NCT06931275

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,178

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Aug 2024Jul 2027

Study Start

First participant enrolled

August 13, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

April 17, 2025

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

September 9, 2024

Last Update Submit

April 15, 2025

Conditions

Keywords

Advanced Diabetes Technologies,Automated Insulin DeliveryBest Practice AdvisoriesContinuous Glucose Monitoring.

Outcome Measures

Primary Outcomes (1)

  • Progression of Advanced Diabetes Technology use

    Defined as positive for an individual if: • MDI/smartpen + no CGM begins using CGM * MDI/smartpen + CGM begins using insulin pump * Insulin pump + no CGM begins using CGM * Insulin pump + CGM (without AID) begins using AID

    12 months

Study Arms (2)

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

EXPERIMENTAL

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.

Other: EMR-based BPA model

ADT use among non- Hispanic Black and Hispanic Patients with T1D

PLACEBO COMPARATOR

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.

Behavioral: Placebo (EMR-based without BPA model)

Interventions

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

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

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.

ADT use among non- Hispanic Black and Hispanic Patients with T1D

Eligibility Criteria

Age2 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • non-Hispanic Black and Hispanic individuals

You may not qualify if:

  • PwT1D with evidence of use of AID at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

T1D Exchange

Boston, Massachusetts, 02110, United States

RECRUITING

T1D Exchange

Boston, Massachusetts, 02111, United States

NOT YET RECRUITING

Related Publications (4)

  • Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ. 2005 Apr 2;330(7494):765. doi: 10.1136/bmj.38398.500764.8F. Epub 2005 Mar 14.

    PMID: 15767266BACKGROUND
  • Flores EJ, Jue JJ, Giradi G, Schoelles K, Mull NK, Umscheid CA. AHRQ EPC Series on Improving Translation of Evidence: Use of a Clinical Pathway for C. Difficile Treatment to Facilitate the Translation of Research Findings into Practice. Jt Comm J Qual Patient Saf. 2019 Dec;45(12):822-828. doi: 10.1016/j.jcjq.2019.10.002. Epub 2019 Oct 28.

    PMID: 31672660BACKGROUND
  • Ebekozien O, Mungmode A, Buckingham D, Greenfield M, Talib R, Steenkamp D, Haw JS, Odugbesan O, Harris M, Mathias P, Dickinson JK, Agarwal S. Achieving Equity in Diabetes Research: Borrowing From the Field of Quality Improvement Using a Practical Framework and Improvement Tools. Diabetes Spectr. 2022 Summer;35(3):304-312. doi: 10.2337/dsi22-0002. Epub 2022 Aug 15.

    PMID: 36072814BACKGROUND
  • Mathioudakis N, Wolf R, Choudhary A, Davis G, Gallagher MP, Gupta M, Kamboj M, Rioles N, Ospelt E, Thapa S, Weinstock RS, Wright T, Ebekozien O. 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. JMIR Res Protoc. 2025 May 28;14:e71038. doi: 10.2196/71038.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Osagie Ebekozien

    T1DExchange

    PRINCIPAL INVESTIGATOR
  • Nestoras Mathioudakis

    Johns Hopkins University

    STUDY DIRECTOR
  • Risa Wolf

    Johns Hopkins Pediatrics

    STUDY DIRECTOR

Central Study Contacts

Osagie Ebekozien, MD

CONTACT

Trevon Wright, MHA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,

Study Record Dates

First Submitted

September 9, 2024

First Posted

April 17, 2025

Study Start

August 13, 2024

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

April 17, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

There will be no Individual Participant data collection.

Locations