Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

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:

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.

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