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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring | Experimental |
| |
| Care Coordination | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| 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). | Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J O'Connor, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Care Coordination | Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | We analyzed data for patients who completed both the intake survey and the follow-up survey. Some participants never completed the follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark O'Connor | University of Massachusetts Chan Medical School | 508-334-1000 | mark.oconnor2@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2023 | Feb 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Care Coordination | Other | All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments. |
|
| 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 |
| Percentage Time CGM Active | For participants in the continuous glucose monitoring arm, we will measure the amount of time 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 |
| Care Coordination |
Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type 2 Diabetes | Count of Participants | Participants |
|
| New Diagnosis | Count of Participants | Participants |
|
| Baseline A1c | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| OG001 | Care Coordination | Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments. |
|
|
| 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. | Posted | Count of Participants | Participants | Follow-up visits will generally occur within 2 or 3 weeks |
|
|
|
| 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). | We analyzed data for patients who completed both the intake survey and the follow-up survey. Some participants never completed the follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks) |
|
|
|
| Secondary | Number of Patients With Repeat Emergency Utilization | This metric will include repeat emergency room visits and emergency medical services calls. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 6 Months |
|
|
|
| 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. | We analyzed data for all provider surveys received. | Posted | Count of Participants | Participants | 2-3 Weeks |
|
|
|
| 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. | We analyzed data for all participants who wore the CGM and returned to clinic with data. | Posted | Mean | Full Range | Percentage of time | Up to 14 days after the initial emergency visit |
|
|
|
| Secondary | Percentage Time CGM Active | For participants in the continuous glucose monitoring arm, we will measure the amount of time the sensor was worn. | We analyzed data for all participants who wore the CGM and returned to clinic with data. | Posted | Mean | Full Range | Percentage of time | Up to 14 days after the initial emergency visit |
|
|
|
| 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. | We analyzed data for all participants who wore the CGM and returned to clinic with data. | Posted | Mean | Full Range | Scans per day | Up to 14 days after the initial emergency visit |
|
|
|
| 1 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Care Coordination | Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |