Using Technology to Address Disparities and Promote Healthcare Equity in Type 1 Diabetes Registry (EquiT1D)

November 20, 2025 updated by: University of Chicago
This study is being done to see if using technology, with the help of a Patient Navigator, can help address disparities, improve outcomes, and promote healthcare equity in type 1 diabetes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with T1D require an individualized care plan with ongoing education and support. A recent qualitative study of young adults with T1D and end-stage renal disease revealed that childhood environment, education, socio-economic status, and other determinants contributed to disengagement from treatment regimens and the development of microvascular complications early in life1. Providing participants with real-time CGMS will inform daily decision making.

This is an interventional study using prescribed real-time CGMS together with feedback and support from a Patient Navigator in patients with T1D. The aims of this study include the following.

Aim 1: To incorporate real-time CGMS and patient navigation support into the care of adolescent and adult patients with T1D and one of the following: 1.) two or more hospitalizations for DKA in the last five years or 2.) two or more hemoglobin A1c values over 10% in the last two years.

Aim 2: To collect information from participants regarding health outcomes, experiences with health care, and changes, if any, in diabetes self-management practices, diabetes distress, and diabetes health-related quality of life.

Study Type

Interventional

Enrollment (Estimated)

150

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 Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or females age 14 to 64 years
  • Clinical diagnosis of type 1 diabetes (T1D)
  • Two or more hospitalizations with diabetic ketoacidosis (DKA) within the past 5 years or hemoglobin A1c greater than 10% on two or more laboratory samples in the last 2 years.
  • Informed Consent
  • Has a CGMS or a prescription for a CGMS as part of their clinical care as part of their clinical care

Exclusion Criteria:

  • Inability or unwillingness to share CGMS data with the study team

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Navigator
Patient Navigator will provide additional support to participants using their standard of care CGM device.
Behavioral: Patient Navigator
Patient Navigator will provide additional support to participants using their standard of care CGM device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CGM Utilization
Time Frame: Baseline to Month 48
Use of CGMS (Continuous Glucose Monitor) device measured by the percentage of time during a month that a participant is using their CGM.
Baseline to Month 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diabetes health-related quality of life
Time Frame: Baseline to Month 48
Diabetes Quality of Life Brief Clinical Inventory (Possible range of scores is 15 to 75, with higher scores indicating a negative perspective of the problem's frequency and level of dissatisfaction) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine diabetes health-related quality of life changes over time.
Baseline to Month 48
Diabetes distress changes measured by PAID
Time Frame: Baseline to Month 48
PAID (scale; 0-4) (Possible range of scores is 0 to 100, with higher scores reflecting greater emotional distress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in diabetes distress in adults over time.
Baseline to Month 48
Diabetes distress changes measured by PAID-T
Time Frame: Baseline to Month 48
PAID-T(scale; 1-6) (Possible range of scores is 26-156, with higher scores indicating greater emotional distress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in diabetes distress in teens over time.
Baseline to Month 48
Change in diabetes self-management practices
Time Frame: Baseline to Month 48
SCI-R (scale; never to always) (For scoring, items are averaged and converted to a 0 to 100 point scale, with higher scores indicating higher levels of self-care) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in diabetes self-management practices over time.
Baseline to Month 48

Collaborators and Investigators

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

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Celeste Thomas, MD, University of Chicago

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 (Actual)

November 20, 2020

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB20-1296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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