# Standardization of C-Peptide and HbA1C Measurements Program

> **NIH NIH U01** · UNIVERSITY OF MISSOURI-COLUMBIA · 2022 · $492,975

## Abstract

Project Summary
Diabetes mellitus is a chronic disorder characterized by insulin deficiency,
hyperglycemia and high risk for development of complications of the eyes, kidneys,
peripheral nerves, heart and blood vessels. The disease is highly prevalent,
affecting more than 30 million people in the U.S. Monitoring of glycemic control
has traditionally been considered a cornerstone of diabetes care. The importance
of monitoring glycemia has been established by studies proving a direct
relationship between mean blood glucose and the development and progression of
the chronic complications of diabetes. The landmark Diabetes Control and
Complications Trial (DCCT), completed in 1993, showed that risks for development
and/or progression of the chronic complications of type 1 diabetes is closely
related to the degree of glycemic control, as assessed by HbA1c determinations.
The importance of HbA1c as a marker of glycemic control in diabetes mellitus, and
more recently as a diagnostic tool, is now well established. This proposed project
will improve the measurement of HbA1c for optimal clinical and diagnostic use.
This will be done through an established standardization program by continuously
tightening criteria for method and laboratory certification, monitoring performance
of laboratory methods and laboratories, and testing and publishing data on HbA1c
analytical and biological interferences.
Preservation of beta cell function in type 1 diabetes has been identified as an
important goal in delaying progression of the disease at onset and also for
therapeutic intervention. Accurate, standardized measurement of C-peptide will
aid in this goal and is also the subject of this proposal. Standardization will be
accomplished by implementation of a traceability scheme with re-calibration of C-
peptide methods by each manufacturer and monitoring the effects of re-calibration
by evaluation of proficiency testing data. In addition, criteria will be formulated for
acceptable accuracy, precision and specificity of C-peptide assays.

## Key facts

- **NIH application ID:** 10496203
- **Project number:** 1U01DK133106-01
- **Recipient organization:** UNIVERSITY OF MISSOURI-COLUMBIA
- **Principal Investigator:** Randie Little
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $492,975
- **Award type:** 1
- **Project period:** 2022-07-15 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10496203

## Citation

> US National Institutes of Health, RePORTER application 10496203, Standardization of C-Peptide and HbA1C Measurements Program (1U01DK133106-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10496203. Licensed CC0.

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