Type 1 Diabetes (T1D) Clinical Trials

Find Type 1 Diabetes (T1D) Clinical Trials Near You

How Can We Prevent the Underdiagnosis of Diabetes and the Undertreatment of Known Diabetes in Patients With Inflammatory Arthritis Treated With Sulfasalazine?

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Medical Diagnostic Center
RECRUITING
Silkeborg
Contact Information
Primary
Katrine B Gørlitz, MD
kagoer@rm.dk
0045 2421 0787
Time Frame
Start Date: 2026-03-10
Estimated Completion Date: 2026-10
Participants
Target number of participants: 75
Treatments
Inflammatory arthritis with borderline HbA1c
This cohort includes adults with inflammatory arthritis treated with sulfasalazine who do not have a prior diagnosis of diabetes mellitus and have a borderline HbA1c value (≥38 mmol/mol) measured at least two months after initiation of sulfasalazine.~Participants undergo blinded continuous glucose monitoring for up to 14 days to assess actual glucose levels. At the end of the monitoring period, blood samples are obtained for fasting plasma glucose and HbA1c.~Fasting plasma glucose and HbA1c are used to assess the presence of diabetes mellitus, and thereby whether HbA1c and is suitable for the diagnosis of diabetes in patients treated with sulfasalazine. Comparison of HbA1c with CGM-derived glucose measures allows evaluation of whether HbA1c accurately reflects true glycaemic status in patients treated with sulfasalazine.
Inflammatory arthritis with diabetes
This cohort includes adults with inflammatory arthritis and a known diagnosis of diabetes mellitus who are treated with sulfasalazine.~Participants undergo blinded continuous glucose monitoring for up to 14 days to assess average glucose levels. HbA1c is measured during the same period. Comparison of HbA1c with CGM-derived glucose measures allows evaluation of whether HbA1c accurately reflects glycaemic control in patients with established diabetes receiving sulfasalazine.
Sponsors
Leads: Klavs Würgler Hansen

This content was sourced from clinicaltrials.gov