Impact of continuous glucose monitoring and patient education on patients with prediabetes identified by point-of- care tests in community pharmacies
Prediabetes defined as having an HbA1c of ≥5.7% and ≤6.4%
Randomization will be conducted with a web-based program available at https://www.meduniwien.ac.at/randomizer using permuted blocks of variable size. A continuous glucose measurement sensor will be applied in the control group after randomization and after 4-6 weeks. Furthermore, patients will receive written information on prediabetes. After 4-9 days of wearing the sensor, a phone consultation with a diabetes specialist will be conducted, in which blood sugar levels and their relationship with food intake will be explained and discussed. In the control group, patients will receive written information at the beginning of the study, a sensor after 3 months and a phone consultation.
1. ≥18 years of age 2. Screening is recommended by the Austrian Diabetes Society: >45 years of age, or >35 years of age with ≥1 risk factor: 2.1. First-degree relatives with diabetes 2.2. BMI ≥25 kg/m² (or ≥23 kg/m² for people with Asian descent) 2.3. Metabolic syndrome 2.4. Arterial hypertension 2.5. Dyslipidemia 2.6. Steatosis hepatis 2.7. History of gestational diabetes 2.8. Polycystic ovary syndrome For Interventional Trial: 1. HbA1c% of ≥5.7% and ≤6.4% 2. Willingness to participate in the study and comply with the study’s requirements: 2.1. To wear a continuous glucose monitoring sensor for the projected time (maximum 14 days) 2.2. To share quantified glucose concentrations with the study team 2.3. To participate in all planned visits within the planned time-frame 2.4. To document their food intake during CGM periods (e.g., via taking photos or notes) 2.5. To have a smartphone
For Screening Part: 1. Prior diagnosis with prediabetes or diabetes 2. Treatment with antidiabetic drugs For Interventional Trial: 1. Inability to comply with the trial’s requirements 2. Skin conditions or prohibiting the use of a glucose monitor (wounds, eczema, dermatitis, infections, sunburns, etc) 3. Allergies or intolerances against the sensor or its materials/constituents, e.g., allergies against acrylic adhesive, isobornyl acrylate (IBOA), polyurethane, epoxy resins, plaster and tapes 4. Pregnancy or breastfeeding 5. Planned magnetic resonance imaging or computed tomography scans during the times when the CGM should be worn 6. Planned treatment with diathermy 7. Pregnancy – females with an ongoing pregnancy with prediabetes must not participate in the trial 8. Intake of methyldopa or high doses of Vitamin C (>500 mg/day or intravenous Vitamin C) 9. Intake of systemic corticosteroids