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Completed

NCT Number: NCT05197829

Glycemic Optimization On Discharge From the Emergency Room

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring

Device

Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.

Care Coordination

Other

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

Primary outcomes

  1. 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).

  2. 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.

  3. 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

  1. Number of Patients With Repeat Emergency Utilization

    Time frame: 6 months

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

  2. Change in Hemoglobin A1c

    Time frame: 6 Months

    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.

  3. Outpatient Visits for Which the CGM Data Changed Management

    Time frame: 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.

  4. Time In Range

    Time frame: 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.

  5. Percentage Time CGM Active

    Time frame: Up to 14 days after the initial emergency visit

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

  6. Number of Sensor Checks Per Day

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mark O'Connor

Other

Registry information

Acronym: GOOD-ER

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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