Real-world accuracy, extended-wear performance, and user satisfaction with a novel 21-day continuous glucose monitoring system in pediatric type 1 diabetes
Year: 2026
Type: article
Abstract: Introduction Extended-wear continuous glucose monitoring (CGM) may reduce device burden in pediatric type 1 diabetes (T1D), but accuracy must be maintained throughout the labeled sensor lifetime. This study was designed to evaluate device performance under routine clinical conditions rather than under controlled laboratory conditions. We evaluated the real-world accuracy, 21-day wear-period performance, glycemic profile, and user satisfaction of the Instara-1 21-day CGM system.Research design and methods CGM readings were paired with the temporally nearest capillary reference glucose value within the predefined matching window. Sensor accuracy was assessed by calculating the mean absolute relative difference (MARD) using paired capillary fingerstick blood glucose measurements as the reference. The primary accuracy analysis used the ±10-minute matching window after exclusion of values flagged as >50% outliers. Accuracy was assessed using MARD, ±20/20 agreement, Bland-Altman analysis in both absolute and relative percentage terms, daily MARD across 21 days, and glucose-range stratification. CGM-derived glycemic metrics were summarized in 52 participants, and user satisfaction was evaluated with a Turkish questionnaire validated for children and adolescents.Results The primary ±10-minute analysis included 2386 paired values. Overall, MARD was 8.4%, median ARD was 5.4%, and CGM-reference correlation was strong (r=0.965). Overall, 90.7% of paired values were within the ±20/20 agreement band. Bland-Altman analysis showed a small negative absolute bias (−6.2 mg/dL; 95% limits of agreement −50.6 to +38.2 mg/dL) and a relative percentage bias of −3.1% (95% limits of agreement −28.4% to +22.1%). Daily MARD remained stable across 21 days, and all sensors except one completed the full 21-day wear period. In the 52-patient cohort, mean glucose was 176.98±42.37 mg/dL, time in range was 52.74±20.34%, and coefficient of variation was 39.36±8.24%. In the analytical satisfaction dataset, the total satisfaction score was 4.35±0.61, and 78.4% had a total score ≥4.Conclusions The Instara-1 21-day CGM system demonstrated clinically acceptable real-world accuracy in pediatric T1D, with stable performance across the full labeled wear period and high user satisfaction.
Institution: Bursa Uludağ Üni̇versi̇tesi̇
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
OpenAlex ID: W7223093301