Implementation and Evaluation of a Best Practice Advisory to Reduce Inequities in Technology Use for People With Type 1 Diabetes: Protocol for a Mixed Methods, Nonrandomized Controlled Trial

Abstract

Background: Continuous advancements in diabetes technologies have improved self-management for people with type 1 diabetes. Continuous glucose monitoring and automated insulin delivery systems have enhanced the quality of life and glycemic outcomes while reducing severe hypoglycemia and diabetes ketoacidosis hospitalizations. Despite these benefits, racial inequities in the use of advanced diabetes technology (ADT) persist.

Objective: This study aims to develop and evaluate a best practice advisory (BPA) within the electronic medical record (EMR) to reduce racial and ethnic disparities in ADT use. We hypothesize that an EMR-based BPA designed to standardize the prescribing of ADTs will minimize racial and ethnic disparities in ADT adoption or progression in use among pediatric and adult people with type 1 diabetes.

Methods: The Best Practice Advisories to Reduce Inequities in Technology Use (BPA-TECH) study will use a nonrandomized matched pair intervention design. Phase 1 will use qualitative methods to develop and refine the BPA, including focus groups and surveys of health care providers and people with type 1 diabetes or their caregivers. Phase 2 will evaluate the effectiveness of the BPA through a controlled before-after study of people with type 1 diabetes seen at 7 T1D Exchange Quality Improvement Collaborative (T1DX-QI) centers, with control people with type 1 diabetes matched from nonintervention T1DX-QI centers. The baseline and postintervention periods will be the 12 months before and 12 months after deployment of the BPA at the intervention centers, respectively. Eligibility criteria include people with type 1 diabetes aged ≥2 years with an EMR diagnosis of T1D during the baseline period. The primary outcome is the progression in ADT use from the baseline to postintervention periods.

Results: This 3-year study began in July 2024, with data collection from key stakeholders for phase 1 qualitative research beginning in August 2024. For phase 2, we estimate approximately 3000 eligible non-Hispanic Black and Hispanic people with type 1 diabetes at the intervention centers and 15,000 matched controls. Data on ADT use, glycated hemoglobin (HbA_1c), severe hypoglycemic events, and diabetes ketoacidosis events will be collected via the T1DX-QI coordinating center. The study is powered to detect a between-group difference of 15% in the proportion of patients in the intervention and control groups in meeting the primary endpoint. We anticipate the completion of this study by May 2027.

Conclusions: The BPA-TECH study aims to leverage health IT to address racial and ethnic disparities in ADT use among people with type 1 diabetes. By standardizing the approach to ADT prescribing for people with type 1 diabetes, the BPA-TECH has the potential to promote equity in diabetes management and improve clinical outcomes. The outcomes of this study will inform future efforts to reduce health care disparities.

Trial registration: ClinicalTrials.gov NCT06931275; https://clinicaltrials.gov/search?term=NCT06931275.

International registered report identifier (irrid): DERR1-10.2196/71038.

Keywords: automated insulin delivery system; best practice advisory; clinical decision support; continuous glucose monitor; disparities; equity; insulin pump; practice advisory; type 1 diabetes.