Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes

NCT07190378 | Enrolling By Invitation

• 1 other identifier: KB/90/2025
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Steroid-induced diabetes; Steroid-induced hyperglycaemia; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Glycemic Target

  From enrollment to the end of the observation at 2 weeks

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

  From enrollment to the end of the observation at 2 weeks

• Hypoglycaemia Episodes

  From enrollment to the end of the observation at 2 weeks

• Glycemic profile

  From enrollment to the end of the observation at 2 weeks

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with no prior history of diabetes initiating steroid therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, Warsaw, 02-097, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Leszek Czupryniak, prof. dr hab. n. med.

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: September 24, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 5, 2028
• Study Completion (Estimated): June 19, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)