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Title: | No Effect of an Automated Bolus Calculator in Pediatric Patients with Type 1 Diabetes on Multiple Daily Injections: The Expert Kids Study | Authors: | Madsen, Jens Otto Broby Casteels, Kristina FIEUWS, Steffen Kristensen, Kurt Vanbrabant, Koen Ramon-Krauel, Marta Johannesen, Jesper Bontinck, Magda Devisscher, Carine Goicoechea, Irune Hertz, Anne Marie Jorgensen, Lene Kolle Vandoorne, Eva Yoldi, Carmen Casteels, Kristian Corripio, Raquel Gonzalez-Vergaz, Amparo Hernandez, Roque Cardona Sanchez, Jacobo Perez Van Aken, Sara Vanbesien, Jesse |
Issue Date: | 2019 | Publisher: | MARY ANN LIEBERT, INC | Source: | Diabetes Technology & Therapeutics, 21(6), p. 322-328 | Abstract: | Background: This multicenter crossover study investigated the potential beneficial effect of an automated bolus calculator (ABC) in children and adolescents with type 1 diabetes (T1D) treated with multiple daily injections (MDI). Methods: Participants were randomized to either begin or end with a 5 months intervention versus their regular treatment regimen (control), separated by a 2 months washout period. During the intervention participants were carefully instructed to use the ABC (Accu-Check Aviva Expert) versus manual insulin calculations during the control period. Participants between 8 and 18 years of age with T1D were recruited from clinics in Denmark, Belgium, and Spain. Inclusion criteria included T1D for >1 year, a minimum of 3 months MDI treatment before inclusion, and HbA1c of 7.5%-11% (57-97 mmol/mol). Improvement in HbA1c was the main outcome, and improved quality of life (QoL) and glucose variability (time spent in target glucose) were secondary outcomes. Results: A total of 65 patients with a mean age of 13.25 years and a mean HbA1c of 8.25% (66.7 mmol/mol) were included. Midway evaluation after 2 months of intervention showed no significant difference from the standard care (0.297, 95% confidence interval [CI]: -0.645 to 0.054; P = 0.10). The difference remained insignificant after the 5 months of intervention (-0.143 [95% CI: -0.558 to 0.272; P = 0.51]). Using the ABC did not change the time spent in target glucose range, nor did it change the QoL. Conclusions: Our study did not demonstrate beneficial additive effects of an ABC in children and adolescents with T1D treated with MDI neither in HbA1c, nor in any other endpoint investigated. | Notes: | [Madsen, Jens Otto Broby; Johannesen, Jesper] Herlev Univ Hosp, Dept Pediat, Herlev, Denmark. [Casteels, Kristina] Univ Hosp Leuven, Dept Pediat, Leuven, Belgium. [Casteels, Kristina] Univ Leuven, Dept Dev & Regenerat, Leuven, Belgium. [Fieuws, Steffen; Vanbrabant, Koen] KU Leuven Univ Leuven, Interuniv Inst Biostat & Stat Bioinformat, Leuven, Belgium. [Fieuws, Steffen; Vanbrabant, Koen] Univ Hasselt, Leuven, Belgium. [Kristensen, Kurt] Skejby Univ Hosp, Dept Pediat, Aarhus, Denmark. [Ramon-Krauel, Marta] Hosp St Joan de Deu, Inst Recerca St Joan de Deu, Dept Endocrinol, Barcelona, Spain. [Johannesen, Jesper] Univ Copenhagen, Fac Hlth & Med Sci, Copenhagen, Denmark. | Keywords: | Automated bolus calculator; type 1 diabetes; Pediatric; Multiple daily injections;Automated bolus calculator; type 1 diabetes; pediatric; multiple daily injections | Document URI: | http://hdl.handle.net/1942/28682 | ISSN: | 1520-9156 | e-ISSN: | 1557-8593 | DOI: | 10.1089/dia.2019.0064 | ISI #: | 000470003300004 | Rights: | Mary Ann Liebert, Inc | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2020 |
Appears in Collections: | Research publications |
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10.1089@dia.2019.0064.pdf Restricted Access | Published version | 313.29 kB | Adobe PDF | View/Open Request a copy |
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