Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial.

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  • Additional Information
    • Source:
      Publisher: American Diabetes Association Country of Publication: United States NLM ID: 7805975 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1935-5548 (Electronic) Linking ISSN: 01495992 NLM ISO Abbreviation: Diabetes Care Subsets: MEDLINE
    • Publication Information:
      Publication: Alexandria Va : American Diabetes Association
      Original Publication: New York, American Diabetes Assn.
    • Subject Terms:
      Insulin Infusion Systems* ; Pancreas, Artificial*; Diabetes Mellitus, Type 1/*drug therapy ; Glucagon/*administration & dosage ; Insulin/*administration & dosage; Adult ; Blood Glucose/analysis ; Blood Glucose/drug effects ; Blood Glucose/metabolism ; Cross-Over Studies ; Diabetes Mellitus, Type 1/blood ; Exercise/physiology ; Feasibility Studies ; Female ; Glucagon/adverse effects ; Humans ; Hyperglycemia/chemically induced ; Hyperglycemia/drug therapy ; Hypoglycemia/chemically induced ; Hypoglycemia/drug therapy ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/adverse effects ; Insulin/adverse effects ; Male ; Middle Aged ; Oregon ; Outpatients ; Young Adult
    • Abstract:
      Objective: To assess the efficacy and feasibility of a dual-hormone (DH) closed-loop system with insulin and a novel liquid stable glucagon formulation compared with an insulin-only closed-loop system and a predictive low glucose suspend (PLGS) system.
      Research Design and Methods: In a 76-h, randomized, crossover, outpatient study, 23 participants with type 1 diabetes used three modes of the Oregon Artificial Pancreas system: 1 ) dual-hormone (DH) closed-loop control, 2 ) insulin-only single-hormone (SH) closed-loop control, and 3 ) PLGS system. The primary end point was percentage time in hypoglycemia (<70 mg/dL) from the start of in-clinic aerobic exercise (45 min at 60% VO 2max ) to 4 h after.
      Results: DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5], P = 0.025). There was an increased time in hyperglycemia (>180 mg/dL) during and after exercise for DH versus SH (20.8% DH vs. 6.3% SH, P = 0.038). Mean glucose during the entire study duration was DH, 159.2; SH, 151.6; and PLGS, 163.6 mg/dL. Across the entire study duration, DH resulted in 7.5% more time in target range (70-180 mg/dL) compared with the PLGS system (71.0% vs. 63.4%, P = 0.044). For the entire study duration, DH had 28.2% time in hyperglycemia vs. 25.1% for SH ( P = 0.044) and 34.7% for PLGS ( P = 0.140). Four participants experienced nausea related to glucagon, leading three to withdraw from the study.
      Conclusions: The glucagon formulation demonstrated feasibility in a closed-loop system. The DH system reduced hypoglycemia during and after exercise, with some increase in hyperglycemia.
      (© 2020 by the American Diabetes Association.)
    • Molecular Sequence:
      ClinicalTrials.gov NCT03424044
      figshare 10.2337/figshare.12815861
    • Accession Number:
      0 (Blood Glucose)
      0 (Hypoglycemic Agents)
      0 (Insulin)
      9007-92-5 (Glucagon)
    • Publication Date:
      Date Created: 20200910 Date Completed: 20210524 Latest Revision: 20210524
    • Publication Date:
      20240513
    • Accession Number:
      10.2337/dc19-2267
    • Accession Number:
      32907828