R73.08
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) HbA1c between 5.7% and 6.4% (inclusive) 2) German Diabetes Risk Score (GDRS) >10%
Exclusion criteria
Exclusion criteria: 1) Diagnosed type 1 or type 2 diabetes mellitus 2) Active malignancy 3) Treatment with oral or intravenous glucocorticoids within the past 3 months 4) Previous treatment with a GLP-1 receptor agonist, tirzepatide, or an SGLT2 inhibitor within the past 12 months 5) Treatment with metformin or pioglitazone within the past 3 months 6) Polycystic ovary syndrome (PCOS) 7) Pregnancy 8) Weight change of more than 5% of body weight within the past 6 months 9) Overt thyroid dysfunction, clinically manifest hypercortisolism, or Addison's disease 10) Bariatric surgery within the past 6 months or planned bariatric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group difference in the change in Time Above Tight Range (TATR; >140 mg/dL) from blinded CGM Phase 1 to blinded CGM Phase 3 (CGM group versus the combined educational brochure and diet and physical activity counseling group). Used continuously glucose measurement systems (CGM): Dexcom G7 or FreeStyle Libre Pro iQ | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group differences in the change in: ? HbA1c from Visit 1 to Visit 6 ? HbA1c from Visit 1 to Visit 4 ? insulin sensitivity (HOMA-IR) from Visit 1 to Visit 6 ? indices of insulin sensitivity and beta-cell function from Visit 1 to Visit 4 ? body weight from Visit 1 to Visit 6 ? body weight from Visit 1 to Visit 4 ? Time In Tight Range (TITR; 70–140 mg/dL) from CGM Phase 1 to CGM Phase 3 ? Time Above Tight Range (TATR; >140 mg/dL) from CGM Phase 1 to CGM Phase 2 Time In Tight Range (TITR; 70–140 mg/dL) from CGM Phase 1 to CGM Phase 3 | — |
Countries
Austria
Contacts
Medizinische Universität Graz, Klinische Abteilung für Endokrinologie und Diabetologie