To the content
2 . 2022

Dynamics of the target range parameters of glycemia on the therapy with ultrafast insulin aspart in children with type 1 diabetes mellitus

Abstract

Aim – ​to assess the dynamics of the target range parametres of glycemia after the switching from insulin aspart to ultrafast insulin aspart in children with type 1 diabetes mellitus (T1DM).

Design – ​prospective, open, uncontrolled comparative study.

Material and methods. 16 children, aged 4–17 years, who have T1DM for more than 1 year participated in the study. The group included children with insulin pump therapy and basal bolus insulin therapy with multiple daily injections. Insulin degludek was used as basal insulin for at least 6 months. Bolus insulin aspart was replaced by fast-acting insulin aspart. According to the results of flash glucose monitoring before the insulin switching patients were divided into 2 groups depending on the glycemic variability (coefficient of variation, CV): 1st group – ​with low glycemic variability (CV≤36%), 2nd group – ​with high glycemic variability (CV>36%). Time in/above/below range (level 1, level 2) of the ambulatory glucose profile using the intermittently scanned FreeStyle Libre flash glucose monitoring system (FGM) was assessed. Time in, below, and above the target range was recorded from 4 periods of 14-day glucose monitoring: before insulin switching and 2 weeks, 3 months and 6 months after changing insulin.

Results. According to FGM results six months after the start of fast insulin aspart therapy in 1st group there was a statistically non-significant increase in Time In Range (TIR) values, a decrease in Time Above Range (TAR) and Time Below Range (TBR) values. Glycohemoglobin (HbA1c) and glycemic variability also improved without statistical significance.

2nd group showed a statistically significant increase in TIR after 6 months of using fast insulin aspart (from 40.5±11.2 to 60.0±8.0; p<0.001), decrease in TAR (from 50.8±9.3 to 33.0±7.4; p<0.001) and in TBR (from 11.5±5.4 to 5.2±3.6; p<0.001), CV (from 39.6±3.8 to 34.5±2.8; p<0.001), that had an impact on a statistically significant decrease in the level of HbA1c (from 8.6±1.4 to 6.8±0.7; p<0.05) in the same group of patients.

Conclusion. Usage of ultrafast insulin aspart in children with T1DM allowed to improve the indicators of carbohydrate metabolism: the time in/above/below range (level 1, level 2), the glycemic variability according to the ambulatory glucose profile.

Keywords:type 1 diabetes mellitus; glycemia; continuous monitoring; FreeStyle Libre; flash glucose monitoring; ultrafast-acting insulin

Funding. The study had no sponsor support.

Conflict of interest. The authors declare no conflict of interest.

For citation: Girsh Ya.V., Yusupova N.A. Dynamics of the target range parameters of glycemia on the therapy with ultrafast insulin aspart in children with type 1 diabetes mellitus. Endokrinologiya: novosti, mneniya, obuchenie [Endocrinology: News, Opinions, Training]. 2022; 11 (2): 21–6. DOI: https://doi.org/10.33029/2304-9529-2022-11-2-21-26 (in Russian)

Литература/References

1. Ketema E.B., Kibret K.T. Correlation of fasting and postprandial plasma glucose with HbA1c in assessing glycemic control; systematic review and meta-analysis. Arch Public Health. 2015; 73: 43. DOI: https://doi.org/10.1186/s13690-015-0088-6

2. Home P.D. Plasma insulin profiles after subcutaneous injection: how close can we get to physiology in people with diabetes? Diabetes Obes Metab. 2015; 17 (11): 1011–20. DOI: https://doi.org/10.1111/dom.12501

3. Inzucchi S.E. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015; 38 (1): 140–9. DOI: https://doi.org/10.2337/dc14-2441

4. Dovc K., Battelino T. Time in range centered diabetes care. Clin Pediatr Endocrinol. 2021; 30 (1): 1–10. DOI: https://doi.org/10.1297/cpe.30.1

5. Lane W., et al. 56th EASD Annual Meeting of the European Association for the Study of Diabetes. 2020. Sep. PMID: 32840677. PMCID: PMC 7445463. DOI: https://doi.org/10.1007/s00125-020-05221-5

6. Bode В.W., Johnson J.A., Hyveled L., et al. Improved postprandial glycemic control with faster-acting insulin aspart in patients with type 1 diabetes using continuous subcutaneous insulin infusion. Diabetes Technol. Ther. 2017; 19 (1): 25–33. DOI: https://doi.org/10.1089/dia. 2016.0350

7. Heise T., Pieber T.R., Danne T., et al. A pooled analysis of clinical pharmacology trials investigating the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clin Pharmacokinet. 2017; 56 (5): 551–9. DOI: https://doi.org/10.1007/s40262-017-0514-8

8. Russell-Jones D., Bode В.W., De Block C., et al. Fast-acting insulin aspart improves glycemic control in basal-bolus treatment for type 1 diabetes: results of a 26-week multicenter, active-controlled, treat-to-target, randomized, parallel-group trial (onset 1). Diabetes Care. 2017; 40 (7): 943–50. DOI: https://doi.org/10.2337/dc16-1771

9. Senior P., Hramiak I. Fast-acting insulin aspart and the need for new mealtime insulin analogues in adults with type 1 and type 2 diabetes: a Canadian perspective. Can J Diabetes. 2019; 43 (7): 515–23. DOI: https://doi.org/10.1016/j.jcjd.2019.01.004

10. Klonoff D.C., Evans M.L., Lane W., et al. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019; 21 (4): 961–7. DOI: https://doi.org/10.1111/dom.13610

11. Shiramoto M., Nishida T., Hansen A.K., Haahr H. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018; 9 (2): 303–10. DOI: https://doi.org/10.1111/jdi.12697

12. Billion L., Charleer S., Verbraeken L., et al. Glucose control using fast-acting insulin aspart in a real-world setting: a 1-year, two-centre study in people with type 1 diabetes using continuous glucose monitoring. Diabetes Obes Metab. 2021; 23 (12): 2716–27. DOI: https://doi.org/10.1111/dom.14527

13. Danne T., Nimri R., Battelino T., et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017; 40 (12): 1631–40. DOI: https://doi.org/10.2337/dc17-1600

14. Battelino T., Danne T., Bergenstal R.M., et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care. 2019; 42 (8): 1593–603. DOI: https://doi.org/10.2337/dci19-0028

15. World Medical Association: World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013; 310 (20): 2191–4. DOI: https://doi.org/10.1001/jama.2013.281053

16. Guidelines for Good Pharmacoepidemiology Practice (GPP). Pharmacoepidemiol Drug Saf. 2016; 25 (1): 2–10. DOI: https://doi.org/10.1002/pds.3891

17. Bode B.W., Iotova V., Kovarenko M., et al. Efficacy and safety of fast-acting insulin aspart compared with insulin aspart, both in combination with insulin degludec, in children and adolescents with type 1 diabetes: the onset 7 trial. Diabetes Care. 2019; 42 (7): 1255–62. DOI: https://doi.org/10.2337/dc19-0009

18. Zijlstra E., Demissie M., Graungaard T., et al. Investigation of pump compatibility of fast-acting insulin aspart in subjects with type 1 diabetes. J Diabetes Sci Technol. 2018; 12 (1): 145–151. DOI: https://doi.org/10.1177/1932296817730375

19. Hayek A.A., Robert A.A., Al Dawish M.A. Acceptability of the FreeStyle Libre flash glucose monitoring system: the experience of young patients with type 1 diabetes. Clin Med Insights Endocrinol Diabetes. 2020; 13: 1179551420910122. DOI: https://doi.org/10.1177/1179551420910122

CHIEF EDITOR
CHIEF EDITOR
Ametov Alexander S.
Honored Scientist of the Russian Federation, Doctor of Medical Sciences, Professor, Head of Subdepartment of Endocrinology, Head of the UNESCO Network Chair on the subject «Bioethics of diabetes as a global problem» of the Russian Medical Academy of Continuous Professional Education (Moscow)
Вскрытие
Medicine today

II Всероссийская конференция с международным участием "Воспаление глаза" 12 ноября 2022 года, Москва Воспалительные заболевания глаза - широко распространенная и многогранная проблема, с которой может столкнуться в своей практике любой специалист. Найти оптимальные алгоритмы...

Масштабное событие в области дерматовенерологии и косметологии - II конференция InteDeCo 2022 "Интегративная дерматовенерология и косметология. Новые стандарты взаимодействия" - состоится 16-17 декабря 2022 года. Программа мероприятия пройдет на современной...

VIII Московский Городской Съезд педиатров с межрегиональным и международным участием "Трудный диагноз в педиатрии" Приглашаем педиатров, детских эндокринологов, реаниматологов, гинекологов, неонатологов, кардиологов, хирургов, урологов, психологов, специалистов по лучевой...


Journals of «GEOTAR-Media»