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Recruiting NCT07529366

Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

Conditions: Prediabetes

Sponsor: University of South Florida

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Overview
The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are: 1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group. 2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.
Who can participate
Inclusion Criteria: * adults 18-70 years of age * prediabetes (HbA1c 5.7-6.4%) * compatible smartphone with the Dexcom Stelo sensor system * have not have worn a CGM in the last 6 months prior to enrollment Exclusion Criteria: * any of the following forms of diabetes: type 1 diabetes, type 2 diabetes, monogenic diabetes, cystic fibrosis-related diabetes, post- transplant diabetes, latent autoimmune diabetes * problematic hypoglycemia * pregnant, or planning to become pregnant during the study time frame * currently receiving or planned to receive dialysis during the study time frame - current use of systemic steroids for any condition * a known allergy to medical grade adhesives, * use of any CGM device in the past 6 months * history of a diagnosed eating disorder * current use of a second-generation antipsychotic at the time of consent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone). - - subjects lacking capacity to provide informed consent
Interventions
Dexcom Stelo CGM
DEVICE
Locations 2
United States (2)
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
Tampa , Florida
Kevin Cowart, PharmD, MPH
USF Health Department of Family Medicine - University Partnership Center
Tampa , Florida
Kevin Cowart, PharmD, MPH
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
31.07.2027
Registry ID
NCT07529366
Source
clinicaltrials.gov
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