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Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

Recruiting
18-70 years
All
Phase N/A

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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.

Eligibility

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 in the prior 6 months \[defined as recurrent (more than one) level 2 hypoglycemic events (glucose \<54mg/dL ) that persist despite multiple attempts to adjust medication(s) and/or modify the diabetes/treatment plan or a history of one level 3 hypoglycemic event (glucose \<54mg/dL) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia\]
  • 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

Study details
    Prediabetes

NCT07529366

University of South Florida

13 May 2026

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