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| Name | Class |
|---|---|
| American Society of Health-System Pharmacists | OTHER |
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The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes.
The objective of this research is to determine the effectiveness of a targeted intervention that integrates continuous glucose monitors and pharmacist-led comprehensive medication management services among uninsured adult patients with poor glycemic control on basal insulin, specifically focusing on Black and Hispanic populations. This pilot study is designed to help justify implementing this intervention on a larger scale within our healthcare system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitor | Experimental | Patients in the intervention arm will receive a continuous glucose monitor in addition to usual care. These patients will be scheduled at least once monthly for clinical pharmacy visits. |
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| Usual Care | Active Comparator | Patients in the usual care arm will have routine physician office visits every 3 months if HbA1c outside goal or every 6 months if HbA1c within goal. Medication regimens will be managed by physicians, nurse practitioners, and physician assistants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Behavioral | Patient will be provided a continuous glucose monitor. Pharmacist will provide information regarding how to best manage type 2 diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Change in percentage for Hemoglobin A1c. Normal range for hemoglobin A1c is 4.2%-14%. A low level indicates no diabetes and a high level indicates uncontrolled diabetes. | Baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Appraisal of Diabetes Scale | Health-related quality of life will be measured using Appraisal of Diabetes scale (ADS). The ADS is a diabetes-specific quality of life instrument. It consists of 7 items on how diabetes affects the respondent. The score of each item ranges from 0 to 5 with 0 representing the least effect of diabetes and 5 the greatest effect of diabetes. The total score is calculated by summing the scores of individual items. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Larson, PharmD, CPP | Myers Park Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Myers Park Internal Medicine Clinic | Charlotte | North Carolina | 28207 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2024 | Oct 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care | Behavioral | Routine physician office visits and hemoglobinA1c every 3 for those with HbA1c outside goal and every 6 months for those with HbA1c within goal. Medication regimens managed by physicians, nurse practitioners, and physician assistants. Patients are sent reminders on the phone prior to their visits or when they are due for a visit or any physical examination. |
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| Baseline, 1 Month Post Intervention |
| Diabetes Treatment Satisfaction Questionnaire | Treatment satisfaction will be measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The DTSQ includes eight items on satisfaction with diabetes treatment, convenience, flexibility, understanding of diabetes, possibility of continuation of the current treatment and recommendation to others. Each item is scored on a scale from 0 to 6, with higher score indicating higher satisfaction. | Baseline, 1 Month Post Intervention |
| Change in Medication Adherence | Medication adherence will be determined from prescription fill data and reported in the form of medication possession ratio (the sum of days of supply during a time period divided by the number of days in that time period). The change during six months before and after intervention start (time of assessment of study criteria for the control group) will be reported. | 6 Months Post Intervention |
| Number of Hours Glucose Level in Normal Range | Number of hours patient's glucose level is within normal range of 70-100. | Week 1 and 2 of intervention, Last Two Weeks of Intervention |
| Number of Hours Glucose Level Above Normal Range | Number of hours patient's glucose level is above normal range of 70-100. | Week 1 and 2 of intervention, Last Two Weeks of Intervention |
| Number of Hours Glucose Level Below Normal Range | Number of hours patient's glucose level is below normal range of 70-100. | Week 1 and 2 of intervention, Last Two Weeks of Intervention |
| Average Glucose Level | Average glucose level during the first two weeks of intervention. Normal range is 70-100 mg/dL. A low-level average indicates good glycemic control. A high level indicates uncontrolled diabetes. | Week 1 and 2 of intervention, Last Two Weeks of Intervention |
| Glucose Management Indicator Percentage | The glucose management indicator is an updated approach for estimating hemoglobin A1c from continuous glucose monitoring data. Range is 5.7%-14%. | Week 1 and 2 of intervention, Last Two Weeks of Intervention |
| D004700 | Endocrine System Diseases |