Pharmacist-led continuous glucose monitoring for people with prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational program uses pharmacist-led wearable continuous glucose monitoring (Dexcom Stelo) in adults with prediabetes and compares outcomes to a historical cohort without CGM. The primary metabolic endpoint is change in hemoglobin A1c at 12 weeks, and investigators will also compare CGM-derived glycemic metrics from baseline to the end of the wear period in the intervention group. Health behavior and quality-of-life changes will be measured with the Summary of Diabetes Self-Care Activities (SDSCA) and the SF-36 at baseline, week 4, and study end. Participants must be 18–70 years old, have prediabetes-range A1c, and a smartphone compatible with the Dexcom Stelo system.

Why it matters

Who can join: the full rules

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

Where it's running

• USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
  Tampa, Florida, United States Recruiting
• USF Health Department of Family Medicine - University Partnership Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Kevin Cowart, PharmD, MPH — University of South Florida
• Study coordinator: Kevin Cowart, PharmD, MPH
• Email: kcowart2@usf.edu
• Phone: 813-974-5562

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.