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

NCT ID: NCT06899984

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2027-03-31

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient Navigator

Patient Navigator will provide additional support to participants using their standard of care CGM device.

Group Type: EXPERIMENTAL

Patient Navigator

Intervention Type: BEHAVIORAL

Patient Navigator will provide additional support to participants using their standard of care CGM device.

Interventions

Patient Navigator

Patient Navigator will provide additional support to participants using their standard of care CGM device.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celeste Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB20-1296

Identifier Type: -

Identifier Source: org_study_id