Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Steroid-Induced Diabetes, Diabete Type 2, Steroid Induced Hyperglycemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predictive Factors of Steroid-Induced Diabetes and the Role of Continuous Glucose Monitoring in the Diagnosis and Metabolic Control of the Disease
Overview
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
Primary outcome measures
- Diagnosis of diabetes [Time frame: From enrollment to the end of the observation at 2 weeks]
Secondary outcome measures (4)
- Glycemic Target [Time frame: From enrollment to the end of the observation at 2 weeks]
- Time above 140 mg/dL for ≥10% of the day [Time frame: From enrollment to the end of the observation at 2 weeks]
- Hypoglycaemia Episodes [Time frame: From enrollment to the end of the observation at 2 weeks]
- Glycemic profile [Time frame: From enrollment to the end of the observation at 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Department of Diabetology and Internal Medicine, Medical University of Warsaw, Warsaw, Pol — Warsaw
Identifiers
NCT: NCT07190378 · KB/90/2025