Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes

Medical University of Warsaw

Status: Invitation-only

Conditions: Steroid-Induced Diabetes; Steroid Induced Hyperglycemia; Diabete Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT07190378

KB/90/2025

Details and patient eligibility

About

Glucocorticoids are widely used in the management of autoimmune, inflammatory and neoplastic conditions. However, they are associated with significant metabolic effects, including steroid-induced diabetes (SID). SID is typically diagnosed using general criteria for type 2 diabetes, which may be inadequate due to the unique glycemic profile often seen in SID, where postprandial hyperglycemia predominates. This research aims to explore the diagnostic value of CGM during steroid therapy and identify risk factors for SID This is a prospective observational study (n=250) enrolling adults initiating glucocorticoid therapy. Participants will undergo 14-day continuous glucose monitoring (CGM) to assess predictive factors and glycemic profile.

Full description

Approximately 250 patients hospitalised at Warsaw University Hospital will be enrolled. Baseline data collection includes medical history, anthropometry, HbA1c, and basic biochemical tests. CGM sensors will be applied. The glycemic profile will be monitored for 14 days using the CGM system. If time spent above 140 mg/dL exceeds 10%, capillary glucose testing will be used to confirm diabetes based on established clinical guidelines

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (≥18 years of age)
• No prior diagnosis of diabetes
• Planned initiation of oral and/or intravenous glucocorticoid therapy for non-substitutive indications
• Informed consent

Exclusion criteria

• Age <18 years
• History of diabetes or use of antidiabetic medications
• GC therapy within the past 6 months
• Replacement therapy for primary or secondary adrenal insufficiency, pituitary insufficiency, Nelson's syndrome, or congenital adrenal hyperplasia
• Lack of consent

Trial design

250 participants in 1 patient group

Patients with no prior history of diabetes initiating steroid therapy

Description:

Adult patient without history of diabetes, who are initiating steroid therapy will be enrolled in the study