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Type 2 DiabetesNCT06572306

Pharmacist-led Continuous Glucose Monitoring

An observational study of Type 2 Diabetes, run by University of South Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor
Type of treatment
Medical device
How many people
11 participants
Where
1 siteUnited States
Study dates
1 Sep 2024to 1 Sep 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: type 2 diabetes with hemoglobin A1c ≥ 8%

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USF Health Department of Family Medicine

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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)
Conditions
Type 2 Diabetes
Being tested
FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor
Keywords
type 2 diabetes, endocrine disorders, continuous glucose monitor, pharmacist
Medical subject headings
Diabetes Mellitus, Type 2, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FreeStyle Libre 2/Libre 3+ Continuous Glucose MonitorDevice

    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.

Study groups in NCT06572306
Study groupRoleWhat they receive
Continuous glucose monitoring cohort (intervention)Freestyle libre 2 or 3+ sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 (libre 2) or 15 (libre 3+) days. Each subject will have 5 visits with a pharmacist over 12 weeks. Subjects meeting inclusion criteria will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8%. Subjects must have a compatible smartphone with the freestyle libre 2 sensor system. Subjects must have access to a glucometer to check blood glucose. Subjects must not have worn a continuous glucose monitor in the last 6 months to be eligible.
Receives: Device: FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor
Self-monitoring of blood glucose cohort (historical cohort)A retrospective chart review will be performed on patients seen by a clinic pharmacist between 1/1/2020-7/1/2024. Subjects in this group will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8% and using a glucometer to monitor blood sugar. Exclusion criteria will be use of any continuous glucose monitoring device within the prior 6 months of the index date (defined as first visit with a pharmacist during study time frame).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemoglobin A1c

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

    Measured: Baseline to End of Study (12 weeks)

Secondary outcomes (12)

  1. Time in Range

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

    Measured: Baseline to End of Study (12 weeks)

  2. Mean Sensor Glucose

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

    Measured: Baseline to End of Study (12 weeks)

  3. Time Below Range

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

    Measured: Baseline to End of Study (12 weeks)

  4. Time Above Range

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

    Measured: Baseline to End of Study (12 weeks)

  5. Glycemic Variability

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

    Measured: Baseline to End of Study (12 weeks)

  6. Time in Range Increase 5%

    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

    Measured: Baseline to End of Study (12 weeks)

  7. Time in Range Increase 10%

    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

    Measured: Baseline to End of Study (12 weeks)

  8. >70% Time in Range

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

    Measured: Baseline to End of Study (12 weeks)

  9. Hemoglobin A1c <7%

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

    Measured: Baseline to End of Study (12 weeks)

  10. Hemoglobin A1c <8%

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

    Measured: Baseline to End of Study (12 weeks)

  11. Summary of Diabetes Self-Care Activities Measure

    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.

    Measured: Baseline to End of Study (12 weeks)

  12. Continuous Glucose Monitoring Survey Responses

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

    Measured: Baseline to End of Study (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start1 Sep 2024
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06572306
Sponsor's protocol ID
STUDY007451
Status last verified
Sep 2026
First submitted
23 Aug 2024
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Cowart K, White RT, Olson K, Carris NW, Hanna K, Zgibor J. Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 May 23;14:e67014. doi: 10.2196/67014.

    PubMed 40409747

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemoglobin A1c (time frame: Baseline to End of Study (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06572306, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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