Glycemic Optimization On Discharge From the Emergency Room (GOOD-ER)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitoring; Other: Care Coordination

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Patients With Repeat Emergency Utilization	This metric will include repeat emergency room visits and emergency medical services calls.	6 months
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: H00023559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual-level data underlying published results will be shared with other researchers at the discretion of the principal investigator in accordance with local and institutional policies.

Drug and device information, study documents

• 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