NIH-funded research R01 grant

Making linked real-world diabetes data more reliable

Official title: Improving the VAlidity of LInked real-world DAta sTudiEs for Diabetes Mellitus research (VALIDATE-DM)

Funded at Harvard Pilgrim Health Care, INC. · NIH-11302635 · Data updated 2026-11-12

This project improves how linked health records are used to learn which diabetes medicines work best and are safest for people with diabetes.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionHarvard Pilgrim Health Care, INC.
NIH-funded
Lab location1 site (Canton, UNITED STATES)
Project startMarch 13, 2025
Project endFebruary 28, 2029
Funding year2026
Award (this year)$812,987
NIH project number5R01DK141534-02
Project IDNIH-11302635 on NIH RePORTER

Who could benefit from this research

Could help

People with type 1 or type 2 diabetes whose medical records and insurance claims can be linked in participating health systems or insurers would be most relevant to this work.

Less likely to help

People without diabetes, those whose records are not in the participating databases, or anyone seeking an immediate change in their personal treatment are unlikely to receive direct benefits from this project.

What this research studies

If you have diabetes, this project looks at how doctors and researchers combine different kinds of health records—like electronic health records and insurance claims—to learn which glucose-lowering medicines work best and are safest for people like you. The team links large datasets and develops better study designs and statistical methods to reduce errors and misleading results that can come from incomplete or mismatched records. They focus on comparing different diabetes drugs using these linked records while testing methods to spot and correct biases. The goal is to make real-world evidence more trustworthy so it can better inform treatment choices.

Why it matters

Potential benefit: If successful, this work could give patients clearer, more trustworthy information about the benefits and risks of different diabetes medicines.

How similar studies have gone: Previous studies using claims and EHR data have provided useful insights about diabetes treatments, but linking datasets and correcting for biases remains a developing area with mixed success.

Where this research is happening

  • Harvard Pilgrim Health Care, INC.
    Canton, United States
    Active

Researchers

  • Principal investigator: Toh, Darren — Harvard Pilgrim Health Care, INC.
  • Study coordinator: Toh, Darren

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.