Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALContinuous Glucose Monitor
Patient will be provided a continuous glucose monitor. Pharmacist will provide information regarding how to best manage type 2 diabetes.
BEHAVIORALUsual Care
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.
Sponsors
American Society of Health-System Pharmacists
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hispanic or non-Hispanic Black * Diagnosis of Type 2 diabetes * HbA1c ≥8% within the past 3 months * Active prescription for insulin and injecting at least 1 time daily
Exclusion criteria
* Gestational diabetes * Type 1 diabetes * Receiving care by endocrinologist * Continuous glucose monitor use within the past 6 months * Receiving long term, hospice, or palliative care services * Malignant cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | Baseline to Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Treatment Satisfaction Questionnaire | Baseline, 1 Month Post Intervention | 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. |
| Change in Medication Adherence | 6 Months Post Intervention | 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. |
| Number of Hours Glucose Level in Normal Range | Week 1 and 2 of intervention, Last Two Weeks of Intervention | Number of hours patient's glucose level is within normal range of 70-100. |
| Appraisal of Diabetes Scale | Baseline, 1 Month Post Intervention | 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. |
| Number of Hours Glucose Level Below Normal Range | Week 1 and 2 of intervention, Last Two Weeks of Intervention | Number of hours patient's glucose level is below normal range of 70-100. |
| Average Glucose Level | Week 1 and 2 of intervention, Last Two Weeks of Intervention | 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. |
| Glucose Management Indicator Percentage | Week 1 and 2 of intervention, Last Two Weeks of Intervention | The glucose management indicator is an updated approach for estimating hemoglobin A1c from continuous glucose monitoring data. Range is 5.7%-14%. |
| Number of Hours Glucose Level Above Normal Range | Week 1 and 2 of intervention, Last Two Weeks of Intervention | Number of hours patient's glucose level is above normal range of 70-100. |
Countries
United States
Outcome results
None listed