Glycemic Optimization On Discharge From the Emergency Room

NCT ID: NCT05197829

Last Updated: 2024-04-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2024-01-05

Brief Summary

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Continuous glucose monitors can help people with diabetes avoid blood sugar levels that are either dangerously high or low. This study evaluates whether continuous glucose monitoring after discharge from the emergency room can help people with type 1 or type 2 diabetes avoid repeat emergency room visits, achieve improved blood sugar control, and feel less distressed about managing their diabetes.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Continuous Glucose Monitoring

Group Type EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type DEVICE

Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.

Care Coordination

Intervention Type OTHER

All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.

Care Coordination

Group Type ACTIVE_COMPARATOR

Care Coordination

Intervention Type OTHER

All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.

Interventions

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Continuous Glucose Monitoring

Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.

Intervention Type DEVICE

Care Coordination

All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Seen in the Emergency Department for hypo- or hyperglycemia
* Either an existing diabetes center patient or a new referral
* Type 1 or type 2 diabetes
* Able to provide informed consent
* Fluent in English or Spanish

Exclusion Criteria

* Current CGM use
* Need for hospital admission
* Upcoming CT or MRI within 2 weeks
* Pregnancy
* Altered mental status
* Not appropriate for diabetes center follow up
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mark O'Connor

OTHER

Sponsor Role lead

Responsible Party

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Mark O'Connor

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark J O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H00023559

Identifier Type: -

Identifier Source: org_study_id

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