NCT06899191

Brief Summary

The goal of this clinical trial is to improve the processes of Type 2 Diabetes (T2D) care coordination and treatment in the emergency department (ED) by utilizing clinical decision support mechanisms in the electronic health record (EHR). The main question is whether electronic prompts triggered by hyperglycemia and elevated A1c results in providers providing earlier treatments and faster time to subsequent primary care appointment and greater reduction in hemoglobin A1c (HA1c). ED clinicians will receive alerts called Our Practice Advisories (OPA's) through the EPIC EHR. The 1st OPA triggers when a random point-of-care (POC) glucose is ≥250 mg/dL, prompting a suggested additional HA1c order. A 2nd OPA triggers if the resulting HA1c is ≥10%, prompting consideration of further care coordination in the Observation Unit. Investigators will compare the outcomes post-intervention compared to pre-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 21, 2025

Last Update Submit

April 26, 2026

Conditions

Keywords

Type 2 DiabetesElectronic PromptEmergency Department DiabetesPractice Advisory

Outcome Measures

Primary Outcomes (2)

  • Care Coordination: Follow-Up Care

    % Patients achieving: A T2D-related appointment within 4 weeks

    From date of ED encounter until 4 weeks after

  • Physiologic Response

    % Patients achieving: HbA1c 1% reduction in 3 months

    From date of ED encounter to 4 months after

Secondary Outcomes (11)

  • Care Coordination: Disposition

    Within 1 day of ED encounter date

  • Care Coordination: Length of stay

    1 day

  • Care Coordination: Insurance

    Within 3 weeks of ED encounter

  • Care Coordination: Medication Prescription

    3 days

  • Care Coordination: Medication Change

    3 days

  • +6 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

All ED providers exposed to electronic alerts

Diagnostic Test: Hemoglobin A1cBehavioral: Observation Unit

Interventions

Hemoglobin A1cDIAGNOSTIC_TEST

Prompt to order A1c

Intervention

Electronic prompt nudging ED provider to consider admitting patient to the Observation Unit for care coordination and more aggressive glycemic control

Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate hyperglycemia, (glucose ≥250 mg/dL)
  • Patients who arrive in the emergency department
  • Not pregnant or peri-partum
  • Not SARS-COV-2 PCR positive in past 7 days

You may not qualify if:

  • Diabetic ketoacidosis (pH \< 7.20, HCO3 \< 15, AG \> 25)
  • Diabetic foot ulcer or skin complications
  • Hyperglycemic hyperosmolar state with neurologic impairment
  • Patients who leave against medical advice (AMA), elope from the ED, or are transferred to another facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers, Robert Wood Johnson Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (14)

  • Yan JW, Vujcic B, Le BN, Van Aarsen K, Chen T, Halane F, Clemens KK. Predictors of 30-day recurrent emergency department visits for hyperglycemia in patients with types 1 and 2 diabetes: a population-based cohort study. CJEM. 2024 Jun;26(6):424-430. doi: 10.1007/s43678-024-00686-4. Epub 2024 Apr 18.

    PMID: 38635005BACKGROUND
  • Magee MF, Nassar C. Hemoglobin A1c testing in an emergency department. J Diabetes Sci Technol. 2011 Nov 1;5(6):1437-43. doi: 10.1177/193229681100500615.

    PMID: 22226261BACKGROUND
  • Magee MF, Nassar CM, Copeland J, Fokar A, Sharretts JM, Dubin JS, Smith MS. Synergy to reduce emergency department visits for uncontrolled hyperglycemia. Diabetes Educ. 2013 May-Jun;39(3):354-64. doi: 10.1177/0145721713484593. Epub 2013 Apr 22.

    PMID: 23610182BACKGROUND
  • King WM 4th, McDermott MT, Trujillo JM. Initial management of severe hyperglycemia in patients with type 2 diabetes: an observational study. Diabetes Ther. 2013 Dec;4(2):375-84. doi: 10.1007/s13300-013-0036-9. Epub 2013 Aug 16.

    PMID: 23949906BACKGROUND
  • Ginde AA, Delaney KE, Pallin DJ, Camargo CA Jr. Multicenter survey of emergency physician management and referral for hyperglycemia. J Emerg Med. 2010 Feb;38(2):264-70. doi: 10.1016/j.jemermed.2007.11.088. Epub 2008 Jul 26.

    PMID: 18657930BACKGROUND
  • Gale J, Varndell W, James S, Perry L. Unscheduled emergency department presentations with diabetes: Identifying high risk characteristics. Australas Emerg Care. 2023 Sep;26(3):205-210. doi: 10.1016/j.auec.2022.12.001. Epub 2022 Dec 15.

    PMID: 36528482BACKGROUND
  • Driver BE, Olives TD, Prekker ME, Miner JR, Klein LR. The Association of Emergency Department Treatments for Hyperglycemia with Glucose Reduction and Emergency Department Length of Stay. J Emerg Med. 2017 Dec;53(6):791-797. doi: 10.1016/j.jemermed.2017.08.068. Epub 2017 Oct 6.

    PMID: 28993036BACKGROUND
  • Driver BE, Olives TD, Bischof JE, Salmen MR, Miner JR. Discharge Glucose Is Not Associated With Short-Term Adverse Outcomes in Emergency Department Patients With Moderate to Severe Hyperglycemia. Ann Emerg Med. 2016 Dec;68(6):697-705.e3. doi: 10.1016/j.annemergmed.2016.04.057. Epub 2016 Jun 25.

    PMID: 27353284BACKGROUND
  • Driver BE, Klein LR, Cole JB, Prekker ME, Fagerstrom ET, Miner JR. Comparison of two glycemic discharge goals in ED patients with hyperglycemia, a randomized trial. Am J Emerg Med. 2019 Jul;37(7):1295-1300. doi: 10.1016/j.ajem.2018.09.053. Epub 2018 Oct 5.

    PMID: 30316635BACKGROUND
  • Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.

    PMID: 36151309BACKGROUND
  • Crawford AL, Laiteerapong N. Type 2 Diabetes. Ann Intern Med. 2024 Jun;177(6):ITC81-ITC96. doi: 10.7326/AITC202406180. Epub 2024 Jun 11.

    PMID: 38857502BACKGROUND
  • Charfen MA, Ipp E, Kaji AH, Saleh T, Qazi MF, Lewis RJ. Detection of undiagnosed diabetes and prediabetic states in high-risk emergency department patients. Acad Emerg Med. 2009 May;16(5):394-402. doi: 10.1111/j.1553-2712.2009.00374.x. Epub 2009 Mar 16.

    PMID: 19302369BACKGROUND
  • Bowen ME, Xuan L, Lingvay I, Halm EA. Random blood glucose: a robust risk factor for type 2 diabetes. J Clin Endocrinol Metab. 2015 Apr;100(4):1503-10. doi: 10.1210/jc.2014-4116. Epub 2015 Feb 4.

    PMID: 25650899BACKGROUND
  • American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.

    PMID: 38078589BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HyperglycemiaDiabetes Mellitus, Type 1

Interventions

Clinical Observation Units

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 27, 2025

Study Start

March 30, 2025

Primary Completion

April 1, 2026

Study Completion

April 26, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Subject data stored on RedCap can be extracted with deidentified information for data sharing.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Until 1 year after study
Access Criteria
Only the Principal Investigator, PP, will have access
More information

Locations