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Clinical Trials/NCT05197829
NCT05197829
Completed
Not Applicable

Glycemic Optimization On Discharge From the Emergency Room

Mark O'Connor1 site in 1 country30 target enrollmentJanuary 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Mark O'Connor
Enrollment
30
Locations
1
Primary Endpoint
Change in Diabetes Distress
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2022
End Date
January 5, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mark O'Connor
Responsible Party
Sponsor Investigator
Principal Investigator

Mark O'Connor

Assistant Professor

University of Massachusetts, Worcester

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Diabetes Distress

Time Frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

Diabetes-related distress will be measured via the 17-question Diabetes Distress Scale (DDS). A higher score indicates more diabetes-related distress. The scale ranges from 1 (low distress) to 6 (high distress).

Outpatient Clinic Attendance Rate

Time Frame: Follow-up visits will generally occur within 2 or 3 weeks

This outcome will measure whether or not each participant attends a subspecialty follow-up appointment as recommended by the emergency room care team.

Change in the Problem Areas in Diabetes Score

Time Frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

Each participant will fill out the five-question Problem Areas In Diabetes (PAID5) scale. A higher score indicates worse quality of life. Scores range from 0 (good quality of life) to 20 (poor quality of life).

Secondary Outcomes

  • Time In Range(Up to 14 days after the initial emergency visit)
  • Percentage Time CGM Active(Up to 14 days after the initial emergency visit)
  • Number of Sensor Checks Per Day(Up to 14 days after the initial emergency visit)
  • Number of Patients With Repeat Emergency Utilization(6 months)
  • Change in Hemoglobin A1c(6 Months)
  • Outpatient Visits for Which the CGM Data Changed Management(2-3 Weeks)

Study Sites (1)

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