Performance of a dual-hormone closed-loop system versus insulin-only closed-loop system in adolescents with type 1 diabetes. A single-blind, randomized, controlled, crossover trial

被引:2
|
作者
Lindkvist, Emilie Bundgaard [1 ,2 ]
Laugesen, Christian [1 ,2 ]
Reenberg, Asbjorn Thode [3 ]
Ritschel, Tobias Kasper Skov [3 ]
Svensson, Jannet [1 ,4 ]
Jorgensen, John Bagterp [3 ]
Norgaard, Kirsten [1 ,2 ]
Ranjan, Ajenthen G. G. [1 ,5 ]
机构
[1] Copenhagen Univ Hosp, Steno Diabet Ctr Copenhagen, Herlev, Denmark
[2] Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark
[3] Tech Univ Denmark, Dept Appl Math & Comp Sci, Lyngby, Denmark
[4] Herlev & Gentofte Univ Hosp, Dept Pediat, Herlev, Denmark
[5] Danish Diabet Acad, Odense, Denmark
来源
关键词
type 1 diabetes mellitus; adolescents; dual-hormone; advanced hybrid closed-loop; artificial pancreas; non-linear model predictive control; moderate intensity continuous exercise; ARTIFICIAL PANCREAS; OPEN-LABEL; GLYCEMIC CONTROL; PUMP THERAPY; GLUCOSE; OUTPATIENT; PAIN;
D O I
10.3389/fendo.2023.1073388
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectiveTo assess the efficacy and safety of a dual-hormone (DH [insulin and glucagon]) closed-loop system compared to a single-hormone (SH [insulin only]) closed-loop system in adolescents with type 1 diabetes. MethodsThis was a 26-hour, two-period, randomized, crossover, inpatient study involving 11 adolescents with type 1 diabetes (nine males [82%], mean +/- SD age 14.8 +/- 1.4 years, diabetes duration 5.7 +/- 2.3 years). Except for the treatment configuration of the DiaCon Artificial Pancreas: DH or SH, experimental visits were identical consisting of: an overnight stay (10:00 pm until 7:30 am), several meals/snacks, and a 45-minute bout of moderate intensity continuous exercise. The primary endpoint was percentage of time spent with sensor glucose values below range (TBR [<3.9 mmol/L]) during closed-loop control over the 26-h period (5:00 pm, day 1 to 7:00 pm, day 2). ResultsOverall, there were no differences between DH and SH for the following glycemic outcomes (median [IQR]): TBR 1.6 [0.0, 2.4] vs. 1.28 [0.16, 3.19]%, p=1.00; time in range (TIR [3.9-10.0 mmol/L]) 68.4 [48.7, 76.8] vs. 75.7 [69.8, 87.1]%, p=0.08; and time above range (TAR [>10.0 mmol/L]) 28.1 [18.1, 49.8] vs. 23.3 [12.3, 27.2]%, p=0.10. Mean ( +/- SD) glucose was higher during DH than SH (8.7 ( +/- 3.2) vs. 8.1 ( +/- 3.0) mmol/L, p<0.001) but coefficient of variation was similar (34.8 ( +/- 6.8) vs. 37.3 ( +/- 8.6)%, p=0.20). The average amount of rescue carbohydrates was similar between DH and SH (6.8 ( +/- 12.3) vs. 9.5 ( +/- 15.4) grams/participant/visit, p=0.78). Overnight, TIR was higher, TAR was lower during the SH visit compared to DH. During and after exercise (4:30 pm until 7 pm) the SH configuration produced higher TIR, but similar TAR and TBR compared to the DH configuration. ConclusionsDH and SH performed similarly in adolescents with type 1 diabetes during a 26-hour inpatient monitoring period involving several metabolic challenges including feeding and exercise. However, during the night and around exercise, the SH configuration outperformed DH.
引用
收藏
页数:10
相关论文
共 50 条
  • [1] Performance of a Dual Hormone Closed-Loop System vs.an Insulin-Only Closed -Loop System during Challenging Inpatient Conditions: A Single-Blinded Randomized Controlled Crossover Trial
    Ranjan, Ajenthen G.
    Boiroux, Dimitri
    Laugesen, Christian
    Schmidt, Signe
    Reenberg, Asbjorn T.
    Jorgensen, John B.
    Norgaard, Kirsten
    [J]. DIABETES, 2021, 70
  • [2] PERFORMANCE OF A DUAL-HORMONE CLOSEDLOOP SYSTEM VERSUS INSULIN-ONLY CLOSEDLOOP IN ADOLESCENTS WITH TYPE 1 DIABETES. A SINGLE-BLIND, RANDOMIZED, CONTROLLED, CROS-OVER TRIAL
    Lindkvist, E.
    Laugesen, C.
    Reenberg, A. Thode
    Ritschel, T.
    Svensson, J.
    Jorgensen, J.
    Ranjan, A.
    Norgaard, K.
    [J]. DIABETES TECHNOLOGY & THERAPEUTICS, 2023, 25 : A50 - A50
  • [3] 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
    Wilson, Leah M.
    Jacobs, Peter G.
    Ramsey, Katrina L.
    Resalat, Navid
    Reddy, Ravi
    Branigan, Deborah
    Leitschuh, Joseph
    Gabo, Virginia
    Guillot, Florian
    Senf, Brian
    El Youssef, Joseph
    Steineck, Isabelle Isa Kristin
    Tyler, Nichole S.
    Castle, Jessica R.
    [J]. DIABETES CARE, 2020, 43 (11) : 2721 - 2729
  • [4] Dual-Hormone Closed-Loop (CL) System in Adults With Type 1 Diabetes (T1D): Randomized Crossover Trial
    Haidar, Ahmad
    Dallaire, Maryse
    Mathieu, Annabelle
    Alkha-Teeb, Ammar
    Coriati, Adele
    Tardif, Annie
    Messier, Virginie
    Millette, Maude
    Cheng, Peiyao
    Boulet, Benoit
    Legault, Laurent
    Rabasa-Lhoret, Remi
    [J]. DIABETES, 2012, 61 : A59 - A59
  • [5] Results of Interim Analysis of a Randomized Crossover Study in Type 1 Diabetes (T1D) of a Dual-Hormone Closed-Loop System with Xerisol™ Glucagon vs. Insulin-Only Closed-Loop System vs. a Predictive Low Glucose Suspend System
    Wilson, Leah M.
    Jacobs, Peter G.
    Resalat, Navid
    Reddy, Ravi
    El Youssef, Joseph
    Branigan, Deborah
    Leitschuh, Joseph A.
    Senf, Brian
    Virginia, Gabo .
    Castle, Jessica R.
    [J]. DIABETES, 2019, 68
  • [6] Role of Dual-Hormone Closed-Loop Delivery System in the Future
    Bally, Lia
    Thabit, Hood
    Hovorka, Roman
    [J]. DIABETES TECHNOLOGY & THERAPEUTICS, 2016, 18 (08) : 452 - 454
  • [7] Use of Dual Hormone (Glucagone) vs Single Hormone (Insulin) in the Treatment of Diabetes with Closed-loop System
    Battelino, Tadej
    [J]. HORMONE RESEARCH IN PAEDIATRICS, 2016, 86 : 24 - 24
  • [8] A Randomized Trial of Closed-Loop Insulin Delivery Postpartum in Type 1 Diabetes
    Donovan, Lois E.
    Feig, Denice S.
    Lemieux, Patricia
    Murphy, Helen R.
    Bell, Rhonda C.
    Sigal, Ronald J.
    Ho, Josephine
    Virtanen, Heidi
    Crawford, Susan
    Yamamoto, Jennifer M.
    [J]. DIABETES CARE, 2023, 46 (12) : 2258 - 2266
  • [9] Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial
    Kovatchev, Boris P.
    Kollar, Laura
    Anderson, Stacey M.
    Barnett, Charlotte
    Breton, Marc D.
    Carr, Kelly
    Gildersleeve, Rachel
    Oliveri, Mary C.
    Wakeman, Christian A.
    Brown, Sue A.
    [J]. LANCET DIGITAL HEALTH, 2020, 2 (02): : E64 - E73
  • [10] Closed-Loop Glycemic Control with the Insulin-Only Bionic Pancreas for the Management of Type 2 Diabetes
    Sherwood, Jordan
    Balliro, Courtney A.
    Hillard, Mallory
    Selagamsetty, Rajendranath
    El-Khatib, Firas
    Damiano, Edward
    Russell, Steven J.
    [J]. DIABETES, 2021, 70