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NCT Number: NCT06572306

Pharmacist-led Continuous Glucose Monitoring

This is a pilot study. The goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. The main questions it aims to answer are:

1. to assess change in hemoglobin A1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no continuous glucose monitoring (only self-monitoring blood glucose with a glucometer). 2. to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group) 3. to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

USF Health Department of Family Medicine

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Kevin Cowart, PharmD, MPH

CONTACT

[email protected]

813-974-5562

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes
  • hemoglobin A1c ≥ 8%
  • compatible smartphone with FreeStyle Libre 2 or Libre 3+ continuous glucose monitoring system
  • current use and access to a glucometer for self-monitoring of blood glucose

Exclusion criteria

  • any continuous glucose monitor use within 6 months prior to study enrollment
  • pregnant and planning to become pregnant during study time frame
  • history of hypoglycemia requiring third party assistance
  • history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to study enrollment
  • known allergy to medical grade adhesives
  • current use of systemic steroids for any medical condition
  • current use of dialysis

Treatment and study plan

FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor

Device

Subjects included in the intervention group (continuous glucose monitoring) will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks.

Primary outcomes

  1. Change in hemoglobin A1c

    Time frame: Baseline to End of Study (12 weeks)

    Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort

Secondary outcomes

  1. Time in Range

    Time frame: Baseline to End of Study (12 weeks)

    Change in the time in range (70-180 mg/dL) at 12 weeks, %, compared within the intervention cohort

  2. Mean Sensor Glucose

    Time frame: Baseline to End of Study (12 weeks)

    Change in mean sensor glucose concentration at 12 weeks, mg/dL, compared within the intervention cohort

  3. Time Below Range

    Time frame: Baseline to End of Study (12 weeks)

    Change in time below range (< 54mg/dL and < 70 mg/dL) at 12 weeks, %, compared within the intervention cohort

  4. Time Above Range

    Time frame: Baseline to End of Study (12 weeks)

    Change in time above range (> 180 mg/dL and > 250 mg/dL) at 12 weeks, %, compared within the intervention cohort

  5. Glycemic Variability

    Time frame: Baseline to End of Study (12 weeks)

    Change in glycemic variability (standard deviation, and Coefficient of variance) at 12 weeks, compared within the intervention cohort

  6. Time in Range Increase 5%

    Time frame: Baseline to End of Study (12 weeks)

    Change in the number of subjects increasing 5% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort

  7. Time in Range Increase 10%

    Time frame: Baseline to End of Study (12 weeks)

    Change in the number of subjects increasing 10% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort

  8. >70% Time in Range

    Time frame: Baseline to End of Study (12 weeks)

    Change in the number of subjects achieving > 70% time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort

  9. Hemoglobin A1c <7%

    Time frame: Baseline to End of Study (12 weeks)

    Change in the number of subjects achieving hemoglobin A1c < 7% at 12 weeks compared between intervention and historical cohort

  10. Hemoglobin A1c <8%

    Time frame: Baseline to End of Study (12 weeks)

    Change in the number of subjects achieving hemoglobin A1c < 8% at 12 weeks compared between intervention and historical cohort

  11. Summary of Diabetes Self-Care Activities Measure

    Time frame: Baseline to End of Study (12 weeks)

    Change in the Summary of Diabetes Self-Care Activities Measure at 12 weeks, compared within the intervention group. Scored on an 8-point likert scale (0-7). Higher scores indicate better compliance with diabetes self-care, whereas a lower score indicate poor self-care performance.

  12. Continuous Glucose Monitoring Survey Responses

    Time frame: Baseline to End of Study (12 weeks)

    Change in survey responses at 12 weeks, compared within the intervention group

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Cowart, PharmD, MPH

CONTACT

[email protected]

813-974-5562

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Investigating the Impact of Pharmacist-led Flash Continuous Glucose Monitoring on Clinical and Behavioral Health Outcomes

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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