The use of Flash glucose monitoring in children with type 1 diabetes mellitus in real clinical practice

BACKGROUND: In 2018, a Frestyle Libre flash glucose monitoring system (FGM) appeared in Russia and became a potential alternative to the traditional CGM. Studies carried out to date have shown the advantages of FGM over SMBG, but only a few of them relate to real clinical practice, especially in children with type 1 diabetes.
OBJECTIVE: To evaluate the efficacy of FGM in children with T1DM in relation to glycemic control indicators, the occurrence of severe hypoglycemia and diabetic ketoacidosis, as well as the satisfaction of patients and their parents with the use of FGM.
MATERIALS AND METHODS: Single-center, prospective, observational cohort study. Children 4–18 years old with T1DM and HbA1c level less than 10.0% were invited to participate in the study on intensified insulin therapy (by MDI or CSII). The duration of the patient’s participation in the study was 6 months. At baseline and every 3 months thereafter, face-to-face consultations were conducted with an assessment of the general condition, HbA1c study, an assessment of glycemic indicators, progress in relation to glycemic control targets and correction of the therapy. A total of 228 patients (110 boys and 118 girls) who met the inclusion criteria were included in the study. The median age was 11.2 (8.6–14.7) years, the duration of type 1 diabetes was 3.8 (2–7.1), 136 patients received insulin therapy by CSII for 1.3 (0.8–2.6) years.
RESULTS: In the general group of patients, 3 and 6 months after the start of FGM use, the HbA1c values decreased statistically significantly by 0.2%. In addition, the number of children with HbA1c <7.5% increased by 6.1 and 4.9% at 3 and 6 months, respectively, but these changes were not statistically significant. The number of cases of DKA when using FGM decreased by 74%, and the number of cases of severe hypoglycemia by 83%, thus the number of episodes decreased by 4 and 6 times, respectively. Patients and / or their parents rated the ease of use and their experience with FGM on a scale from 0 (strongly agree) to 4 (strongly disagree). The majority of children and parents positively (0 or 1) assessed the convenience of installing and wearing the sensor (72.7–98.2%) using the FGM system in general (75.0–96.4%) and in comparison with the SMBG glucometer (92.3–98.2%).
CONCLUSION: The installation and use of FGM is convenient and comfortable for the vast majority of children and parents, while compared to SMBG, the use of FGM is more convenient and simpler, and glucose measurement is much faster and less painful.

1. Dedov II, Shestakova MV, Mayorov AYu, et al. Standards of specialized diabetes care. Ed. by II Dedov, MV Shestakova, AY Mayorov. Diabetes Mellitus. 2019;22(S1):1-144 (In Russ.)]. doi: https://doi.org/10.14341/DM221S1

2. Peterkova VA, Shestakova MV, Bezlepkina OB, et al. Diabetes mellitus type 1 in childhood. Diabetes mellitus. 2020;23(1S):4-40. (In Russ.)]. doi: https://doi.org/10.14341/DM12504

3. [Dedov II, Shestakova MV, Mayorov AY, et al. Diabetes mellitus type 1 in adults. Diabetes mellitus. 2020;23(1S):42-114. (In Russ.)]. doi: https://doi.org/10.14341/DM12505

4. DiMeglio LA, Acerini CL, Codner E, et al. ISPAD Clinical Practice Consensus Guidelines 2018: Glycemic control targets and glucose monitoring for children, adolescents, and young adults with diabetes. Pediatr Diabetes. 2018;19:105-114. doi: https://doi.org/10.1111/pedi.12737

5. Miller KM, Beck RW, Bergenstal RM, et al. Evidence of a Strong Association Between Frequency of Self-Monitoring of Blood Glucose and Hemoglobin A1c Levels in T1D Exchange Clinic Registry Participants. Diabetes Care. 2013;36(7):2009-2014. doi: https://doi.org/10.2337/dc12-1770

6. Danne T, Nimri R, Battelino T, et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017;40(12):1631-1640. doi: https://doi.org/10.2337/dc17-1600

7. Campbell FM, Murphy NP, Stewart C, et al. Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study. Pediatr Diabetes. 2018;19(7):1294-1301. doi: https://doi.org/10.1111/pedi.12735

8. Messaaoui A, Tenoutasse S, Crenier L. Flash Glucose Monitoring Accepted in Daily Life of Children and Adolescents with Type 1 Diabetes and Reduction of Severe Hypoglycemia in Real-Life Use. Diabetes Technol Ther. 2019;21(6):329-335. doi: https://doi.org/10.1089/dia.2018.0339

9. Al Hayek AA, Robert AA, Al Dawish MA. Evaluation of FreeStyle Libre Flash Glucose Monitoring System on Glycemic Control, Health-Related Quality of Life, and Fear of Hypoglycemia in Patients with Type 1 Diabetes. Clin Med Insights Endocrinol Diabetes. 2017;10:117955141774695. doi: https://doi.org/10.1177/1179551417746957

10. Leiva-Gea I, Vázquez JG, Jurado FRL, et al. Introduction of flash glucose monitoring in children with Type 1 diabetes: experience of a single-centre in Spain. ESPE Abstracts. 2019;92:LB-20.

11. Suzuki J, Urakami T, Yoshida K, et al. Association between scanning frequency of flash glucose monitoring and continuous glucose monitoring‐derived glycemic makers in children and adolescents with type 1 diabetes. Pediatr Int. 2021;63(2):154-159. doi: https://doi.org/10.1111/ped.14412

12. Deeb A, Yousef H, Al Qahtani N, et al. Novel ambulatory glucose-sensing technology improves hypoglycemia detection and patient monitoring adherence in children and adolescents with type 1 diabetes. J Diabetes Metab Disord. 2019;18(1):1-6. doi: https://doi.org/10.1007/s40200-018-0351-9

13. Vergier J, Samper M, Dalla-Vale F, et al. Evaluation of flash glucose monitoring after long-term use: A pediatric survey. Prim Care Diabetes. 2019;13(1):63-70. doi: https://doi.org/10.1016/j.pcd.2018.08.004