Pharmacist-Led Continuous Glucose Monitoring for Prediabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexcom Stelo CGM.
- Who it may be relevant to
- Registry conditions: Prediabetes. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change
Overview
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. 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. 2. 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.
Interventions
- Device Dexcom Stelo 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.
Primary outcome measures
- Change in hemoglobin A1c [Time frame: Baseline to End of Study (12 weeks)]
Secondary outcome measures (12)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- USF Health Department of Family Medicine - Morsani Center for Advanced Health Care — Tampa
- USF Health Department of Family Medicine - University Partnership Center — Tampa
Identifiers
NCT: NCT07529366 · STUDY009771