HbA1c accuracy in people with inflammatory arthritis on sulfasalazine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study explores how sulfasalazine may alter HbA1c values independent of actual glucose levels in adults with inflammatory arthritis and diabetes or at risk for diabetes. Researchers will compare HbA1c results with data from continuous glucose monitoring (CGM) to see if HbA1c underestimates true glucose exposure. The study aims to identify how many patients with HbA1c below diabetes thresholds may actually have undiagnosed diabetes, and whether known diabetes is being undertreated due to falsely reassuring HbA1c readings. Participants must be adults with inflammatory arthritis on sulfasalazine and able to use CGM and Danish language data upload. The study is conducted at Medical Diagnostic Center in Silkeborg under a lead sponsor and has no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Treatment with sulfasalazine for at least 2 months prior to inclusion
* Inflammatory arthritis diagnosis (Reumatoid Arthritis, Reaktive Arthritis, Axial spa, Psoriatic spondylitis, and Juvenil artrit)
* HbA1c ≥38 mmol/mol obtained at least 2 months after sulfasalazine initiation OR a diabetes mellitus diagnosis (Type 1 diabetes mellitus, Type 2 diabetes mellitus, Malnutrition-related diabetes mellitus, Other specified diabetes mellitus (andre specificerede former for diabetes), and Unspecified diabetes mellitus (uspecificeret diabetes))
* Can communicate in Danish
* Informed consent including permission to upload glucose data and study ID to the Libreview Platform.

Exclusion Criteria:

* Systemic treatment or local injections with glucocorticoids within the previous 2 months or planned within the following 4 weeks
* Clinical conditions interfering with the interpretation of HbA1c expect for sulfasalazine alterations in red cell lifespan (etc. Dapson treatment)
* Allergy towards the adhesive used in the CGM
* Considered ineligible for participating (e.g. patients without decision-making capacity, , malignancy, terminal illness, ect.)

Where it's running

• Medical Diagnostic Center
  Silkeborg, Central Jutland, Denmark Recruiting

Study contacts

• Principal investigator: Klavs W Hansen, Clinical Professor — Medicial Diagnostic Center, Silkeborg Regional Hospital
• Study coordinator: Katrine B Gørlitz, MD
• Email: kagoer@rm.dk
• Phone: 0045 2421 0787

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.