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Enrolling by Invitation

NCT Number: NCT07190378

Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes

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.

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Key information

Conditions

Steroid-Induced Diabetes Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Steroid Induced Hyperglycemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Diabetology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland

Warsaw, 02-097, Poland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnosis of diabetes

    Time frame: 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 outcomes

  1. Glycemic Target

    Time frame: From enrollment to the end of the observation at 2 weeks

    Assessment of Time in range (70-180 mg/dl)

  2. Time above 140 mg/dL for ≥10% of the day

    Time frame: 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

  3. Hypoglycaemia Episodes

    Time frame: From enrollment to the end of the observation at 2 weeks

    Assessment of Time below range (<70 mg/dl) through Continuous Glucose Monitoring System

  4. Glycemic profile

    Time frame: From enrollment to the end of the observation at 2 weeks

    Assessment of glycemic profile through CGM sensor: Glucose monitoring index

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Predictive Factors of Steroid-Induced Diabetes and the Role of Continuous Glucose Monitoring in the Diagnosis and Metabolic Control of the Disease

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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