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Associations of CGM Metrics With Stimulated C-Peptide Measures in Youth With Recent-Onset Type 1 Diabetes
Anna Neyman1,2, Linda A DiMeglio1, Colleen Bauza3
1Indiana University School of Medicine, Indianapolis, IN.
Insights
Continuous glucose monitoring (CGM) shows moderate correlation with C-peptide levels in type 1 diabetes trials. However, CGM metrics are not yet accurate enough to replace C-peptide measurements in clinical studies.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Clinical Trials
Background:
- Type 1 diabetes (T1D) management relies on assessing residual beta-cell function.
- Stimulated C-peptide measurements are a key outcome in T1D clinical trials.
- Continuous glucose monitoring (CGM) offers frequent glucose data but its utility as a surrogate for C-peptide is under investigation.
Purpose of the Study:
- To evaluate if Continuous glucose monitoring (CGM) metrics can serve as a surrogate for stimulated C-peptide outcomes in type 1 diabetes clinical trials.
- To determine the correlation between CGM parameters and C-peptide levels up to 52 weeks post-diagnosis.
Main Methods:
- A cohort of 103 children with type 1 diabetes was studied.
- Continuous glucose monitoring (CGM) data was collected and compared with C-peptide measurements obtained via mixed-meal tolerance tests.
- Statistical analyses, including Spearman correlations and multivariate modeling, were performed on data collected up to 52 weeks.
Main Results:
- At 52 weeks, CGM metrics demonstrated moderate correlation with C-peptide area under the curve.
- The strongest correlations were observed for time-in-range (70-180 mg/dL), time below 70 mg/dL, and glucose coefficient of variation.
- A multivariate model using these CGM metrics achieved a correlation of 0.63 and predicted peak C-peptide concentrations with 68.4% sensitivity and 75% specificity.
Conclusions:
- CGM measures correlate with stimulated C-peptide levels in children with type 1 diabetes.
- The current strength of correlation and the predictive accuracy (sensitivity and specificity) of CGM-derived measures are insufficient to replace C-peptide measurements in clinical trials.
- Further research may be needed to refine CGM-based surrogates for beta-cell function assessment.
Objective:
Continuous glucose monitoring (CGM) measures could be a surrogate for stimulated C-peptide outcomes in type 1 diabetes trials.
Research Design And Methods:
CGM and mixed-meal tolerance test-derived C-peptide measures at time points out to 52 weeks after diagnosis were compared in 103 children.
Results:
At 52 weeks, CGM metrics moderately correlated with C-peptide area under the curve. The highest Spearman correlations were for time-in-range 70-180 mg/dL, time <70 mg/dL, and glucose coefficient of variation (0.45, -0.33, and -0.58, respectively; the multivariate model using these three metrics had a slightly higher correlation of 0.63). For predicting peak C-peptide concentrations ≥0.2 pmol/mL, this combination had a sensitivity of 68.4% and specificity of 75%.
Conclusions:
CGM measures correlated with stimulated C-peptide measures; however, the strength of the correlations and sensitivity and specificity of CGM-derived measures were not great enough to replace C-peptide measures in clinical trials.
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