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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with no prior history of diabetes initiating steroid therapy | Adult patient without history of diabetes, who are initiating steroid therapy will be enrolled in the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of diabetes | 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 | From enrollment to the end of the observation at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Target | Assessment of Time in range (70-180 mg/dl) | From enrollment to the end of the observation at 2 weeks |
| Time above 140 mg/dL for ≥10% of the day | More than 10% of the day spend in range of glucose levels above 140 mg/dl is associated with significantly increased risk of diabetes |
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Inclusion criteria:
Exclusion criteria:
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Adult patients with no prior history of diabetes initiating steroid therapy
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| Name | Affiliation | Role |
|---|---|---|
| Leszek Czupryniak, prof. dr hab. n. med. | Department of Diabetology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Diabetology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland | Warsaw | Warsaw | 02-097 | Poland |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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blood samples
| From enrollment to the end of the observation at 2 weeks |
| Hypoglycaemia Episodes | Assessment of Time below range (<70 mg/dl) through Continuous Glucose Monitoring System | From enrollment to the end of the observation at 2 weeks |
| Glycemic profile | Assessment of glycemic profile through CGM sensor: Glucose monitoring index | From enrollment to the end of the observation at 2 weeks |
| D004700 | Endocrine System Diseases |