- 21 mg/dL. There were 
      no DKA or severe hypoglycemic events. All participants reported satisfaction with 
      the system at study end. Conclusions: The use of AID with a disposable tubeless 
      patch-pump along with remote real-time CGM is feasible in the hospital setting. 
      These results warrant further investigation in randomized trials.
FAU - Davis, Georgia M
AU  - Davis GM
AD  - Division of Endocrinology, Metabolism, and Lipids, Department of Medicine, Emory 
      University School of Medicine, Atlanta, Georgia, USA.
FAU - Hughes, Michael S
AU  - Hughes MS
AUID- ORCID: 0000-0002-3729-0350
AD  - Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, 
      Stanford University, Stanford, California, USA.
FAU - Brown, Sue A
AU  - Brown SA
AD  - Division of Endocrinology, Center for Diabetes Technology, University of 
      Virginia, Charlottesville, Virginia, USA.
FAU - Sibayan, Judy
AU  - Sibayan J
AD  - Jaeb Center for Health Research, Tampa, Florida, USA.
FAU - Perez-Guzman, M Citlalli
AU  - Perez-Guzman MC
AD  - Division of Endocrinology, Metabolism, and Lipids, Department of Medicine, Emory 
      University School of Medicine, Atlanta, Georgia, USA.
FAU - Stumpf, Meaghan
AU  - Stumpf M
AD  - Division of Endocrinology, Center for Diabetes Technology, University of 
      Virginia, Charlottesville, Virginia, USA.
FAU - Thompson, Zachary
AU  - Thompson Z
AD  - Jaeb Center for Health Research, Tampa, Florida, USA.
FAU - Basina, Marina
AU  - Basina M
AD  - Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, 
      Stanford University, Stanford, California, USA.
FAU - Patel, Ronak M
AU  - Patel RM
AD  - Division of Endocrinology, Center for Diabetes Technology, University of 
      Virginia, Charlottesville, Virginia, USA.
FAU - Hester, Joi
AU  - Hester J
AD  - Division of Endocrinology, Metabolism, and Lipids, Department of Medicine, Emory 
      University School of Medicine, Atlanta, Georgia, USA.
FAU - Abraham, Amalia
AU  - Abraham A
AD  - Division of Endocrinology, Metabolism, and Lipids, Department of Medicine, Emory 
      University School of Medicine, Atlanta, Georgia, USA.
FAU - Ly, Trang T
AU  - Ly TT
AUID- ORCID: 0000-0002-5995-1447
AD  - Insulet Corporation, Acton, Massachusetts, USA.
FAU - Chaney, Cherie
AU  - Chaney C
AD  - Division of Endocrinology, Center for Diabetes Technology, University of 
      Virginia, Charlottesville, Virginia, USA.
FAU - Tan, Marilyn
AU  - Tan M
AD  - Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, 
      Stanford University, Stanford, California, USA.
FAU - Hsu, Liana
AU  - Hsu L
AD  - Division of Pediatric Endocrinology, Department of Pediatrics, Stanford 
      University, Stanford, California, USA.
FAU - Kollman, Craig
AU  - Kollman C
AD  - Jaeb Center for Health Research, Tampa, Florida, USA.
FAU - Beck, Roy W
AU  - Beck RW
AUID- ORCID: 0000-0002-5194-8446
AD  - Jaeb Center for Health Research, Tampa, Florida, USA.
FAU - Lal, Rayhan
AU  - Lal R
AUID- ORCID: 0000-0002-8055-944X
AD  - Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, 
      Stanford University, Stanford, California, USA.
AD  - Division of Pediatric Endocrinology, Department of Pediatrics, Stanford 
      University, Stanford, California, USA.
FAU - Buckingham, Bruce
AU  - Buckingham B
AD  - Division of Pediatric Endocrinology, Department of Pediatrics, Stanford 
      University, Stanford, California, USA.
FAU - Pasquel, Francisco J
AU  - Pasquel FJ
AUID- ORCID: 0000-0002-3845-6703
AD  - Division of Endocrinology, Metabolism, and Lipids, Department of Medicine, Emory 
      University School of Medicine, Atlanta, Georgia, USA.
LA  - eng
GR  - K23 GM128221/GM/NIGMS NIH HHS/United States
GR  - K23 DK122017/DK/NIDDK NIH HHS/United States
GR  - T32 DK007217/DK/NIDDK NIH HHS/United States
GR  - K23 DK122199/DK/NIDDK NIH HHS/United States
GR  - P30 DK116074/DK/NIDDK NIH HHS/United States
GR  - K12 DK122550/DK/NIDDK NIH HHS/United States
GR  - P30 DK111024/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20230828
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, Regular, Human)
SB  - IM
MH  - Humans
MH  - Blood Glucose
MH  - Blood Glucose Self-Monitoring/methods
MH  - *Diabetes Mellitus, Type 1/drug therapy
MH  - *Diabetic Ketoacidosis
MH  - Feasibility Studies
MH  - *Hypoglycemia/chemically induced/prevention & control
MH  - Hypoglycemic Agents/therapeutic use
MH  - Insulin/therapeutic use
MH  - Insulin Infusion Systems
MH  - Insulin, Regular, Human/therapeutic use
MH  - Pilot Projects
PMC - PMC10611957
OTO - NOTNLM
OT  - Automated insulin delivery
OT  - Hybrid closed-loop
OT  - Inpatient diabetes
COIS- G.M.D. has received research support (to Emory University) from Insulet and 
      consulting fees from Medscape, and M.S.H. has received consulting fees from 
      Dexcom, Inc. S.A.B. has received research support (to the University of Virginia) 
      from Insulet, Tandem Diabetes Care, Dexcom, Roche Diagnostics, and Tolerion. T.L. 
      is an employee of Insulet Corporation. R.W.B. reports no personal financial 
      disclosures but reports that his institution has received funding on his behalf 
      as follows: grant funding, study supplies, and consulting fees from Insulet, 
      Tandem Diabetes Care, and Beta Bionics; grant funding and study supplies from 
      Dexcom; grant funding from Bigfoot Biomedical; study supplies from Medtronic, 
      Ascensia, and Roche; consulting fees and study supplies from Eli Lilly and Novo 
      Nordisk; and consulting fees from Embecta, Vertex, Hagar, Ypsomed, and Zucara. 
      R.L. has received consulting fees from Abbott Diabetes Care, Biolinq, Capillary 
      Biomedical, Deep Valley Labs, Morgan Stanley, Gluroo, ProventionBio, PhysioLogic 
      Devices, and Tidepool. He receives research support from NIDDK, JDRF, Insulet, 
      Medtronic, and Tandem. T.T.L. is a fulltime employee of and owns stock in 
      Insulet. B.B. has been on advisory boards for Medtronic Diabetes, Novo Nordisk, 
      Lilly, and received research funding from Insulet, Medtronic, Tandem, JDRF, and 
      the NIDDK. F.J.P. has received research support (to Emory University) from 
      Dexcom, Insulet, Novo Nordisk, and Ideal Medical Technologies, and has received 
      consulting fees from Boehringer Ingelheim, Dexcom, and Medscape. All other 
      authors declare no competing interests.
EDAT- 2023/08/14 12:43
MHDA- 2023/10/30 06:47
PMCR- 2023/10/12
CRDT- 2023/08/14 11:35
PHST- 2023/10/30 06:47 [medline]
PHST- 2023/08/14 12:43 [pubmed]
PHST- 2023/08/14 11:35 [entrez]
PHST- 2023/10/12 00:00 [pmc-release]
AID - 10.1089/dia.2023.0304 [pii]
AID - 10.1089/dia.2023.0304 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2023 Oct;25(10):677-688. doi: 10.1089/dia.2023.0304. Epub 
      2023 Aug 28.