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Published in: European Journal of Pediatrics 4/2023

Open Access 17-02-2023 | Insulin Glargine | RESEARCH

The efficacy of insulin degludec and insulin glargine over NPH insulin among toddlers and preschoolers with type 1 diabetes using glycemic variability and time in range

Authors: Safinaz Adel Elhabashy, Eman Mohamed Sakr, Nouran Yousef Salah

Published in: European Journal of Pediatrics | Issue 4/2023

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Abstract

Optimizing glycemic control without risking hypoglycemia is crucial in toddlers and preschoolers with type 1 diabetes (T1D) to avoid cognitive impairment later in life. Hence, this study aims to compare glycemic parameters among toddlers and preschoolers with T1D in relation to different basal insulins. Sixty toddlers and preschoolers with T1D with mean age of 3.53 ± 1.17 years (range, 2–6) and mean diabetes duration of 9.37 ± 1.85 months were randomly assigned into three equal groups; group A received insulin degludec, group B received insulin glargine, and group C were on NPH. At baseline, the three groups were matched regarding clinical and laboratory parameters (p > 0.05). They were followed up at 3 and 6 months for insulin daily dose (IDD), hypoglycemia and severe-hypoglycemia frequency, and glycated hemoglobin (HbA1c). At the study endpoint, continuous glucose monitoring (CGM) was assessed in a random sample of 10 patients from each group. The mean time in range (TIR) of the studied cohort was 55.07 ± 24.05%, and their mean coefficient of variation (CV) was 42.82 ± 11.69%. The TIR was significantly higher in the degludec group (69.36 ± 18.54) and the glargine group (55.43 ± 26.51) than the NPH group (32.56 ± 9.11), p < 0.001. Meanwhile, the CV was significantly lower in the degludec group (35.12 ± 6.47) than the gargine (44.1 ± 13.13) and the NPH (53.8 ± 7.54) groups, p < 0.001. The insulin degludec and glargine groups had significantly lower HbA1c (p = 0.002), hypoglycemia (p = 0.006), severe hypoglycemia (p = 0.029), and IDD (p = 0.015) than the NPH group.
Conclusion: Insulin degludec and glargine resulted in better HbA1c and TIR with reduced hypoglycemia and IDD than NPH among toddlers and preschoolers with T1D. Moreover, CV was lowest in the insulin degludec group.
What is Known:
• Insulin therapy is the mainstay of T1D management.
• Optimal insulin therapy for young children with T1D should provide effective glycemic.
What is New:
• Insulin degludec and insulin glargine have better efficacy than NPH insulin among toddlers and preschoolers with T1D in the term of significantly lower coefficient of variation, HbA1c and IDD and significantly higher time in range.
• Insulin degludec and insulin glargine have better safety in the term of less hypoglycemia and severe hypoglycemia episodes than NPH insulin among toddlers and preschoolers with T1D.
Literature
1.
go back to reference Streisand R, Monoghan M (2014) Young children with type 1 diabetes: challenges, research, and future directions. Curr Diab Rep 14:1–9CrossRef Streisand R, Monoghan M (2014) Young children with type 1 diabetes: challenges, research, and future directions. Curr Diab Rep 14:1–9CrossRef
2.
go back to reference Halipchuk J, Sawatsky L (2017) Toddlers with Type 1 Diabetes in daycare: issues with administering insulin lessen options. Can J Diabetes 41(5):474–475CrossRefPubMed Halipchuk J, Sawatsky L (2017) Toddlers with Type 1 Diabetes in daycare: issues with administering insulin lessen options. Can J Diabetes 41(5):474–475CrossRefPubMed
3.
7.
go back to reference Dovc K, Cargnelutti K, Sturm A, Selb J, Bratina N, Battelino T (2019) Continuous glucose monitoring use and glucose variability in pre-school children with type 1 diabetes. Diabetes Res Clin Pract 147:76–80CrossRefPubMed Dovc K, Cargnelutti K, Sturm A, Selb J, Bratina N, Battelino T (2019) Continuous glucose monitoring use and glucose variability in pre-school children with type 1 diabetes. Diabetes Res Clin Pract 147:76–80CrossRefPubMed
9.
go back to reference Siegmund T, Tentolouris N, Knudsen ST et al (2018) A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes. Diabetes Obes Metab 20:689–697. https://doi.org/10.1111/dom.13149CrossRefPubMed Siegmund T, Tentolouris N, Knudsen ST et al (2018) A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes. Diabetes Obes Metab 20:689–697. https://​doi.​org/​10.​1111/​dom.​13149CrossRefPubMed
10.
go back to reference Heise T, Nørskov M, Nosek L, Kaplan K, Famulla S, Haahr HL (2017) Insulin degludec: lower day-to-day and within-day variability in pharmacodynamics response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab 19:1032–1039CrossRefPubMedPubMedCentral Heise T, Nørskov M, Nosek L, Kaplan K, Famulla S, Haahr HL (2017) Insulin degludec: lower day-to-day and within-day variability in pharmacodynamics response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab 19:1032–1039CrossRefPubMedPubMedCentral
11.
go back to reference Davies M, Sasaki T, Gross JL et al (2016) Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1-year treat-to-target trial. Diabetes Obes Metab 18:96–99CrossRefPubMed Davies M, Sasaki T, Gross JL et al (2016) Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1-year treat-to-target trial. Diabetes Obes Metab 18:96–99CrossRefPubMed
12.
go back to reference Lane WS, Bailey TS, Gerety G et al (2017) Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA 318:33–44CrossRefPubMedPubMedCentral Lane WS, Bailey TS, Gerety G et al (2017) Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA 318:33–44CrossRefPubMedPubMedCentral
13.
go back to reference Wysham CH, Bhargava A, Chaykin LB et al (2017) Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: the SWITCH 2 randomized clinical trial. JAMA 318:45–56CrossRefPubMedPubMedCentral Wysham CH, Bhargava A, Chaykin LB et al (2017) Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: the SWITCH 2 randomized clinical trial. JAMA 318:45–56CrossRefPubMedPubMedCentral
14.
go back to reference Fullerton B, Siebenhofer A, Jeitler K et al (2016) Short‐acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus. Cochrane Database Syst Rev 6:CD012161 Fullerton B, Siebenhofer A, Jeitler K et al (2016) Short‐acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus. Cochrane Database Syst Rev 6:CD012161
18.
go back to reference World Health Organization (2006) Department of Nutrition for Health and Development. WHO Child Growth Standards. Length/height-for-age, weight-for-age, weight-for-length, weight-for-height, and body mass index-for-age. Meth Dev Geneva 301–304 World Health Organization (2006) Department of Nutrition for Health and Development. WHO Child Growth Standards. Length/height-for-age, weight-for-age, weight-for-length, weight-for-height, and body mass index-for-age. Meth Dev Geneva 301–304
19.
go back to reference Salinas M, López-Garrigós M, Flores E, Lugo J, Leiva-Salinas C, PRIMary Care-LABoratory (PRIMLAB) Working Group (2019) Laboratory computer-based interventions for better adherence to guidelines in the diagnosis and monitoring of type 2 diabetes. Diabetes therapy: research, treatment and education of diabetes and related disorders. 10(3):995–1003. https://doi.org/10.1007/s13300-019-0600-z Salinas M, López-Garrigós M, Flores E, Lugo J, Leiva-Salinas C, PRIMary Care-LABoratory (PRIMLAB) Working Group (2019) Laboratory computer-based interventions for better adherence to guidelines in the diagnosis and monitoring of type 2 diabetes. Diabetes therapy: research, treatment and education of diabetes and related disorders. 10(3):995–1003. https://​doi.​org/​10.​1007/​s13300-019-0600-z
22.
go back to reference Colino E, Lopez C, Golmayo L, Alvarez MA, Alonso M, Barrio R (2005) Therapy with insulin glargine (Lantus®) in toddlers, children and adolescents with type 1 diabetes. Diabetes Res Clin Pract 70:1–7CrossRefPubMed Colino E, Lopez C, Golmayo L, Alvarez MA, Alonso M, Barrio R (2005) Therapy with insulin glargine (Lantus®) in toddlers, children and adolescents with type 1 diabetes. Diabetes Res Clin Pract 70:1–7CrossRefPubMed
23.
go back to reference Cogen F, Henderson C, Guttmann-Baumann I (2004) Basal/bolus regimen using insulin glargine and rapid-acting insulin analogs in children under 6 years of age: a clinical experience in a large urban practice. Diabetes 53(2):A420 Cogen F, Henderson C, Guttmann-Baumann I (2004) Basal/bolus regimen using insulin glargine and rapid-acting insulin analogs in children under 6 years of age: a clinical experience in a large urban practice. Diabetes 53(2):A420
25.
go back to reference Danne T, Philotheou A, Goldman D, Guo X, Ping L, Cali A, Johnston P (2013) A randomized trial comparing the rate of hypoglycemia—assessed using continuous glucose monitoring—in 125 preschool children with type 1 diabetes treated with insulin glargine or NPH insulin (the PRESCHOOL study). Pediatr Diabetes 14:593–601CrossRefPubMed Danne T, Philotheou A, Goldman D, Guo X, Ping L, Cali A, Johnston P (2013) A randomized trial comparing the rate of hypoglycemia—assessed using continuous glucose monitoring—in 125 preschool children with type 1 diabetes treated with insulin glargine or NPH insulin (the PRESCHOOL study). Pediatr Diabetes 14:593–601CrossRefPubMed
26.
go back to reference Hathout EH, Fujishige L, Geach J, Ischandar M, Maruo S, Mace JW (2003) Effect of therapy with insulin glargine (lantus) on glycemic control in toddlers, children, and adolescents with diabetes. Diabetes Technol Ther 5:801–806CrossRefPubMed Hathout EH, Fujishige L, Geach J, Ischandar M, Maruo S, Mace JW (2003) Effect of therapy with insulin glargine (lantus) on glycemic control in toddlers, children, and adolescents with diabetes. Diabetes Technol Ther 5:801–806CrossRefPubMed
28.
go back to reference Mazaika P, Weinzimer S, Mauras N, Buckingham B, White N, Tsalikian E et al (2016) Variations in brain volume and growth in young children with type 1 diabetes. Diabetes 65:476–485CrossRefPubMed Mazaika P, Weinzimer S, Mauras N, Buckingham B, White N, Tsalikian E et al (2016) Variations in brain volume and growth in young children with type 1 diabetes. Diabetes 65:476–485CrossRefPubMed
29.
go back to reference DiMeglio LA, Kanapka LG, DeSalvo DJ et al (2020) Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study. Diabet Med 37:1308–1315CrossRefPubMedPubMedCentral DiMeglio LA, Kanapka LG, DeSalvo DJ et al (2020) Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study. Diabet Med 37:1308–1315CrossRefPubMedPubMedCentral
30.
go back to reference Miura H, Sakaguchi K, Kaneko A, Ito J, Morita Y, Yamada T, Otowa-Suematsu N, So A, Nakamura T, Komada H, Okada Y, Hirota Y, Tamori Y, Ogawa W (2020) 1020-P: Effects of insulin degludec and insulin glargine U300 on interday glycemic variability in individuals with type 1 diabetes: a multicenter, randomized, crossover study. Diabetes 69(Supplement_1):1020–P Miura H, Sakaguchi K, Kaneko A, Ito J, Morita Y, Yamada T, Otowa-Suematsu N, So A, Nakamura T, Komada H, Okada Y, Hirota Y, Tamori Y, Ogawa W (2020) 1020-P: Effects of insulin degludec and insulin glargine U300 on interday glycemic variability in individuals with type 1 diabetes: a multicenter, randomized, crossover study. Diabetes 69(Supplement_1):1020–P
33.
go back to reference Rollin G, Punales M, Geremia C, Vissoky G, Tschiedel B (2009) Utilização da insulina glargina em crianças menores de oito anos de idade. Arq Bras Endocrinol Metab 53(6):721–725CrossRef Rollin G, Punales M, Geremia C, Vissoky G, Tschiedel B (2009) Utilização da insulina glargina em crianças menores de oito anos de idade. Arq Bras Endocrinol Metab 53(6):721–725CrossRef
34.
go back to reference Predieri B, Suprani T, Maltoni G, Graziani V, Bruzzi P, Zucchini S, Iughetti L (2018) Switching from glargine to degludec: the effect on metabolic control and safety during 1-year of real clinical practice in children and adolescents with type 1 diabetes. Front Endocrinol 9:(462). https://doi.org/10.3389/fendo.2018.00462 Predieri B, Suprani T, Maltoni G, Graziani V, Bruzzi P, Zucchini S, Iughetti L (2018) Switching from glargine to degludec: the effect on metabolic control and safety during 1-year of real clinical practice in children and adolescents with type 1 diabetes. Front Endocrinol 9:(462). https://​doi.​org/​10.​3389/​fendo.​2018.​00462
Metadata
Title
The efficacy of insulin degludec and insulin glargine over NPH insulin among toddlers and preschoolers with type 1 diabetes using glycemic variability and time in range
Authors
Safinaz Adel Elhabashy
Eman Mohamed Sakr
Nouran Yousef Salah
Publication date
17-02-2023
Publisher
Springer Berlin Heidelberg
Published in
European Journal of Pediatrics / Issue 4/2023
Print ISSN: 0340-6199
Electronic ISSN: 1432-1076
DOI
https://doi.org/10.1007/s00431-023-04857-w

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