Pharmacist-Led Continuous Glucose Monitoring for Prediabetes
ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dexcom Stelo CGM
DeviceSubjects 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CGM Cohort (Intervention)1 intervention
Group B: No CGM Cohort (Retrospective Cohort)0 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov