Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Great Plains IDeA-CTR | UNKNOWN |
Not provided
Not provided
Not provided
Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. The purpose of this study is to further understand the benefits and barriers associated with CGM use in underserved populations with type 2 diabetes and improve their overall diabetes care.
Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. This study will evaluate the perceived and experienced benefits and barriers of continuous glucose monitor (CGM) and traditional glucometer use and identify diabetes related outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose (SMBG) in an underserved population.
Eligible adult (>=19 years of age) patients at participating clinics with type 2 diabetes, A1c >=9%, and concomitant insulin therapy and/or using two or more diabetes medications will be randomly enrolled to one of two groups: Freestyle Libre 2 CGM or traditional glucometer. Pre- and post-surveys will be used to evaluate perceived and experienced benefits and barriers to CGM use and diabetes-related outcomes will be compared between the groups using face-to-face, telephonic, and/or digital avenues. The latter aim will replicate current processes of team-based diabetes care which is blood glucose management from a pharmacist under collaborative practice with the primary care physician. Follow-up will also replicate these clinic processes throughout the 6-month period, including telephone calls and monthly in-clinic visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring | Experimental | Participants will use a Freestyle Libre 2 monitoring device for 6 months to track blood glucose levels. |
|
| Traditional Glucometer Arm | Active Comparator | Participants will use a traditional glucose monitoring device (glucometer) to self-monitor their blood glucose for 6 months to track blood glucose levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Device | A Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control (Hemoglobin A1c) | Glycemic control will be assessed by measuring hemoglobin A1c at baseline, 3 months, and 6 months. Values will be evaluated as a continuous variable and categorized as <7.0% vs >7.0% to <9.0% and >9.0%. Comparisons of the proportions of participants achieving a minimum of 1 point drop in hemoglobin A1c will be made between study arms. | Baseline, 3 months, and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia | Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine number and percentage of hypoglycemic readings (i.e., <70 mg/dL). For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Drew C Prescott, PharmD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nebraska Medicine | Omaha | Nebraska | 68198-7400D | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Participants will be assigned to one of two groups and receive either the treatment intervention, continuous glucose monitor (CGM), or standard of care intervention ,traditional glucometer, upon enrollment.
Not provided
Not provided
Not provided
Not provided
|
| Self-monitoring Blood Glucose (SMBG) | Device | A traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months. |
|
|
| Hyperglycemia |
Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine percentage of hyperglycemic values (i.e., >180 mg/dl) experienced. For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described. |
| 6 months |
| Blood Glucose Capture Rate | Number of days without any blood glucose recordings will be captured as a percentage over the study period. | 6 months |
| Perceived or Experienced Benefits and Barriers to Device Use | A pre- and post-survey will be provided to all participants to qualitatively identify benefits and barriers to access and use of their assigned device and willingness to continue CGM use (follow-up survey). | Baseline and 6 months |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |