Making linked real-world diabetes data more reliable

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

['FUNDING_R01'] · HARVARD PILGRIM HEALTH CARE, INC. · NIH-11302635

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

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorHARVARD PILGRIM HEALTH CARE, INC. (nih funded)
Locations1 site (Canton, UNITED STATES)
Trial IDNIH-11302635 on ClinicalTrials.gov

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.

Who could benefit from this research

Good fit: 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.

Not a fit: 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.

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 performed: 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

Canton, UNITED STATES

Researchers

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 below.

View on NIH RePORTER →

Last reviewed 2026-05-15 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.