NCT07663136

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,800

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Jun 2029

Study Start

First participant enrolled

June 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

type 1 diabetes home screening kittype 1 diabetes

Outcome Measures

Primary Outcomes (2)

  • Rates of Returned Home Screening Kits

    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

    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 Outcomes (1)

  • Percent of Kits with Adequate Blood Volume

    From enrollment to the end of study at 3 years.

Study Arms (2)

Low-touch intervention

EXPERIMENTAL
Behavioral: email/mail

High-touch intervention

EXPERIMENTAL
Behavioral: phone call

Interventions

phone callBEHAVIORAL

Recruitment through phone call

High-touch intervention
email/mailBEHAVIORAL

Recruitment through email and mail

Low-touch intervention

Eligibility Criteria

Age1 Year - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Maureen Mullen Montagano

CONTACT

Adarsh Viswanath

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations