Finding Immune Nascent Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-99
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant must be in Indiana Biobank
Participant must be able to provide consent
Ages 1-99 including pregnant women
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
phone call
BehavioralRecruitment through phone call
email/mail
BehavioralRecruitment through email and mail
Treatment groups
3,800 Participants
are divided into 2 treatment groupsGroup A: Low-touch interventionExperimental treatment 1 intervention
Group B: High-touch interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rates of Returned Home Screening Kits
The number of returned screening kits versus the number that were not returned by consented participants.
Time frame
From enrollment to the end of study at 3 years.2
Rates of Consent
The number of participants who consent versus the number of participants who do not consent.
Time frame
From enrollment to the end of study at 3 years.Secondary outcomes
1
Percent of Kits with Adequate Blood Volume
Time frame
From enrollment to the end of study at 3 years.2
Rates of Returned Home Screening Kits
The number of returned screening kits versus the number that were not returned by consented participants. Some of which will receive information that they may be at increased risk of type 1 diabetes.
Time frame
From enrollment to the end of study at 3 years3
Rates of Consent
The number of participants who consent versus the number of participants who do not consent. Some participants will receive information that they may be at increased risk of type 1 diabetes.
Time frame
From enrollment to the end of study at 3 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov