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

The University of Chicago

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Patient Navigator

Study type: Interventional

Funder types: Other

Identifiers

NCT06899984

IRB20-1296

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 14 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Patient Navigator

Experimental group

Description:

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

Treatment:

Behavioral: Patient Navigator