Initial Experience with a Novel 21-Day Continuous Glucose Monitoring System in Pediatric Type 1 Diabetic Patients: A Two-Center Initial Accuracy Evaluation
Abstract
Abstract
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Background. All currently marketed factory-calibrated continuous glucose monitoring (CGM) systems are licensed for a maximum wear time of 14 days. We report the first clinical experience with the Perlanova (Instara-1) CGM system, a factory-calibrated device with an extended 21-day sensor wear time, in a pediatric population with type 1 diabetes (T1D).
Methods. In a two-center retrospective evaluation, sensors were applied to pediatric T1D patients aged 4–18 years and worn for up to 21 days. CGM readings were compared against contemporaneous capillary (fingerstick) self-monitoring of blood glucose (SMBG) reference values. Paired data points were generated by matching each reference measurement to the nearest CGM value within a predefined time window. The primary endpoint was the overall mean absolute relative difference (MARD); secondary endpoints included the MARD trajectory across the 21-day wear period, MARD stratified by glycaemic range, Bland–Altman agreement, and consensus error-grid distribution.
Results. A total of 1,523 paired data points from 32 pediatric T1D patients (median age 13 years, range 4–18) were analysed. Using a ±10-minute matching window, the overall MARD was 8.6% (median absolute relative difference 3.8%). Point-of-care agreement was high (87.5% within ±15/15 and 93.1% within ±20/20). CGM and reference glucose were strongly correlated (r = 0.963), and 98.9% of paired points fell within consensus error-grid zones A+B. Bland–Altman analysis showed a small negative bias (−5.9 mg/dL; 95% limits of agreement −50.2 to +38.4 mg/dL). Accuracy was preserved throughout the 21-day wear period, with daily MARD remaining largely within the 5–8% band and no progressive deterioration before day 21.
Conclusion. This first-in-class experience indicates that the 21-day Perlanova CGM system provides clinically acceptable accuracy in pediatric T1D patients, maintained across the full extended wear period. These preliminary findings support larger confirmatory studies using a venous/YSI reference standard.
Keywords: continuous glucose monitoring; type 1 diabetes; pediatrics; MARD; sensor accuracy; extended wear; telemedicine
Keywords:
type 1 diabetes, pediatrics; MARD, sensor accuracy, extended wear, telemedicineDOI
https://doi.org/10.22270/jddt.v16i6.7843References
1. de Bock M, Codner E, Craig ME, Huynh T, Maahs DM, Mahmud FH, et al. ISPAD clinical practice consensus guidelines 2022: Glycemic targets and glucose monitoring for children, adolescents, and young people with diabetes. Pediatr Diabetes. 2022;23:1270-1276. https://doi.org/10.1111/pedi.13455 PMid:36537523 PMCid:PMC10107615
2. American Diabetes Association Professional Practice Committee. 7. Diabetes technology: Standards of Care in Diabetes-2024. Diabetes Care. 2024;47(Suppl 1):S126-S144. https://doi.org/10.2337/dc24-S007 PMid:38078575 PMCid:PMC10725813
3. Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care. 2019;42(8):1593-1603. https://doi.org/10.2337/dci19-0028 PMid:31177185 PMCid:PMC6973648
4. Welsh JB, Zhang X, Puhr SA, et al. Performance of a factory-calibrated, real-time continuous glucose monitoring system in pediatric participants with type 1 diabetes. J Diabetes Sci Technol. 2019;13(2):254-258. https://doi.org/10.1177/1932296818798816 PMid:30198331 PMCid:PMC6399785
5. Clinical Trial Report. Continuous Glucose Monitoring System. Version Number: JT202403WMX-CSR/V1.0, Version Date June 17,2025.
6. Boscari F, Galasso S, Acciaroli G, et al. Performance of three different continuous glucose monitoring systems in children with type 1 diabetes during a diabetes summer camp. Pediatr Diabetes. 2021;22(1):e13190. https://doi.org/10.1111/pedi.13160 PMid:33219728 PMCid:PMC7984061
7. Cengiz E, Tamborlane WV. A tale of two compartments: interstitial versus blood glucose monitoring. Diabetes Technol Ther. 2009;11(Suppl 1):S11-S16. https://doi.org/10.1089/dia.2009.0002 PMid:19469670 PMCid:PMC2903977
8. Basu A, Dube S, Slama M, et al. Time lag of glucose from intravascular to interstitial compartment in humans. Diabetes. 2013;62(12):4083-4087. https://doi.org/10.2337/db13-1132 PMid:24009261 PMCid:PMC3837059
9. International Organization for Standardization. ISO 15197:2013 - In vitro diagnostic test systems: requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva: ISO; 2013.
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Copyright (c) 2026 Erdal Eren , Cemal Aslan , Burhan Küçük , Tayfun Aybek
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