Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06899984

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigator

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: EquiT1D

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.