Recruiting

Email & Phone

Sponsor:

Indiana University

Code:

NCT07663136

Conditions

Healthy Adult

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

Interventions

phone call

email/mail

Study Details

Brief summary:

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.

Conditions

Healthy Adult

Type 1 Diabetes (T1D)

Study ID

NCT07663136

Start date

Jul 28, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

3800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Low-touch intervention

experimental: High-touch intervention

Interventions

phone call

Recruitment through phone call

email/mail

Recruitment through email and mail

Primary outcome measure

  • Rates of Returned Home Screening Kits [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Maureen Mullen Montagano

317-274-7677findt1d@iu.edu

Adarsh Viswanath

317-278-5033findt1d@iu.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Emily K Sims, MD

More Information

Sponsor

Indiana University

Last update posted

Oct 2, 2026

Last verified

Jun, 2026

Keywords

  • type 1 diabetes home screening kit
  • type 1 diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Indiana University on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.