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Research

Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial

Ahmad Haidar, Laurent Legault, Maryse Dallaire, Ammar Alkhateeb, Adèle Coriati, Virginie Messier, Peiyao Cheng, Maude Millette, Benoit Boulet and Rémi Rabasa-Lhoret
CMAJ March 05, 2013 185 (4) 297-305; DOI: https://doi.org/10.1503/cmaj.121265
Ahmad Haidar
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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  • For correspondence: ahmad.haidar@mail.mcgill.ca
Laurent Legault
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Maryse Dallaire
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Ammar Alkhateeb
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Adèle Coriati
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Virginie Messier
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Peiyao Cheng
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Maude Millette
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Benoit Boulet
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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Rémi Rabasa-Lhoret
From the Institut de Recherches Cliniques de Montréal (Haidar, Dallaire, Alkhateeb, Coriati, Messier, Rabasa-Lhoret); the Centre for Intelligent Machines, McGill University (Haidar, Boulet); the Montréal Children’s Hospital (Legault, Millette); the Nutrition Department (Rabasa-Lhoret), Université de Montréal; and the Endocrinology Division (Rabasa-Lhoret), Montreal University Hospital, Montréal, Que.; and the Jaeb Center for Health Research (Cheng), Tampa, Fla.
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  • Figure 1:
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    Figure 1:

    Flow of participants through the crossover study, showing the crossover in therapies between visits 1 and 2. The crossed-over streams are shown in parallel on each side of the flow chart. IQR = interquartile range, VO2max = maximum oxygen uptake.

  • Figure 2:
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    Figure 2:

    Profiles (medians and interquartile ranges) of (A) plasma glucose concentration and (B) basal insulin infusion with dual-hormone closed-loop delivery and continuous subcutaneous insulin infusion. (C) The histogram of glucagon delivery during closed-loop delivery.

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    Figure 3:

    Profiles (medians and interquartile ranges) of plasma glucose concentration and basal insulin infusion before and after receipt of glucagon bolus (n = 61 boluses).

Tables

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    Table 1:

    Comparison of outcomes among 15 adults with type 1 diabetes receiving both interventions

    OutcomeIntervention, median (IQR)*p value†
    Dual-hormone closed-loop deliveryContinuous subcutaenous insulin infusion
    Overall (duration of visit, from 1600 to 0700)
    Plasma glucose level at start of visit, mmol/L7.7 (7.4–10.6)7.0 (5.2–8.7)0.28
    Time spent at specific glucose level, %
     Target range‡70.7 (46.1–88.4)57.3 (25.2–71.8)0.003
     < 4.0 mmol/L0.0 (0.0–3.0)10.2 (0.0–13.0)0.01
     < 3.3 mmol/L0.0 (0.0–0.0)2.8 (0.0–5.9)0.006
     Above target range29.3 (9.4–49.2)25.6 (18.0–63.4)0.17
    Plasma glucose level, mmol/L, mean ± SD7.8 ± 1.17.9 ± 1.90.74
    Plasma glucose level, mmol/L, SD2.0 (1.3–2.8)2.1 (1.8–2.9)0.06
    Insulin delivery, U19 (15–23)19 (15–25)0.19
    Insulin concentration, mU/L25 (23–42)30 (18–43)0.87
    Glucagon concentration, pg/mL66 (61–72)56 (43–65)0.01
    Overnight (from 2300 to 0700)
    Time spent at specific glucose level, %
     Target range72.0 (32.5–84.2)45.8 (29.2–64.6)0.07
     < 4.0 mmol/L0.0 (0.0–0.0)0.0 (0.0–22.5)0.02
     < 3.3 mmol/L0.0 (0.0–0.0)0.0 (0.0–7.7)0.01
     Above target range28.0 (15.8–64.8)49.8 (12.5–70.8)0.99
    Plasma glucose level, mmol/L, mean ± SD7.8 ± 1.37.6 ± 2.30.63
    Plasma glucose level, mmol/L, SD1.5 (1.1–2.6)1.6 (1.1–2.1)0.67
    Insulin delivery, U14 (10–16)14 (9–17)0.77
    Insulin concentration, mU/L24 (19–31)25 (15–33)0.68
    Glucagon concentration, pg/mL57 (45–70)50 (37–61)0.02
    • Note: IQR = interquartile range, SD = standard deviation.

    • ↵* Unless stated otherwise.

    • ↵† Repeated measures analysis.

    • ↵‡ Primary study outcome.

    • View popup
    Table 2:

    Rates of hypoglycemia and nocturnal plasma glucose concentrations among 15 patients with type 1 diabetes during each intervention

    OutcomeIntervention, no. (%)p value*
    Dual-hormone closed-loop delivery
    n = 15
    Continuous subcutaneous insulin infusion
    n = 15
    Patients with at least 1 hypoglycemic event†1 (7)8 (53)0.02
    Patients with at least 1 nocturnal hypoglycemic event†‡0 (0)5 (33)0.07
    Patients with at least 1 exercise-induced hypoglycemic event†§1 (7)2 (13)1.0
    Nocturnal‡ plasma glucose measurements¶n = 363n = 367
     < 4.0 mmol/L2 (0.5)45 (12.3)—
     < 3.3 mmol/L0 (0.0)13 (3.5)—
     < 3.0 mmol/L0 (0.0)9 (2.5)—
    • ↵* McNemar test.

    • ↵† Defined as at least 1 measurement of plasma glucose concentration < 3.0 mmol/L, which was treated by oral carbohydrate.

    • ↵‡ Between the hours of 2300 and 0700.

    • ↵§ From start of exercise to 1920.

    • ↵¶ Measurements were taken at 20-min intervals.

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Canadian Medical Association Journal: 185 (4)
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Vol. 185, Issue 4
5 Mar 2013
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Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial
Ahmad Haidar, Laurent Legault, Maryse Dallaire, Ammar Alkhateeb, Adèle Coriati, Virginie Messier, Peiyao Cheng, Maude Millette, Benoit Boulet, Rémi Rabasa-Lhoret
CMAJ Mar 2013, 185 (4) 297-305; DOI: 10.1503/cmaj.121265

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Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial
Ahmad Haidar, Laurent Legault, Maryse Dallaire, Ammar Alkhateeb, Adèle Coriati, Virginie Messier, Peiyao Cheng, Maude Millette, Benoit Boulet, Rémi Rabasa-Lhoret
CMAJ Mar 2013, 185 (4) 297-305; DOI: 10.1503/cmaj.121265
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