search
Back to results

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

Primary Purpose

Diabetes Mellitus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitoring
Care Coordination
Sponsored by
Mark O'Connor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UMass Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous Glucose Monitoring

Care Coordination

Arm Description

Outcomes

Primary Outcome Measures

Diabetes Distress
Diabetes-related distress will be measured via the 17-question Diabetes Distress Scale (DDS). A higher score indicates more diabetes-related distress.
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.
Problem Areas in Diabetes
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

Number of Patients with Repeat Emergency Utilization
This metric will include repeat emergency room visits and emergency medical services calls.
Hemoglobin A1c Values
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.
Hospitalizations
We will record the number of hospitalizations over 6 months following the initial emergency room visit.
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.
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.
Days Sensor Is Worn
For participants in the continuous glucose monitoring arm, we will measure the number of days the sensor was worn.
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.

Full Information

First Posted
December 13, 2021
Last Updated
May 5, 2023
Sponsor
Mark O'Connor
search

1. Study Identification

Unique Protocol Identification Number
NCT05197829
Brief Title
Glycemic Optimization On Discharge From the Emergency Room
Acronym
GOOD-ER
Official Title
Glycemic Optimization On Discharge From the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark O'Connor

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Glucose Monitoring
Arm Type
Experimental
Arm Title
Care Coordination
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Description
Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.
Intervention Type
Other
Intervention Name(s)
Care Coordination
Intervention Description
All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Primary Outcome Measure Information:
Title
Diabetes Distress
Description
Diabetes-related distress will be measured via the 17-question Diabetes Distress Scale (DDS). A higher score indicates more diabetes-related distress.
Time Frame
Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Title
Outpatient Clinic Attendance Rate
Description
This outcome will measure whether or not each participant attends a subspecialty follow-up appointment as recommended by the emergency room care team.
Time Frame
Follow-up visits will generally occur within 2 or 3 weeks
Title
Problem Areas in Diabetes
Description
Each participant will fill out the five-question Problem Areas In Diabetes (PAID5) scale. A higher score indicates worse quality of life.
Time Frame
Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Secondary Outcome Measure Information:
Title
Number of Patients with Repeat Emergency Utilization
Description
This metric will include repeat emergency room visits and emergency medical services calls.
Time Frame
6 months
Title
Hemoglobin A1c Values
Description
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.
Time Frame
3 and 6 Months
Title
Hospitalizations
Description
We will record the number of hospitalizations over 6 months following the initial emergency room visit.
Time Frame
6 Months
Title
Outpatient Visits for which the CGM Data Changed Management
Description
For each patient in the CGM arm, the provider will complete a survey at the time of the initial outpatient follow-up appointment.
Time Frame
2-3 Weeks
Title
Time In Range
Description
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.
Time Frame
Up to 14 days after the initial emergency visit
Title
Days Sensor Is Worn
Description
For participants in the continuous glucose monitoring arm, we will measure the number of days the sensor was worn.
Time Frame
Up to 14 days after the initial emergency visit
Title
Number of Sensor Checks per Day
Description
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.
Time Frame
Up to 14 days after the initial emergency visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J O'Connor, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Glycemic Optimization On Discharge From the Emergency Room

We'll reach out to this number within 24 hrs