EMR-Based BPA Model for Type 1 Diabetes

Overseen By Osagie Ebekozien, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: T1D Exchange, United States

Disqualifiers: AID use, others

Compensation: Varies

Number of Visits: Unknown

1178 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve access to advanced diabetes technology, such as continuous glucose monitors and insulin pumps, for non-Hispanic Black and Hispanic individuals with Type 1 Diabetes. An EMR (Electronic Medical Records)-based BPA (Best Practice Alert) model will prompt healthcare providers to discuss and potentially prescribe these technologies, which may reduce racial disparities in care. The trial also seeks to understand why some doctors do not prescribe these technologies. Suitable candidates for this trial are non-Hispanic Black or Hispanic individuals diagnosed with Type 1 Diabetes for at least six months and receiving care at specific centers. As an unphased trial, this study offers a unique opportunity to help reduce healthcare disparities and improve access to essential diabetes technology.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on understanding and improving prescription practices rather than changing your current treatment.

What prior data suggests that this EMR-based BPA model is safe?

Research has shown that the EMR-based BPA model poses no known safety concerns for people. This model, part of electronic medical records, assists doctors in recommending advanced diabetes technologies to patients who have not yet adopted them. It aims to enhance the prescription and documentation of these technologies, particularly for non-Hispanic Black and Hispanic patients with Type 1 Diabetes.

While direct safety data is unavailable, the BPA system is not a physical treatment or medication. It serves as a tool to help healthcare providers make informed decisions. Therefore, no known side effects or risks are associated with using the EMR-based BPA model itself. The safety of the advanced diabetes technologies it recommends, such as continuous glucose monitors (CGMs) or insulin pumps, relies on the existing safety data for those devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMR-based BPA model for Type 1 Diabetes because it leverages technology to enhance personalized care. Unlike standard treatments that rely primarily on insulin management and devices like Continuous Glucose Monitors (CGMs) and insulin pumps, this model uses an electronic medical record system to proactively recommend these technologies to patients who aren't already using them. By integrating a Best Practice Advisory (BPA) into the EMR, healthcare providers receive prompts to discuss or prescribe advanced diabetes technologies (ADTs) tailored to individual needs, potentially improving management outcomes for non-Hispanic Black and Hispanic patients. This approach not only aims to optimize treatment but also seeks to address disparities in diabetes care access and utilization.

What evidence suggests that the EMR-based BPA model is effective for reducing disparities in Type 1 Diabetes care?

Research has shown that electronic medical records (EMRs) with Best Practice Advisories (BPAs) can enhance healthcare by providing timely reminders to doctors and nurses. These reminders ensure patients receive the latest and necessary treatments, which is particularly beneficial for managing Type 1 Diabetes (T1D). This trial will assess the use of a BPA intervention among non-Hispanic Black and Hispanic patients with T1D, aiming to increase prescriptions and use of advanced diabetes tools, such as continuous glucose monitors (CGMs) and insulin pumps. Studies have demonstrated that these tools can significantly improve blood sugar control and reduce complications for people with T1D. The EMR-based BPA system seeks to make this process more consistent, potentially reducing disparities in care among various racial and ethnic groups.

Who Is on the Research Team?

Nestoras Mathioudakis

Principal Investigator

Johns Hopkins University

Osagie Ebekozien

Principal Investigator

T1DExchange

Risa Wolf

Principal Investigator

Johns Hopkins Pediatrics

Are You a Good Fit for This Trial?

This trial is for people with Type 1 Diabetes. It aims to help those who might not be getting the best tech for managing their diabetes due to racial disparities. Participants should be using an electronic medical record (EMR) system, but specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Non-Hispanic Black and Hispanic individuals

I am over 2 years old, diagnosed with Type 1 Diabetes for at least 6 months, and receiving care at a specified center.

Exclusion Criteria

Patients with evidence of use of automated insulin delivery (AID) at baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Development and implementation of an EMR-based Best Practice Advisory (BPA) to standardize the approach for prescribing and documentation of advanced diabetes technologies

12 months

Regular visits as per EMR system updates

Follow-up

Participants are monitored for progression in Advanced Diabetes Technology use and racial disparities in technology prescription

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EMR-based BPA model

Trial Overview The study tests a new EMR-based Best Practice Advisory (BPA) model against a placebo version without BPA features. The goal is to see if this system can make prescribing advanced diabetes technologies more equitable and understand provider prescription behaviors.

How Is the Trial Designed?

Group I: ADT use following Best Practice Advisory among non- Hispanic Black and Hispanic Patients with T1D Experimental Treatment 1 Intervention

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.

Group II: ADT use among non- Hispanic Black and Hispanic Patients with T1D Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

T1D Exchange, United States

Lead Sponsor

Trials

2

Recruited

50,000+

Published Research Related to This Trial

Electronic health records (EHR) can significantly enhance the management of inpatient diabetes by providing clinical decision support tools, such as electronic order sets, which help reduce insulin errors and hypoglycemia rates.

Glycemic management dashboards allow healthcare providers to efficiently monitor blood glucose trends and adjust insulin regimens, improving overall patient care for those with diabetes and hyperglycemia in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Health Record-Based Decision-Making Support in Inpatient Diabetes Management. Gerwer, JE., Bacani, G., Juang, PS., et al.[2022]

Customizing electronic medical records (EMR) with evidence-based guidelines significantly improved the documentation of body mass index (BMI) and the diagnosis of overweight and obesity in children aged 7 to 18 years.

Despite the increase in diagnosis rates following EMR customization, the overall rates of obesity diagnosis still remain lower than the actual prevalence in the community, indicating a need for further improvement in screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood obesity: Can electronic medical records customized with clinical practice guidelines improve screening and diagnosis? Saviñon, C., Taylor, JS., Canty-Mitchell, J., et al.[2018]

The implementation of electronic health records (EHR) has introduced challenges in diabetes care, particularly for patients with limited health literacy and English proficiency, highlighting the need for safer medication prescribing practices.

Recommendations for improving patient safety include adopting standardized medication naming, enhancing communication with pharmacies, and conducting research on EHR practices in safety net healthcare systems to better serve diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Challenges of Electronic Health Records and Diabetes Electronic Prescribing: Implications for Safety Net Care for Diverse Populations. Ratanawongsa, N., Chan, LL., Fouts, MM., et al.[2021]

Citations

1. researchgate.net researchgate.net/scientific-contributions/Emma-Ospelt-2222747441

Emma Ospelt's research works | T1D Exchange and other ... Centers captured patient-reported outcomes including social determinants of health (n = 9), depression (n = 11), transition to adult care (n = 7), and diabetes ...

2. withpower.com withpower.com/trial/phase-diabetes-mellitus-7-2024-8d9fc

EMR-Based BPA Model for Type 1 Diabetes Is the EMR-Based BPA Model for Type 1 Diabetes safe for humans? The research articles do not provide specific safety data for the EMR-Based BPA Model for Type 1 ...

3. researchprotocols.org researchprotocols.org/2025/1/e71038

Implementation and Evaluation of a Best Practice Advisory ... 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 ...

4. trial.medpath.com trial.medpath.com/clinical-trial/0a9288cadd3fac07/nct06931275-best-practice-advisories-type1-diabetes

Best Practice Advisories to Reduce Inequities in Technology ... The study will answer whether the EMR-based BPA can effectively reduce disparities. Additionally, it will explore why providers may not ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12208037/

Validating an Electronic Health Record Algorithm for ... Our primary objective was to validate a best practice advisory (BPA) screening algorithm informed by the ADA guidelines to identify patients eligible for ...