Effect of nationwide reimbursement of real-time continuous glucose monitoring on HbA1c, hypoglycemia and quality of life in a pediatric type 1 diabetes population: The RESCUE-pediatrics study

Abstract

Objective: Real-time continuous glucose monitoring (RT-CGM) can improve metabolic control and quality of life (QoL), but long-term real-world data in children with type 1 diabetes (T1D) are scarce. Over a period of 24 months, we assessed the impact of RT-CGM reimbursement on glycemic control and QoL in children/adolescents with T1D treated with insulin pumps.

Research design and methods: We conducted a multicenter prospective observational study. Primary endpoint was the change in HbA1c. Secondary endpoints included change in time in hypoglycemia, QoL, hospitalizations for hypoglycemia and/or ketoacidosis and absenteeism (school for children, work for parents).

Results: Between December 2014 and February 2019, 75 children/adolescents were followed for 12 (n = 62) and 24 months (n = 50). Baseline HbA1c was 7.2 ± 0.7% (55 ± 8mmol/mol) compared to 7.1 ± 0.8% (54 ± 9mmol/mol) at 24 months (p = 1.0). Participants with a baseline HbA1c ≥ 7.5% (n = 27, mean 8.0 ± 0.3%; 64 ± 3mmol/mol) showed an improvement at 4 months (7.6 ± 0.7%; 60 ± 8mmol/mol; p = 0.009) and at 8 months (7.5 ± 0.6%; 58 ± 7mmol/mol; p = 0.006), but not anymore thereafter (endpoint 24 months: 7.7 ± 0.9%; 61 ± 10mmol/mol; p = 0.2). Time in hypoglycemia did not change over time. QoL for parents and children remained stable. Need for assistance by ambulance due to hypoglycemia reduced from 8 to zero times per 100 patient-years (p = 0.02) and work absenteeism for parents decreased from 411 to 214 days per 100 patient-years (p = 0.03), after 24 months.

Conclusion: RT-CGM in pump-treated children/adolescents with T1D showed a temporary improvement in HbA1c in participants with a baseline HbA1c ≥ 7.5%, without increasing time in hypoglycemia. QoL was not affected. Importantly, RT-CGM reduced the need for assistance by ambulance due to hypoglycemia and reduced work absenteeism for parents after 24 months.

Clinical trial registration: [ClinicalTrials.gov], identifier [NCT02601729].

Keywords: HbA1c; hypoglycemia; quality of life; real-time continuous glucose monitoring (RT-CGM); time in range; type 1 diabetes.

Conflict of interest statement

KU Leuven received non-financial support for travel from Medtronic and financial support for travel from Roche for SC. MB reports travel grants from Abbott, Medtronic, Novo-Nordisk, and had served on the advisory panel for Novo Nordisk. KC reports travel grants from Medtronic, Sandoz, and has served in an advisory panel for Novo Nordisk. CDB reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer-Ingelheim, A. Menarini Diagnostics, Eli Lilly, Medtronic, Novo Nordisk, and Roche. PG serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Boehringer-Ingelheim, Janssen Pharmaceuticals, Roche, Medtronic, and Bayer. Financial compensation for these activities has been received by KU Leuven. PG serves or has served on the speaker’s bureau for Merck Sharp and Dohme, Boehringer-Ingelheim, Bayer, Medtronic, Insulet, Novo Nordisk, Abbott, and Roche. Financial compensation for these activities has been received by KU Leuven. KU Leuven received for PG non-financial support for travel from Sanofi-Aventis, A. Menarini Diagnostics, Medtronic, and Roche. All disclosures were unrelated to the present work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 De Ridder, Charleer, Jacobs, Bolsens, Ledeganck, Van Aken, Vanbesien, Gies, Casteels, Massa, Lysy, Logghe, Lebrethon, Depoorter, Gillard, De Block and den Brinker.

Figures

FIGURE 1

Evolution of HbA1c (mean ± SEM) from the start of the reimbursement program until 24 months later. HbA1c of the intention-to-treat population. Assessments per subpopulation: (A) by HbA1c level at entry. (B) By puberty or not pubertal yet at the start of RT-CGM therapy and (C) by being hypoglycemia aware or having impaired hypoglycemia awareness. Values at 4, 8, 12, and 24 months were compared with the values at baseline. Asterisks denote statistical significance for comparison, with *p < 0.05 and **p < 0.005.

FIGURE 2

Evolution of glycemic values by CGM readings (mean ± SD) from the first 2 weeks of the reimbursement program until 24 months later, in the total population. Values at 4, 8, 12, and 24 months were compared with the values at baseline (first 2 weeks). There were no significant differences in time.