Recruiting

Observational Study

Sponsor:

T1D Exchange, United States

Code:

NCT06931275

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Interventions

EMR-based BPA model

Placebo (EMR-based without BPA model)

Study Details

Brief summary:

The overall goal of the study is to create a standardized, stakeholder-informed system within EMRs, that will enable an equitable and regular prescription and documentation of advanced diabetes technologies. This will reduce racial disparities and generate an understanding of the reasons behind prescription decisions.

The study will highlight the development and implementation an EMR-based Best Practice Advisory (BPA).

The study will answer whether the EMR-based BPA can effectively reduce disparities. Additionally, it will explore why providers may not prescribe advanced diabetes technologies.

Patients will also be surveyed to understand their perspectives on developing the EMR-based BPA.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT06931275

Start date

Aug 13, 2024

Status verified date

Jun, 2024

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Age ≥ 2 years with an EMR diagnosis of T1D for at least 6 months at baseline and receiving care at one of six intervention centers or a matched control at another T1DX-QI center.

Inclusion Criteria:

  • non-Hispanic Black and Hispanic individuals

Exclusion Criteria:

  • PwT1D with evidence of use of AID at baseline

Study Design

Enrollment

1178 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: ADT use following Best Practice Advisory among non- Hispanic Black and Hispanic Patients with T1D

ADT use following a BPA intervention among non-Hispanic Black and Hispanic PwT1D receiving care at 6 T1DX-QI centers will be assessed. The EMR-based BPA will be designed to recommend ADT prescription to patients not already using some type of ADT using a rule-based algorithm. ADT will include CGM, insulin pumps, and AID systems. We will work with each of the 6 centers to implement the BPA as part of the Epic EMR. The function will generate a BPA if patient is not utilizing a CGM or pump/AID. If the patient is not on a CGM, pump or AID system (if already using CGM and pump), the BPA will suggest discussing and/or prescribing CGM (or pump/AID) to the provider. The provider will answer in the affirmative or say, "not discussed" or "patient declined." If the provider chooses to opt out of prescribing, they will be forced to provide a reason for not prescribing to advance the screen. Providers in each intervention center will be trained on the BPA process prior to implementation.

placebo comparator: ADT use among non- Hispanic Black and Hispanic Patients with T1D

The arm will comprise of a matched control non-Hispanic Black and Hispanic PwT1D receiving care at a center over a 12-month period. Participants will be matched on the basis of Age categories, biological sex, Insurance status, Area deprivation index, Baseline Technology use, Duration of T1D bins, and Baseline HbA1c.

Interventions

EMR-based BPA model

Advanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based BPA implementation at six centers.

Placebo (EMR-based without BPA model)

Advanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based system without BPA at the implementation at six centers.

Primary outcome measure

  • Progression of Advanced Diabetes Technology use [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

T1D Exchange

Recruiting

Boston, Massachusetts, United States, 02110

Contacts

Principal Investigator:

Osagie Ebekozien, MD, MPH

More Information

Sponsor

T1D Exchange, United States

Last update posted

Apr 17, 2025

Last verified

Jun, 2024

Keywords

  • Advanced Diabetes Technologies,
  • Automated Insulin Delivery
  • Best Practice Advisories
  • Continuous Glucose Monitoring.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by T1D Exchange, United States on 2025-04-17.