GOOD-ER: Glycemic Optimization On Discharge From the Emergency Room

Sponsor
Mark O'Connor (Other)
Overall Status
Recruiting
CT.gov ID
NCT05197829
Collaborator
(none)
200
1
2
16.8
11.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous Glucose Monitoring
  • Other: Care Coordination
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Glycemic Optimization On Discharge From the Emergency Room
Actual Study Start Date :
Jan 5, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Continuous Glucose Monitoring

Device: Continuous Glucose Monitoring
Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.

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

Active Comparator: Care Coordination

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

Outcome Measures

Primary Outcome Measures

  1. Diabetes Distress [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.

  2. Outpatient Clinic Attendance Rate [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.

  3. Quality of Life [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.

Secondary Outcome Measures

  1. Number of Patients with Repeat Emergency Utilization [6 months]

    This metric will include repeat emergency room visits and emergency medical services calls.

  2. Hemoglobin A1c Values [3 and 6 Months]

    Hemoglobin A1c values drawn as part of routine care will be recorded. The 3-month value will be the A1c value checked closest to 3 months after the initial emergency visit (up to a month before or after the 3-month date) and the 6-month value will be the closest A1c value to 6 months, give or take up to 2 months.

  3. Hospitalizations [6 Months]

    We will record the number of hospitalizations over 6 months following the initial emergency room visit.

  4. Outpatient Visits for which the CGM Data Changed Management [2-3 Weeks]

    For each patient in the CGM arm, the provider will complete a survey at the time of the initial outpatient follow-up appointment.

  5. Time In Range [Up to 14 days after the initial emergency visit]

    For participants in the continuous glucose monitoring arm, we will measure the percentage of time spent with a blood sugar level between 70 and 180 mg/dl.

  6. Days Sensor Is Worn [Up to 14 days after the initial emergency visit]

    For participants in the continuous glucose monitoring arm, we will measure the number of days the sensor was worn.

  7. Number of Sensor Checks per Day [Up to 14 days after the initial emergency visit]

    For participants in the continuous glucose monitoring arm, we will measure the number of times per day the sensor was used to check a blood sugar level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UMass Memorial Medical Center Worcester Massachusetts United States 01655

Sponsors and Collaborators

  • Mark O'Connor

Investigators

  • Principal Investigator: Mark J O'Connor, MD, University of Massachusetts, Worcester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark O'Connor, Assistant Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT05197829
Other Study ID Numbers:
  • H00023559
First Posted:
Jan 20, 2022
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022