Steroid-Induced DiabetesNCT07190378
Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes
An observational study of Steroid-Induced Diabetes and Diabete Type 2, run by Medical University of Warsaw at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Steroid-Induced Diabetes, Diabete Type 2, Steroid Induced Hyperglycemia
- How many people
- 250 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jun 2025to 19 Jun 2028
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with no prior history of diabetes initiating steroid therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Department of Diabetology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland
Warsaw, Warsaw, 02-097
About this study
Official title: Predictive Factors of Steroid-Induced Diabetes and the Role of Continuous Glucose Monitoring in the Diagnosis and Metabolic Control of the Disease
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.
Read the 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
- Keywords
- Steroid-induced diabetes, Steroid-induced hyperglycaemia, Continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of the observation at 2 weeks
Secondary outcomes (4)
Glycemic Target
Assessment of Time in range (70-180 mg/dl)
Measured: 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
Measured: 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
Measured: From enrollment to the end of the observation at 2 weeks
Glycemic profile
Assessment of glycemic profile through CGM sensor: Glucose monitoring index
Measured: From enrollment to the end of the observation at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start20 Jun 2025
- Primary completion5 Jun 2028 (estimated)
- Study completion19 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-Induced DiabetesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Jedrasek, Medical University of Warsaw
- Investigators
- Leszek Czupryniak, prof. dr hab. n. med., Study director, Department of Diabetology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190378
- Sponsor's protocol ID
- KB/90/2025
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Steroid-Induced Diabetes and the Role of Continuous Glucose Monitoring in the Diagnosis and Metabolic Control of the Disease
- ClinicalTrials.gov ID
- NCT07190378
- Acronym / sponsor ID
- KB/90/2025
- Keywords
- Steroid-induced diabetes, Steroid-induced hyperglycaemia, Continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 5 Jun 2028 (estimated)
- Study completion
- 19 Jun 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with no prior history of diabetes initiating steroid therapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Steroid-Induced Diabetes
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CGM After Discharge From Hospital
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CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
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Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes
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The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leszek Czupryniak, prof. dr hab. n. med. study director
Department of Diabetology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steroid-Induced Diabetes and Diabete Type 2, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of diabetes (time frame: From enrollment to the end of the observation at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.