Pharmacist-led Continuous Glucose Monitoring
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of South Florida
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
type 2 diabetes with hemoglobin A1c ≥ 8%
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor
DeviceSubjects 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Continuous glucose monitoring cohort (intervention)1 intervention
Group B: Self-monitoring of blood glucose cohort (historical 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 (70-180 mg/dL) at 12 weeks, %, compared within the intervention cohort
Time frame
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
Time frame
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
Time frame
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
Time frame
Baseline to End of Study (12 weeks)Sponsors and contacts
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Source ClinicalTrials.gov