Glycemic Optimization On Discharge From the Emergency Room
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Continuous Glucose MonitoringOther: Care Coordination
- Registration Number
- NCT05197829
- Lead Sponsor
- Mark O'Connor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous Glucose Monitoring Continuous Glucose Monitoring - Continuous Glucose Monitoring Care Coordination - Care Coordination Care Coordination -
- Primary Outcome Measures
Name Time Method Change in Diabetes Distress 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).
Outpatient Clinic Attendance Rate 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.
Change in the Problem Areas in Diabetes Score 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 Outcome Measures
Name Time Method Time In Range 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.
Percentage Time CGM Active 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.
Number of Sensor Checks Per Day 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.
Number of Patients With Repeat Emergency Utilization 6 months This metric will include repeat emergency room visits and emergency medical services calls.
Change in Hemoglobin A1c 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.
Outpatient Visits for Which the CGM Data Changed Management 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.
Trial Locations
- Locations (1)
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States