Glycemic Optimization On Discharge From the Emergency Room

Study Overview
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Brief Summary
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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.

Official Title
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Glycemic Optimization On Discharge From the Emergency Room

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose Monitoring
* Other: Care Coordination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring<br> | Device: Continuous Glucose Monitoring<br>* Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.<br>Other: Care Coordination<br>* All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.<br>|
| Active Comparator: Care Coordination<br> | Other: Care Coordination<br>* All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Distress | Diabetes-related distress will be measured via the 17-question Diabetes Distress Scale (DDS). A higher score indicates more diabetes-related distress. | Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks) | 
| 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 | 
| 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. | Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Repeat Emergency Utilization | This metric will include repeat emergency room visits and emergency medical services calls. | 6 months | 
| 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. | 3 and 6 Months | 
| Hospitalizations | We will record the number of hospitalizations over 6 months following the initial emergency room visit. | 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 | 
| 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 | 
| Days Sensor Is Worn | For participants in the continuous glucose monitoring arm, we will measure the number of days 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 |