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Enrolling By Invitation
NCT05911256
A Community Health Worker/Pharmacist Team to Improve Blood Sugars in Diabetes Care Using Continuous Glucose Monitoring
Conditions: Type 2 Diabetes
Sex: All
Ages: 25 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 318
Sponsor: University of Massachusetts, Worcester
Location: University of Massachusetts Worcester Massachusetts
Summary
Continuous glucose monitoring (CGM) can help improve blood sugar management in type 2 diabetes. A sequential, multiple assignment, randomized trial will evaluate clinical pharmacists, community health workers, and telehealth in supporting CGM use to improve blood sugar control.
Eligibility Criteria
Inclusion Criteria:
* Age 25-75.
* History of T2DM \> 1 year.
* Speak English or Spanish.
* A1c ≥ 8% (within past 6 months) - with reduction if necessary based on recruitment.
* eGFR (estimated glomerular filtration rate) \> 30.
* Willingness to use continuous glucose monitoring (CGM) and work with a community health worker (including home visits) and clinical pharmacist.
Exclusion Criteria:
* Plans for weight reduction surgery or prescription weight loss medication (specific for weight loss, not GLP-1).
* Current, recent, or planned use of CGM.
* Current use of steroids.
* Abuse of illicit drugs.
* Pregnancy (or planned pregnancy).
* Specific comorbidities (e.g., recent MI, TIA, CVA, malignancy, hemoglobinopathy, severe hypoglycemia, etc.).
* Psychiatric disorder that may limit ability to perform study tasks
* Skin changes that preclude use of sensor or allergy to adhesive.
* Planning to leave geographic area within 12 months or distance from clinical site \> 20 miles.
* Participation in another study.
Source: ClinicalTrials.gov (NCT05911256). StuddyBuddy aggregates publicly available trial information.