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Weiss, A. ; Huber, E. ; Reinmüller, F. ; Munzinger, A. ; Bonifacio, E. ; Ziegler, A.-G.

Continuous glucose monitoring using the FreeStyle Libre Pro iQ in presymptomatic type 1 diabetes.

Diabetologia, DOI: 10.1007/s00125-026-06852-w (2026)
Publ. Version/Full Text Research data DOI PMC
Open Access Hybrid
Creative Commons Lizenzvertrag
AIMS/HYPOTHESIS: The aim of the study was to evaluate the ability of the FreeStyle Libre Pro iQ continuous glucose monitoring (CGM) system to discriminate between presymptomatic stages of type 1 diabetes and stratify progression to stage 3 type 1 diabetes. The study also aimed to compare the performance of the FreeStyle Libre Pro iQ with that of the Dexcom G6. METHODS: From December 2023 to December 2025, 50 children and adolescents without islet autoantibodies (control participants) and 89 with early-stage (stage 1 or 2) type 1 diabetes underwent CGM with the FreeStyle Libre Pro iQ. Participants with early-stage type 1 diabetes were followed up for the development of stage 3 clinical type 1 diabetes. RESULTS: CGM data were unavailable or incomplete for 13 participants (9%), leaving 126 (91%) for analysis (73 female, median age 10.0 years [IQR 7.9-12.8]). The CGM parameters used-namely the SD, CV, time with glucose levels above 7.8 mmol/l (140 mg/dl; TA140) and 8.9 mmol/l (160 mg/dl; TA160) and time in tight range-differed significantly across participants with no early-stage, stage 1 or stage 2 type 1 diabetes, and between participants with a single dysglycaemia abnormality and those with multiple dysglycaemia abnormalities. One or more of these parameters exceeded the 97.5th percentile of control values in 10 (22%) of the 45 individuals with stage 1 type 1 diabetes and in 13 (52%) of the 25 individuals with stage 2 type 1 diabetes (p=0.017). Two or more of the parameters exceeded the 97.5th percentile threshold in six (13%) of the individuals with stage 1 type 1 diabetes and 11 (44%) of the individuals with stage 2 type 1 diabetes (p=0.0077). The 97.5th percentile threshold for TA140 (i.e. >15%) was exceeded by none of the 45 individuals with stage 1 type 1 diabetes, 10 (40%) of the 25 individuals with stage 2 type 1 diabetes and six of the eight individuals who progressed to clinical diabetes within 1 year, identifying these individuals as rapid progressors. FreeStyle Libre Pro iQ values differed markedly from those previously observed using the Dexcom G6 in a similar cohort. Using the 97.5th percentile of values of control individuals to define CGM abnormalities enabled harmonisation across systems and supported the consistent identification of high-risk individuals. With this approach, the sensitivity for identifying those who progressed to clinical diabetes within 1 year ranged from 75% to 100% for the FreeStyle Libre Pro iQ and from 50% to 100% for the Dexcom G6. CONCLUSIONS/INTERPRETATION: These findings support CGM as a promising tool for staging and risk stratification in early-stage type 1 diabetes, while highlighting the need for system-specific interpretation before use in therapeutic decision-making.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Type 1 Diabetes ; Percentile ; Continuous Glucose Monitoring ; Type 2 Diabetes ; Diabetes Mellitus ; Stage (stratigraphy) ; Human Physiology; Progression; Children
ISSN (print) / ISBN 0012-186X
e-ISSN 1432-0428
Journal Diabetologia
Publisher Springer
Publishing Place Berlin ; Heidelberg [u.a.]
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research (IDF)
Institute of Pancreatic Islet Research (IPI)
Grants Breakthrough T1D
EASD-Novo Nordisk Foundation Diabetes Prize for Excellence
Leona M. and Harry B. Helmsley Charitable Trust
LifeScience Stiftung