Fall in C-Peptide During First 2 Years From Diagnosis
Open accessAbstract
Interpretation of clinical trials to alter the decline in β-cell function after diagnosis of type 1 diabetes depends on a robust understanding of the natural history of disease. Combining data from the Type 1 Diabetes TrialNet studies, we describe the natural history of β-cell function from shortly after diagnosis through 2 years post study randomization, assess the degree of variability between patients, and investigate factors that may be related to C-peptide preservation or loss. We found that 93% of individuals have detectable C-peptide 2 years from diagnosis. In 11% of subjects, there was no significant fall from baseline by 2 years. There was a biphasic decline in C-peptide; the C-peptide slope was -0.0245 pmol/mL/month (95% CI -0.0271 to -0.0215) through the first 12 months and -0.0079 (-0.0113 to -0.0050) from 12 to 24 months (P < 0.001). This pattern of fall in C-peptide over time has implications for understanding trial results in which effects of therapy are most pronounced early and raises the possibility that there are time-dependent differences in pathophysiology. The robust data on the C-peptide obtained under clinical trial conditions should be used in planning and interpretation of clinical trials.
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The rate of β-cell destruction is quite variable, being rapid in some individuals and slow in others.
“The rate of b -cell destruction is quite variable, being rapid in some individuals (particularly but not exclusively in infants and children) and slow in others (mainly but not exclusively adults) (46,59).”
From 2. Diagnosis and Classification of Diabetes: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [59]
The Results report variability in individual C-peptide decline slopes, and the Discussion says decline was faster in participants aged 7–21 than in those over 21. The paper measures β-cell function rather than β-cell destruction, and its Discussion explicitly says the data cannot support conclusions about children younger than 7, including infants. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe rate of b-cell destruction is quite variable, being rapid in some individuals (particularly but not exclusively in infants and children) and slow in others (mainly but not exclusively adults).
“The rate of b-cell destruction is quite variable, being rapid in some individuals (particularly but not exclusively in infants and children) and slow in others (mainly but not exclusively adults) (44,58).”
From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [58]
The Results report variation in individual C-peptide decline, and the Discussion says decline was faster at ages 7–21 than above age 21. But the paper measures β-cell function after diagnosis, not destruction directly, and explicitly says its data cannot support conclusions about children younger than 7, including infants (Discussion; page unavailable). (LLM, conf=0.88)
Experimental — accuracy not yet measuredAnalysis of C-peptide concentration after disease onset shows that loss is more rapid in the first year after diagnosis than in the second year.
“and analysis of C-peptide concentration after disease onset shows that loss is more rapid in the fi rst year after diagnosis than in the second year.83”
From Type 1 diabetes (2014) · cites this paper as [83]
The Results report a significantly faster C-peptide decline in the first 12 months of observation than in the next 12 months. The Discussion clarifies that observation began a median of 55 days after diagnosis, so those intervals do not correspond exactly to the first and second years after diagnosis; the paper has no data on the rate of decline between diagnosis and study entry. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe loss of β-cell mass probably affects the performance of remaining β cells and other islet cell types.
“The loss of β-cell mass probably affects the performance of remaining β cells and other islet cell types, as shown by functional (and structural) studies.”
From Type 1 diabetes (2014) · cites this paper as [83]
The Discussion describes declining insulin secretion and β-cell destruction in type 1 diabetes, but does not say that loss of β-cell mass changes the function of surviving β cells or other islet cell types. Searches for β-cell mass, structural studies, and other islet cells found no passage addressing that proposed effect. (LLM, conf=0.72)
Experimental — accuracy not yet measured
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- Authors
- Greenbaum, C. J., Beam, C. A., Boulware, D., Gitelman, S. E., Gottlieb, P. A., Herold, K. C., Lachin, J. M., McGee, P., Palmer, J. P., Pescovitz, M. D., Krause-Steinrauf, H., Skyler, J. S., Sosenko, J. M., & on behalf of the Type 1 Diabetes TrialNet Study Group
- Affiliations
- Benaroya Research Institute (US)
- University of South Florida (US)
- University of California, San Francisco (US)
- University of Colorado Denver (US)
- Yale University (US)
- George Washington University (US)
- University of Washington (US)
- Indiana University Indianapolis (US)
- University of Miami (US)
- Corresponding author
- Greenbaum, Carla J.
- ORCID
- Venue
- Diabetes
- Publisher
- American Diabetes Association
- Published
- 2012-07-17
- Volume
- 61
- Issue
- 8
- Pages
- 2066-2073
- ISSN
- 0012-1797 (ISSN-L)
- 1939-327X
- PMC
- PMC3402330
- OpenAlex
- W2429231050
- Cited by
- 319
- References
- 33
- Citations by year
- 2026: 6 · 2025: 16 · 2024: 21 · 2023: 32 · 2022: 19 · 2021: 25 · 2020: 24 · 2019: 24 · 2018: 34 · 2017: 13 · 2016: 24 · 2015: 30 · 2014: 25 · 2013: 22 · 2012: 4
- FWCI
- 15.61
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
- Funders
- American Diabetes Association
- Juvenile Diabetes Research Foundation International
- National Institutes of Health (5ul1rr031986-02, UL1TR001085, UL1TR000130, UL1TR000454)
- National Institute of Diabetes and Digestive and Kidney Diseases (U01-DK-084565, U01DK061040, U01DK085461, U01DK085505, U01DK085499, U01DK061055, U01DK061036, U01DK061010, U01DK061058, U01DK061034, U01DK061042, U01DK085463, U01DK085453, U01DK061041, U01DK085466, U01DK085509, U01 DK-061016)
- U.S. National Library of Medicine (HHSN267200800019C)
- National Center for Research Resources (UL1RR029890, UL1RR024131, M01RR000400, UL1-RR031986, UL1RR025744, UL1RR024153, UL1RR024982, UL1RR025761, KL2RR024977, M01-RR00400, TL1RR024978, UL1RR024975, UL1RR024139, UL1RR025780)
- National Center for Advancing Translational Sciences
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
- Keywords
- type 1 diabetes, C-peptide, beta-cell function, natural history of disease, interindividual variability, clinical trial interpretation
- MeSH terms
- Adolescent, Adult, C-Peptide, Child, Diabetes Mellitus, Type 1, Glucose Tolerance Test, Humans, Insulin, Middle Aged, Randomized Controlled Trials as Topic, Insulin-Secreting Cells
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