An observational study in Prediabetes, sponsored by University of South Florida. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of South Florida · Observational
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:
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 40 is below the median of 224 across 129 observational studies indexed under Prediabetic State.
Browse Prediabetic State studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Dexcom Stelo CGM
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.
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.
Change in hemoglobin A1c
Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort
Time frame: Baseline to End of Study (12 weeks)
Time in Range
Change in the time in range (70-140 mg/dL) at 4 weeks, %, compared within the intervention cohort
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to End of Week 4 (CGM wear period)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jul 2027, 9 months after the start.
Of 48 observational studies under Prediabetic State, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 24. This study's planned 9 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 7, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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