Impact of a device that continuously measures glucose levels and patient education using written information and a consultation with a physician specialising on diabetes on patients with prediabetes identified by point-of-care tests in community pharmacies

1. Approved 08/04/2026, Ethics committee of the city of Vienna (Thomas-Klestil-Platz 8/2, TownTown - Eingang: 3, Vienna, 1030, Austria; +43 (0)1 4000-87754; ethikkommission@ma15.wien.gv.at), ref: EK_25_251_0326

2. Approved 27/02/2026, Ethics Committee of the Medical University of Vienna (Borschkegasse 8b/E06, Vienna, 1090, Austria; +43 (0)1 4040021470; ethik-kom@meduniwien.ac.at), ref: 2346/2025

1. HbA1c% measured using capillary blood samples and point-of-care devices at baseline to 3 months

1. Number of patients at screening with HbA1c ≥5.7% measured using capillary blood samples and point-of-care devices at baseline
2. Number of patients at screening with HbA1c ≥6.5% measured using capillary blood samples and point-of-care devices at baseline
3. Number of patients at screening with HbA1c ≥5.7% and ≤6.4% measured using capillary blood samples and point-of-care devices at baseline
4. Successful referral rate to treating physicians for patients with HbA1c of ≥6.5% using short-message-service-based reminders measured using telephone call or email confirmation at 3 months after study HbA1c quantification
5. Successful referral rate to treating physicians for patients with HbA1c of 5.7-6.4% using short-message-service-based reminders measured using telephone call or email confirmation at 3 months after study HbA1c quantification
6. Successful referral rate to treating physicians for patients with HbA1c of ≥5.7% using short-message-service-based reminders measured using telephone call or email confirmation at 3 months after study HbA1c quantification
7. HbA1c% concentrations after 6 months compared to baseline between interventional group and control group measured using HbA1c% measured using capillary blood samples and point-of-care devices at baseline to 6 months
8. In the control group: HbA1c% concentrations after 6 months (3 months after continuous glucose measurement Phase) vs baseline and vs 3 months measured using capillary blood samples and point-of-care devices at 3 months to 6 months
9. Various glucose indices compared between continuous glucose measurement Phase 1 and continuous glucose measurement Phase 2 in the interventional group (Time in Range, Time in Tight Range, continuous overall net glycemic action (CONGA)- 1h, CONGA-2h, CONGA-4h, mean glucose, median glucose, standard deviation of glucose, coefficient of variation of glucose, mean amplitude of glycemic excursions (MAGE), Mean of Daily Differences (MODD), time below range, time above range) measured using blood sugar concentrations quantified by continuous glucose measurement device at CGM phase 1 (first 10-14 days) and CGM Phase 2 (second 10-14 days), which takes place 4-6 weeks after randomization
10. Various glucose indices within the continuous glucose measurement Phase 1 (in the intervention and control group) comparing the first 50% and the second 50% of the continuous glucose measurement duration (maximum 14 days, minimum to be eligible 7d, e.g. if the sensor is worn for 10 days – 5 vs 5 days) measured using blood sugar concentrations quantified by continuous glucose measurement device at CGM Phase 1 first half vs second half
11. Patient experiences with continuous glucose monitoring and the consultation measured using questionnaire, Likert Scale at 3 months (interventional group); 6 months (control group)