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Effect of Oral Insulin on Early Combined Glucose and C-Peptide Endpoints in Individuals at High-Risk for Type 1 Diabetes

Background

The TrialNet Oral Insulin (OI) prevention trial did not show a clear overall benefit when looking at type 1 diabetes as the main goal. However, a delay in the onset of diabetes was observed in a specific group of participants at high risk.

Study Overview

This analysis focused on a new approach to measure treatment effects after one year, using glucose and C-peptide markers. Participants were followed for an average of 2.7 years.

Key Findings

Among the participants who had multiple islet autoantibodies and low first-phase insulin release (40 individuals), the results were:

  • In the placebo group, glucose levels increased, and C-peptide levels decreased.
  • In the OI group, glucose levels rose slightly, while C-peptide levels increased.

When comparing these changes using specific time points during a glucose tolerance test, the two groups showed significant differences.

Conclusion

The results suggest that oral insulin may have a positive early effect on glucose and C-peptide levels in individuals at high risk for type 1 diabetes. This could lead to shorter and more efficient clinical trials.

Measurable Outcomes

Define clear goals for clinics and patients regarding the impact of oral insulin on glucose and C-peptide levels in high-risk individuals.

AI Tools for Clinical Needs

Select AI solutions that are specifically designed to meet the requirements of this study and improve patient management.

Implementation Steps

Start with a pilot project to monitor results using AI solutions based on the findings of this study. Track the real-world impact on patient health.

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