PrediabetesNCT07529366
Pharmacist-Led Continuous Glucose Monitoring for Prediabetes
An observational study of Prediabetes, run by University of South Florida at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Dexcom Stelo CGM
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Oct 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
Tampa, Florida, 33612
Kevin Cowart, PharmD, MPH, 813-974-5562, kcowart2@usf.edu
- Recruiting
USF Health Department of Family Medicine - University Partnership Center
Tampa, Florida, 33613
Kevin Cowart, PharmD, MPH, 813-974-5562, kcowart2@usf.edu
About this study
Official title: Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change
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:
- 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.
- 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.
- Conditions
- Prediabetes
- Being tested
- Dexcom Stelo CGM
- Keywords
- prediabetes, continuous glucose monitoring, pharmacist, health behavior, Hemoglobin A1c, endocrinology, primary care, CGM
- Medical subject headings
- Prediabetic State, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Stelo CGMDevice
Subjects included in the intervention group will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks. The CGM sensors are worn on the upper arm and changed every 15 days.
| Study group | Role | What they receive |
|---|---|---|
| CGM Cohort (Intervention) | Subjects meeting inclusion criteria will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%) obtained within the six months preceding enrollment. Subjects must have a compatible smartphone with the Dexcom CGM sensor system. Subjects must not have worn a CGM in the last 6 months to be eligible. Receives: Device: Dexcom Stelo CGM | |
| No CGM Cohort (Retrospective Cohort) | A retrospective chart review will be performed on patients seen at the USF Health Department of Family Medicine between 1/1/2025-03/20/2026. Subjects in this group will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%). Subjects in this cohort will have not received CGM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (16)
Time in Range
Change in the time in range (70-140 mg/dL) at 4 weeks, %, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range
Change in the time in euglycemic range (54-120 mg/dL) at 4 weeks, %, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Mean Sensor Glucose
Change in mean sensor glucose concentration at 4 weeks, mg/dL, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Time Below Range
Change in time below range (< 70 mg/dL) at 4 weeks, %, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Time Above Range
Change in time above range (141-250 mg/dL and > 250 mg/dL) at 4 weeks, %, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Glycemic Variability
Change in glycemic variability (standard deviation, and Coefficient of variance) at 4 weeks, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Time in Range Increase 5%
Change in the number of subjects increasing 5% or more in time in range (70-140 mg/dL) at 4 weeks, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Time in Range Increase 10%
Change in the number of subjects increasing 10% or more in time in range (70-140 mg/dL) at 4 weeks, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range Increase 5%
Change in the number of subjects increasing 5% or more in time in euglycemic range (54-120 mg/dL) at 4 weeks, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range Increase 10%
Change in the number of subjects increasing 10% or more in time in euglycemic range (54-120 mg/dL) at 4 weeks, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
>70% Time in Range
Change in the number of subjects achieving > 70% time in range (70-140 mg/dL) at 4 weeks, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
>70% Time in Euglycemic Range
Change in the number of subjects achieving > 70% time in euglycemic range (54-120 mg/dL) at 4 weeks, compared within the intervention cohort
Measured: Baseline to End of Week 4 (CGM wear period)
Summary of Diabetes Self-Care Activities Measure (SDSCA)
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)
Summary of Diabetes Self-Care Activities Measure (SDSCA)
Change in the Summary of Diabetes Self-Care Activities Measure at 4 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 Week 4 (CGM wear period)
36-Item Short Form Health Survey (SF-36)
Change in the 36-Item Short Form Health Survey (SF-36) Measure at 12 weeks, compared within the intervention group. Produces 8 domain scores and is scored on a 0 to 100 scale. For the standard domain scores, higher scores indicate a more favorable health state. A score of 100 reflects the best health status on that domain, and 0 the worst.
Measured: Baseline to End of Study (12 weeks)
36-Item Short Form Health Survey (SF-36)
Change in the 36-Item Short Form Health Survey (SF-36) Measure at 12 weeks, compared within the intervention group. Produces 8 domain scores and is scored on a 0 to 100 scale. For the standard domain scores, higher scores indicate a more favorable health state. A score of 100 reflects the best health status on that domain, and 0 the worst.
Measured: Baseline to End of Week 4 (CGM wear period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start6 Oct 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Cowart, University of South Florida
- Investigators
- Kevin Cowart, PharmD, MPH, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529366
- Sponsor's protocol ID
- STUDY009771
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 7 Oct 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, Carris NW, Ansong BO, Hinden A, Clayton G, Petrilli J, Coris E. Pharmacist-Led Continuous Glucose Monitoring for Prediabetes: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2026 Oct 15;15:e105275. doi: 10.2196/105275.
PubMed 42879771
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change
- ClinicalTrials.gov ID
- NCT07529366
- Acronym / sponsor ID
- STUDY009771
- Conditions
- Prediabetes
- Keywords
- prediabetes, continuous glucose monitoring, pharmacist, health behavior, Hemoglobin A1c, endocrinology, primary care, CGM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM Cohort (Intervention) | – | Device: Dexcom Stelo CGMSubjects meeting inclusion criteria will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%) obtained within the six months preceding enrollment. Subjects must have a compatible smartphone with the Dexcom CGM sensor system. Subjects must not have worn a CGM in the last 6 months to be eligible. |
| No CGM Cohort (Retrospective Cohort) | – | –A retrospective chart review will be performed on patients seen at the USF Health Department of Family Medicine between 1/1/2025-03/20/2026. Subjects in this group will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%). Subjects in this cohort will have not received CGM. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom Stelo CGMSubjects included in the intervention group will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks. The CGM sensors are worn on the upper arm and changed every 15 days. | Device | CGM Cohort (Intervention) |
Primary outcome
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
16 secondary outcomes
Time in Range
Time frame: Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range
Time frame: Baseline to End of Week 4 (CGM wear period)
Mean Sensor Glucose
Time frame: Baseline to End of Week 4 (CGM wear period)
Time Below Range
Time frame: Baseline to End of Week 4 (CGM wear period)
Time Above Range
Time frame: Baseline to End of Week 4 (CGM wear period)
Glycemic Variability
Time frame: Baseline to End of Week 4 (CGM wear period)
Time in Range Increase 5%
Time frame: Baseline to End of Week 4 (CGM wear period)
Time in Range Increase 10%
Time frame: Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range Increase 5%
Time frame: Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range Increase 10%
Time frame: Baseline to End of Week 4 (CGM wear period)
>70% Time in Range
Time frame: Baseline to End of Week 4 (CGM wear period)
>70% Time in Euglycemic Range
Time frame: Baseline to End of Week 4 (CGM wear period)
Summary of Diabetes Self-Care Activities Measure (SDSCA)
Time frame: Baseline to End of Study (12 weeks)
Summary of Diabetes Self-Care Activities Measure (SDSCA)
Time frame: Baseline to End of Week 4 (CGM wear period)
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline to End of Study (12 weeks)
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline to End of Week 4 (CGM wear period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 42879771Cowart K, White RT, Carris NW, Ansong BO, Hinden A, Clayton G, Petrilli J, Coris E. Pharmacist-Led Continuous Glucose Monitoring for Prediabetes: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2026 Oct 15;15:e105275. doi: 10.2196/105275.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Cowart, PharmD, MPH principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes, run by University of South Florida at 2 sites 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 9 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Cowart, PharmD, MPH (813-974-5562, kcowart2@usf.edu), or a site near the patient. 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 NCT07529366, 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 7 Oct 2026.