Clinical trial NCT06899984: Using Technology to Address Disparities and Promote Healthcare Equity in Type 1 Diabetes Registry
Official title: Using Technology to Address Disparities and Promote Healthcare Equity in Type 1 Diabetes Registry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in CGM Utilization
timeFrame: Baseline to Month 48
Secondary outcomes:
measure: Change in diabetes health-related quality of life
timeFrame: Baseline to Month 48
measure: Diabetes distress changes measured by PAID
timeFrame: Baseline to Month 48
measure: Diabetes distress changes measured by PAID-T
timeFrame: Baseline to Month 48
measure: Change in diabetes self-management practices
timeFrame: Baseline to Month 48
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Celeste Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: