Finding Immune Nascent Type 1 Diabetes (FIND T1D)

June 17, 2026 updated by: Emily K. Sims, Indiana University

Finding Immune Nascent Type 1 Diabetes (FIND T1D)

The goal of this clinical trial is to understand how many individuals who previously participated in the Indiana Biobank will return a type 1 diabetes home screening kit based upon different methods of recruitment communication. The main question it aims to answer is:

What form of recruitment communication is most effective for completing a type 1diabetes home screening kit?

Researchers will compare two types of recruitment contact: email and mail based communication (low-touch) versus phone contact and follow-up by a research team member (high-touch).

Participants will be contacted either via email/mail or by phone and asked if they want to complete a type 1 diabetes home screening kit.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maureen Mullen Montagano
  • Phone Number: 317-274-7677
  • Email: findt1d@iu.edu

Study Contact Backup

  • Name: Adarsh Viswanath
  • Phone Number: 317-278-5033
  • Email: findt1d@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
        • Principal Investigator:
          • Emily K Sims, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant must be in Indiana Biobank
  • Participant must be able to provide consent
  • Ages 1-99 including pregnant women

Exclusion Criteria:

  • Refusal to sign informed consent for home screening is exclusionary for the home screening portion of the study
  • While other medical conditions are allowable prior diabetes diagnosis is exclusionary for home autoantibody screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-touch intervention
Behavioral: email/mail
Recruitment through email and mail
Experimental: High-touch intervention
Behavioral: phone call
Recruitment through phone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Returned Home Screening Kits
Time Frame: From enrollment to the end of study at 3 years.
The number of returned screening kits versus the number that were not returned by consented participants.
From enrollment to the end of study at 3 years.
Rates of Consent
Time Frame: From enrollment to the end of study at 3 years.
The number of participants who consent versus the number of participants who do not consent.
From enrollment to the end of study at 3 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of Kits with Adequate Blood Volume
Time Frame: From enrollment to the end of study at 3 years.
From enrollment to the end of study at 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant results will be shared as summary data but because participants declining consent have not agreed we will not provide individual level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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