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No Effect of an Automated Bolus Calculator in Pediatric Patients with Type 1 Diabetes on Multiple Daily Injections: The Expert Kids Study

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@article{f80ea3f03a914aeca22c6c7014eb97f1,
title = "No Effect of an Automated Bolus Calculator in Pediatric Patients with Type 1 Diabetes on Multiple Daily Injections: The Expert Kids Study",
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.",
author = "Madsen, {Jens Otto Broby} and Kristina Casteels and Steffen Fieuws and Kurt Kristensen and Koen Vanbrabant and Marta Ramon-Krauel and Jesper Johannesen and {ABC consortium}",
year = "2019",
month = jun,
doi = "10.1089/dia.2019.0064",
language = "English",
volume = "21",
pages = "322--328",
journal = "Diabetes Technology and Therapeutics",
issn = "1520-9156",
publisher = "Mary Ann/Liebert, Inc. Publishers",
number = "6",

}

RIS

TY - JOUR

T1 - No Effect of an Automated Bolus Calculator in Pediatric Patients with Type 1 Diabetes on Multiple Daily Injections

T2 - The Expert Kids Study

AU - Madsen, Jens Otto Broby

AU - Casteels, Kristina

AU - Fieuws, Steffen

AU - Kristensen, Kurt

AU - Vanbrabant, Koen

AU - Ramon-Krauel, Marta

AU - Johannesen, Jesper

AU - ABC consortium

PY - 2019/6

Y1 - 2019/6

N2 - 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.

AB - 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.

U2 - 10.1089/dia.2019.0064

DO - 10.1089/dia.2019.0064

M3 - Journal article

C2 - 31157566

VL - 21

SP - 322

EP - 328

JO - Diabetes Technology and Therapeutics

JF - Diabetes Technology and Therapeutics

SN - 1520-9156

IS - 6

ER -

ID: 58941859