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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
Subjects who have an Islet Transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. It is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. As a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Experimental | Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Other | Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Time in Range 70-180 mg/dL by CGM | Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL | 28-90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Time in Range <70 mg/dL by CGM | Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL | 28-90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue A Brown, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Monitor (CGM) | Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Glucose Monitor (CGM) | Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months. |
| 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 | Percentage Time in Range 70-180 mg/dL by CGM | Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL | Participants with available CGM data for analysis. | Posted | Mean | Standard Deviation | percentage of CGM readings 70-180mg/dL | 28-90 days |
|
|
During use of study equipment up to 3 months
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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 Monitor (CGM) | Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sue Brown, MD | University of Virginia | 4349820602 | sab2f@virginia.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 | Apr 5, 2018 | Jul 11, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 27, 2018 | Jul 11, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hemoglobin A1c | Available data at baseline. | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage Time in Range <70 mg/dL by CGM | Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL | Posted | Mean | Standard Deviation | percentage of CGM readings <70mg/dL | 28-90 days |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |