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
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...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-01-01
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| Series: | Frontiers in Endocrinology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fendo.2023.1073388/full |
| _version_ | 1797945498978484224 |
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| author | Emilie Bundgaard Lindkvist Emilie Bundgaard Lindkvist Christian Laugesen Christian Laugesen Asbjørn Thode Reenberg Tobias Kasper Skov Ritschel Jannet Svensson Jannet Svensson John Bagterp Jørgensen Kirsten Nørgaard Kirsten Nørgaard Ajenthen G. Ranjan Ajenthen G. Ranjan |
| author_facet | Emilie Bundgaard Lindkvist Emilie Bundgaard Lindkvist Christian Laugesen Christian Laugesen Asbjørn Thode Reenberg Tobias Kasper Skov Ritschel Jannet Svensson Jannet Svensson John Bagterp Jørgensen Kirsten Nørgaard Kirsten Nørgaard Ajenthen G. Ranjan Ajenthen G. Ranjan |
| author_sort | Emilie Bundgaard Lindkvist |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T20:56:05Z |
| format | Article |
| id | doaj.art-d25ce64ed54e433bb34183579bfdbf77 |
| institution | Directory Open Access Journal |
| issn | 1664-2392 |
| language | English |
| last_indexed | 2024-04-10T20:56:05Z |
| publishDate | 2023-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Endocrinology |
| spelling | doaj.art-d25ce64ed54e433bb34183579bfdbf772023-01-23T05:42:26ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922023-01-011410.3389/fendo.2023.10733881073388Performance 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 trialEmilie Bundgaard Lindkvist0Emilie Bundgaard Lindkvist1Christian Laugesen2Christian Laugesen3Asbjørn Thode Reenberg4Tobias Kasper Skov Ritschel5Jannet Svensson6Jannet Svensson7John Bagterp Jørgensen8Kirsten Nørgaard9Kirsten Nørgaard10Ajenthen G. Ranjan11Ajenthen G. Ranjan12Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, DenmarkDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, DenmarkDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Applied Mathematics and Computer Science, Technical University of Denmark, Kgs. Lyngby, DenmarkDepartment of Applied Mathematics and Computer Science, Technical University of Denmark, Kgs. Lyngby, DenmarkCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, DenmarkDepartment of Pediatrics, Herlev and Gentofte University Hospital, Herlev, DenmarkDepartment of Applied Mathematics and Computer Science, Technical University of Denmark, Kgs. Lyngby, DenmarkCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, DenmarkDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, DenmarkDanish Diabetes Academy, Odense, DenmarkObjectiveTo 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.https://www.frontiersin.org/articles/10.3389/fendo.2023.1073388/fulltype 1 diabetes mellitusadolescentsdual-hormoneadvanced hybrid closed-loopartificial pancreasnon-linear model predictive control |
| spellingShingle | Emilie Bundgaard Lindkvist Emilie Bundgaard Lindkvist Christian Laugesen Christian Laugesen Asbjørn Thode Reenberg Tobias Kasper Skov Ritschel Jannet Svensson Jannet Svensson John Bagterp Jørgensen Kirsten Nørgaard Kirsten Nørgaard Ajenthen G. Ranjan Ajenthen G. Ranjan 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 Frontiers in Endocrinology type 1 diabetes mellitus adolescents dual-hormone advanced hybrid closed-loop artificial pancreas non-linear model predictive control |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | type 1 diabetes mellitus adolescents dual-hormone advanced hybrid closed-loop artificial pancreas non-linear model predictive control |
| url | https://www.frontiersin.org/articles/10.3389/fendo.2023.1073388/full |
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