Diabete Type 2, Steroid-Induced Diabetes, Steroid Induced Hyperglycemia
Conditions
Keywords
Steroid-induced diabetes, Steroid-induced hyperglycaemia, Continuous glucose monitoring
Brief summary
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.
Detailed 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
Interventions
None listed
Sponsors
Medical University of Warsaw
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of diabetes | From enrollment to the end of the observation at 2 weeks | diagnosis of steroid-induced diabetes based on fasting blood glucose 2 times above 126 mg/dl and/or HbA1c\>6.5% and/or blood glucose above 200 mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Target | From enrollment to the end of the observation at 2 weeks | Assessment of Time in range (70-180 mg/dl) |
| Time above 140 mg/dL for ≥10% of the day | From enrollment to the end of the observation at 2 weeks | More than 10% of the day spend in range of glucose levels above 140 mg/dl is associated with significantly increased risk of diabetes |
| Hypoglycaemia Episodes | From enrollment to the end of the observation at 2 weeks | Assessment of Time below range (\<70 mg/dl) through Continuous Glucose Monitoring System |
| Glycemic profile | From enrollment to the end of the observation at 2 weeks | Assessment of glycemic profile through CGM sensor: Glucose monitoring index |
Countries
Poland
Outcome results
None listed