Validation of Hemoglobin A1c in Patients With Inflammatory Arthritis Treated With Sulfasalazine

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKlavs Würgler Hansen

About this trial

The purpose of this study is to examine whether the blood test Hemoglobin A1c (HbA1c) gives an accurate picture of blood glucose levels in patients with inflammatory arthritis who are treated with sulfasalazine. HbA1c is widely used to diagnose and monitor diabetes, but sulfasalazine can shorten red blood cell lifespan and thereby lower HbA1c values independently of actual glucose levels.

This may lead to underdiagnosis of diabetes in patients who develop diabetes during sulfasalazine treatment, and to undertreatment in patients with known diabetes due to falsely reassuring HbA1c values.

The study aims to answer two main questions:

1. How many patients treated with sulfasalazine have undiagnosed diabetes despite having HbA1c values below the diagnostic threshold? 2. Does HbA1c underestimate actual glucose levels when compared with continuous glucose monitoring (CGM) in patients with sulfasalazine-treated inflammatory arthritis, both in those with known diabetes and those that are not diagnosed with diabetes but have borderline HbA1c values (≥ 38 mmol/mol)?

Eligibility criteria

Qualifiers

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))

Disqualifiers

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.)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

75 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Klavs Würgler Hansen

Lead sponsor

Central Jutland Regional Hospital

Sponsor institution