Diabetes Mellitus
Conditions
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.
Interventions
OTHERCare Coordination
All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
DEVICEContinuous Glucose Monitoring
Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.
Sponsors
Mark O'Connor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Patients With Repeat Emergency Utilization | 6 months | This metric will include repeat emergency room visits and emergency medical services calls. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitoring Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.
Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments. | 16 |
| Care Coordination Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Care Coordination | Total | Continuous Glucose Monitoring |
|---|---|---|---|
| Age, Continuous | 60 years | 58 years | 56 years |
| Baseline A1c | 10.6 percentage of glycated hemoglobin STANDARD_DEVIATION 3 | 11.1 percentage of glycated hemoglobin STANDARD_DEVIATION 2.8 | 11.5 percentage of glycated hemoglobin STANDARD_DEVIATION 2.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| New Diagnosis | 3 Participants | 13 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 18 Participants | 9 Participants |
| Region of Enrollment United States | 14 participants | 30 participants | 16 participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
| Type 2 Diabetes | 14 Participants | 29 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
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).
Time frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Population: We analyzed data for patients who completed both the intake survey and the follow-up survey. Some participants never completed the follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Change in Diabetes Distress | 0 units on a scale | Standard Deviation 1.1 |
| Care Coordination | Change in Diabetes Distress | 0.5 units on a scale | Standard Deviation 1 |
Primary
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).
Time frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Population: We analyzed data for patients who completed both the intake survey and the follow-up survey. Some participants never completed the follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Change in the Problem Areas in Diabetes Score | 0 units on a scale | Standard Deviation 5.8 |
| Care Coordination | Change in the Problem Areas in Diabetes Score | 2.3 units on a scale | Standard Deviation 3.2 |
Primary
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.
Time frame: Follow-up visits will generally occur within 2 or 3 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Outpatient Clinic Attendance Rate | 12 Participants |
| Care Coordination | Outpatient Clinic Attendance Rate | 9 Participants |
Secondary
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.
Time frame: 6 Months
Population: We analyzed data for participants who had both a baseline A1c and a follow-up A1c, regardless of whether they attended clinic follow-up visits or not. Some participants did not have follow-up A1c values and were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Change in Hemoglobin A1c | 5.2 percentage of glycated hemoglobin | Standard Deviation 3.3 |
| Care Coordination | Change in Hemoglobin A1c | 2.4 percentage of glycated hemoglobin | Standard Deviation 3.4 |
Secondary
Number of Patients With Repeat Emergency Utilization
This metric will include repeat emergency room visits and emergency medical services calls.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Number of Patients With Repeat Emergency Utilization | 5 Participants |
| Care Coordination | Number of Patients With Repeat Emergency Utilization | 7 Participants |
Secondary
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.
Time frame: Up to 14 days after the initial emergency visit
Population: We analyzed data for all participants who wore the CGM and returned to clinic with data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring | Number of Sensor Checks Per Day | 15 Scans per day |
Secondary
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 frame: 2-3 Weeks
Population: We analyzed data for all provider surveys received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Outpatient Visits for Which the CGM Data Changed Management | 7 Participants |
Secondary
Percentage Time CGM Active
For participants in the continuous glucose monitoring arm, we will measure the amount of time the sensor was worn.
Time frame: Up to 14 days after the initial emergency visit
Population: We analyzed data for all participants who wore the CGM and returned to clinic with data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring | Percentage Time CGM Active | 73 Percentage of time |
Secondary
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.
Time frame: Up to 14 days after the initial emergency visit
Population: We analyzed data for all participants who wore the CGM and returned to clinic with data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring | Time In Range | 37 Percentage of time |