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

NCT06899984 | Active Not Recruiting

• 1 other identifier: IRB20-1296
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Change in CGM Utilization

  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 Outcomes (4)

• Change in diabetes health-related quality of life

  Baseline to Month 48

• Diabetes distress changes measured by PAID

  Baseline to Month 48

• Diabetes distress changes measured by PAID-T

  Baseline to Month 48

• Change in diabetes self-management practices

  Baseline to Month 48

Study Arms (1)

Patient Navigator

EXPERIMENTAL

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

Behavioral: Patient Navigator

Interventions

Patient Navigator BEHAVIORAL

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

Patient Navigator

Eligibility Criteria

• Age: 14 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Celeste Thomas, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 28, 2025
• Study Start: November 20, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)