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This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Intervention arm | Experimental | Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle LibrePro CGM | Device | a professional CGM device will be worn by the participant for up to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1c | Change in A1c will be used to assess glycemic control | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Changes | Data will be collected on what medication changes are made (changes in types of medications and doses) | Baseline to week 12 |
| Glycemic Variability | Data collected by the CGM, such as time-in-therapeutic range, will be evaluated to assess glycemic variability during the 14 day period of wearing the CGM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Sisson, PharmD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Intervention Arm | Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Intervention Arm | Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was only collected on part of the study population. |
| 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 A1c | Change in A1c will be used to assess glycemic control | Posted | Mean | Standard Deviation | percent of hemoglobin | Baseline to week 12 |
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|
6 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 | CGM Intervention Arm | Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Sisson, PharmD | Virginia Commonwealth University | 804-828-8076 | emsisson@vcu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2018 | Dec 18, 2020 | Prot_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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| Baseline to week 12 |
Age data was not collected from all participants.
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Medication Changes | Data will be collected on what medication changes are made (changes in types of medications and doses) | Posted | Mean | Standard Deviation | number of medication changes | Baseline to week 12 |
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|
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| Secondary | Glycemic Variability | Data collected by the CGM, such as time-in-therapeutic range, will be evaluated to assess glycemic variability during the 14 day period of wearing the CGM | Posted | Mean | Standard Deviation | percent time in range | Baseline to week 12 |
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| 0 |
| 14 |
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| 14 |
| 0 |
| 14 |
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| Title | Measurements |
|---|---|
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