A Community Health Worker/Pharmacist Team to Improve Blood Sugars in Diabetes Care Using Continuous Glucose Monitoring
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT05911256
- Lead Sponsor
- University of Massachusetts, Worcester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age 25-75.<br><br> - History of T2DM > 1 year.<br><br> - Speak English or Spanish.<br><br> - A1c = 9% (within past 6 months) - with reduction if necessary based on recruitment.<br><br> - eGFR (estimated glomerular filtration rate) > 30.<br><br> - Willingness to use continuous glucose monitoring (CGM) and work with a community<br> health worker (including home visits) and clinical pharmacist.<br><br>Exclusion Criteria:<br><br> - Plans for weight reduction surgery or prescription weight loss medication (specific<br> for weight loss, not GLP-1).<br><br> - Current, recent, or planned use of CGM.<br><br> - Current use of steroids.<br><br> - Abuse of illicit drugs.<br><br> - Pregnancy (or planned pregnancy).<br><br> - Specific comorbidities (e.g., recent MI, TIA, CVA, malignancy, hemoglobinopathy,<br> severe hypoglycemia, etc.).<br><br> - Psychiatric disorder that may limit ability to perform study tasks<br><br> - Skin changes that preclude use of sensor or allergy to adhesive.<br><br> - Planning to leave geographic area within 12 months or distance from clinical site ><br> 20 miles.<br><br> - Participation in another study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in participant HbA1c values
- Secondary Outcome Measures
Name Time Method Change in glycemic control from baseline using Percent Time in Range;Change in Participant self-reported health-related quality of life from baseline;Change in participant reported Diabetes Self-Management from baseline;Changes in participant reported Diabetes Distress from baseline;Change in participant-reported diabetes treatment burden from baseline;Frequency of participant Healthcare Utilization;Change in mean glycemic control from baseline;Hyperglycemia event rate;Change in Glycemic variability from baseline