Glycemic Optimization On Discharge From the Emergency Room

Diabetes Mellitus Clinical Trial

— GOOD-ER  

Official title:

Glycemic Optimization On Discharge From the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197829
• Other study ID #: H00023559
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: January 5, 2024

Study information

• Verified date: March 2024
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Emergencies

Intervention

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.

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mark O'Connor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diabetes Distress	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).	Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Primary	Outpatient Clinic Attendance Rate	This outcome will measure whether or not each participant attends a subspecialty follow-up appointment as recommended by the emergency room care team.	Follow-up visits will generally occur within 2 or 3 weeks
Primary	Change in the Problem Areas in Diabetes Score	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).	Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Secondary	Number of Patients With Repeat Emergency Utilization	This metric will include repeat emergency room visits and emergency medical services calls.	6 months
Secondary	Change in Hemoglobin A1c	Hemoglobin A1c values drawn as part of routine care will be recorded. A positive value indicates that the hemoglobin A1c was lower at follow up than it was at baseline.	6 Months
Secondary	Outpatient Visits for Which the CGM Data Changed Management	For each patient in the CGM arm, the provider will complete a survey at the time of the initial outpatient follow-up appointment.	2-3 Weeks
Secondary	Time In Range	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.	Up to 14 days after the initial emergency visit
Secondary	Percentage Time CGM Active	For participants in the continuous glucose monitoring arm, we will measure the amount of time the sensor was worn.	Up to 14 days after the initial emergency visit
Secondary	Number of Sensor Checks Per Day	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.	Up to 14 days after the initial emergency visit