GlucocorticosteroidDIACORTNCT04258293
Diabetes Screening in Patients on Long-Term Glucocorticoid Therapy
An observational study of Glucocorticosteroid and Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Glucocorticoids are widely prescribed in the treatment of many inflammatory, autoimmune or allergic diseases, but also in transplant patients or patients with malignant hematological diseases (leukaemia, lymphoma, myeloma, etc.). They have many side effects, including effects on carbohydrate metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucocorticosteroid, Diabetes
- What is being tested?
- Blood sampling
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2020to May 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: inpatients and outpatients
Who may be able to join
- Person who has orally provided voluntary informed consent.
- Patient with an indication for prolonged corticosteroid therapy (more than three months)
- Non-diabetic patient
Who cannot join
- Person not affiliated to or not benefiting from national health insurance system
- Person subject to legal protection (guardianship, curatorship)
- Pregnant or breastfeeding woman
- Adult unable to provide consent
- Minor
- Evidence of fasting venous blood glucose greater than 1.26 g/L, or Glycated haemoglobin greater than 6.5% at the time of initial blood sampling before glucocorticoid treatment.
- Patient who had received corticosteroid therapy within 3 months prior to the study
- Patient with hemoglobin less than 10 g/dL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Benjamin BOUILLET, 03.80.29.34.53 ext. 33, benjamin.bouillet@chu-dijon.fr
About this study
Glucocorticoids are widely prescribed in the treatment of many inflammatory, autoimmune or allergic diseases, but also in transplant patients or patients with malignant hematological diseases (leukaemia, lymphoma, myeloma, etc.). They have many side effects, including effects on carbohydrate metabolism.
Corticosteroids are diabetogenic because they disrupt pancreatic insulin secretion and decrease the insulin sensitivity of target tissues (liver, muscle, adipose tissue).
Read more
The use of glucocorticoids may lead to the development of corticosteroid-induced diabetes in non-diabetic patients.
Corticosteroid-induced diabetes is frequently found in clinical practice. Incidence figures for corticosteroid-induced diabetes vary widely.
Case-control studies show odds ratios of corticosteroid-induced diabetes onset ranging from 1.36 and 2.23. In two of these studies, the diagnostic criterion was the prescription of a hypoglycemic treatment. Smaller studies, retrospective or prospective, show incidence rates of corticosteroid-induced diabetes ranging from 8.8 to 52%. This difference in incidence rates is explained by the different glucocorticoid doses, glucocorticoid durations, conditions requiring glucocorticoid therapy, and diagnostic criteria for corticosteroid-induced diabetes that vary from study to study. In kidney transplantation, diabetes concerns 16% of patients before the age of 40, and up to 52% after the age of 50. The diagnostic criteria used in the literature are often fasting and post prandial glycemia. The differences in incidence rates found with these two diagnostic methods can be explained by the pharmacokinetics of glucocorticoids. The main glucocorticoids prescribed have a duration of action of 12 to 16 hours. As they are generally prescribed in the morning as a single daily dose, fasting morning blood glucose levels are often normal while postprandial blood glucose levels are increased. This observation has been presented in 2 studies. However, the 2 diagnostic criteria were not statistically compared in these studies.
While according to the American Diabetes Association, the 3 criteria used to diagnose diabetes are fasting glycemia, glycemia 2 hours after an oral glucose load of 75 g and glycated hemoglobin, these last 2 diagnostic criteria are, to the investigator's knowledge, not used in the scientific literature to screen for corticosteroid-induced diabetes.
In current practice, the diagnostic criteria used are disparate. To date, there are no studies that have determined which diagnostic criterion is the most effective in screening for corticosteroid-induced diabetes. The current recommendations recommend early diagnosis and treatment in order to achieve satisfactory glycemic control as quickly as possible. These recommendations have been shown to be effective in reducing the risk of degenerative complications of diabetes, but it is important to screen for corticosteroid-induced diabetes with the most relevant diagnostic criterion in order to optimise its management.
- Conditions
- Glucocorticosteroid, Diabetes
- Being tested
- Blood sampling
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
fasting venous glycemia, venous glycemia after sugar loading, glycated hemoglobin and platelet count
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients on prolonged corticosteroid therapy (more than three months) Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting venous glycemia
Measured: an average of 3 months
venous glycemia after sugar loading
Measured: an average of 3 months
Glycated Hemoglobin
Measured: an average of 3 months
Platelet Count
Measured: an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start6 Feb 2020
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlucocorticosteroidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258293
- Sponsor's protocol ID
- BOUILLET 2018-2
- Acronym
- DIACORT
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Screening in Patients on Long-Term Glucocorticoid Therapy
- ClinicalTrials.gov ID
- NCT04258293
- Acronym / sponsor ID
- DIACORT / BOUILLET 2018-2
- Conditions
- Glucocorticosteroid, Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 6 Feb 2020 (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 prescribed in the treatment of many inflammatory, autoimmune or allergic diseases, but also in transplant patients or patients with malignant hematological diseases (leukaemia, lymphoma, myeloma, etc.). They have many side effects, including effects on carbohydrate metabolism.
Corticosteroids are diabetogenic because they disrupt pancreatic insulin secretion and decrease the insulin sensitivity of target tissues (liver, muscle, adipose tissue).
The use of glucocorticoids may lead to the development of corticosteroid-induced diabetes in non-diabetic patients.
Corticosteroid-induced diabetes is frequently found in clinical practice. Incidence figures for corticosteroid-induced diabetes vary widely.
Case-control studies show odds ratios of corticosteroid-induced diabetes onset ranging from 1.36 and 2.23. In two of these studies, the diagnostic criterion was the prescription of a hypoglycemic treatment. Smaller studies, retrospective or prospective, show incidence rates of corticosteroid-induced diabetes ranging from 8.8 to 52%. This difference in incidence rates is explained by the different glucocorticoid doses, glucocorticoid durations, conditions requiring glucocorticoid therapy, and diagnostic criteria for corticosteroid-induced diabetes that vary from study to study. In kidney transplantation, diabetes concerns 16% of patients before the age of 40, and up to 52% after the age of 50. The diagnostic criteria used in the literature are often fasting and post prandial glycemia. The differences in incidence rates found with these two diagnostic methods can be explained by the pharmacokinetics of glucocorticoids. The main glucocorticoids prescribed have a duration of action of 12 to 16 hours. As they are generally prescribed in the morning as a single daily dose, fasting morning blood glucose levels are often normal while postprandial blood glucose levels are increased. This observation has been presented in 2 studies. However, the 2 diagnostic criteria were not statistically compared in these studies.
While according to the American Diabetes Association, the 3 criteria used to diagnose diabetes are fasting glycemia, glycemia 2 hours after an oral glucose load of 75 g and glycated hemoglobin, these last 2 diagnostic criteria are, to the investigator's knowledge, not used in the scientific literature to screen for corticosteroid-induced diabetes.
In current practice, the diagnostic criteria used are disparate. To date, there are no studies that have determined which diagnostic criterion is the most effective in screening for corticosteroid-induced diabetes. The current recommendations recommend early diagnosis and treatment in order to achieve satisfactory glycemic control as quickly as possible. These recommendations have been shown to be effective in reducing the risk of degenerative complications of diabetes, but it is important to screen for corticosteroid-induced diabetes with the most relevant diagnostic criterion in order to optimise its management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Blood samplingPatients on prolonged corticosteroid therapy (more than three months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- inpatients and outpatients
Key inclusion criteria (3 listed)
- Person who has orally provided voluntary informed consent.
- Patient with an indication for prolonged corticosteroid therapy (more than three months)
- Non-diabetic patient
Key exclusion criteria (8 listed)
- Person not affiliated to or not benefiting from national health insurance system
- Person subject to legal protection (guardianship, curatorship)
- Pregnant or breastfeeding woman
- Adult unable to provide consent
- Minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingfasting venous glycemia, venous glycemia after sugar loading, glycated hemoglobin and platelet count | Diagnostic test | Patients |
Primary outcome
fasting venous glycemia
Time frame: an average of 3 months
venous glycemia after sugar loading
Time frame: an average of 3 months
Glycated Hemoglobin
Time frame: an average of 3 months
Platelet Count
Time frame: an average of 3 months
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 21 Jan 2026.
Related trials for Glucocorticosteroid
Not yet recruitingPhase 4
Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis
Uveitis
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.
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 Glucocorticosteroid and Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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 France. 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?
Contact Benjamin BOUILLET (03.80.29.34.53, benjamin.bouillet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting venous glycemia (time frame: an average of 3 months). The study lists 4 primary outcomes in all. 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 21 Jan 2026.