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NCT Number: NCT04258293

Diabetes Screening in Patients on Long-Term Glucocorticoid Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Person who has orally provided voluntary informed consent.
  • Patient with an indication for prolonged corticosteroid therapy (more than three months)
  • Non-diabetic patient

Exclusion criteria

  • 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

Treatment and study plan

Blood sampling

Diagnostic Test

fasting venous glycemia, venous glycemia after sugar loading, glycated hemoglobin and platelet count

Primary outcomes

  1. fasting venous glycemia

    Time frame: an average of 3 months

  2. venous glycemia after sugar loading

    Time frame: an average of 3 months

  3. Glycated Hemoglobin

    Time frame: an average of 3 months

  4. Platelet Count

    Time frame: an average of 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin BOUILLET

CONTACT

[email protected]

03.80.29.34.53

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: DIACORT

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2020
Registry last updated
Jan 21, 2026

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

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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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