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Inflammatory ArthritisDIA2SULFANCT07416656

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

An observational study of Inflammatory Arthritis and Diabetes (DM), run by Klavs Würgler Hansen at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
75 participants
Where
1 siteDenmark
Study dates
10 Mar 2026to Oct 2026
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: Patients will be recruited from the rheumatology outpatient clinic at the Medicial Diagnostic Center, Silkeborg Regional Hospital. Potential participants will be identified electronically using registry data. Scrutiny of their electronical medical records will be performed to confirm eligibility based on the above mentioned inclusion and exclusion criteria.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katrine B Gørlitz, MD contact

0045 2421 0787

kagoer@rm.dk

Denmark1 site, 1 recruiting
  • Medical Diagnostic Center

    Silkeborg, Central Jutland, 8600

    Katrine B Gørlitz, MD, +45 24210787, kagoer@rm.dk

    Recruiting

Other trials in Denmark

About this study

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

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.

Read more

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)?
Read the detailed description

HbA1c is widely used to diagnose diabetes and to monitor long-term glycaemic control. HbA1c reflects average blood glucose levels over approximately two months but can be influenced by factors unrelated to glucose, including changes in red blood cell lifespan. Sulfasalazine, a disease-modifying antirheumatic drug commonly used to treat inflammatory arthritis, is known to cause mild haemolysis in some patients, which can lower HbA1c values independently of actual glucose levels.

This effect may have important clinical consequences. In patients without diabetes at the start of sulfasalazine treatment, HbA1c values may remain below diagnostic thresholds even if diabetes develops over time, potentially delaying diagnosis. In patients with established diabetes, sulfasalazine-associated lowering of HbA1c may give a misleading impression of adequate glycaemic control, which may result in insufficient treatment intensification despite elevated true glucose levels. Together, these mechanisms may contribute to underdiagnosis and undertreatment of diabetes in patients receiving sulfasalazine.

CGM provides direct, sensor-based measurements of interstitial glucose levels and is not affected by red blood cell turnover. CGM therefore offers an opportunity to assess actual glycaemic exposure independently of HbA1c. However, prospective data comparing HbA1c with CGM-derived glucose measures in sulfasalazine-treated patients with inflammatory arthritis are lacking.

This study is a prospective observational investigation conducted in patients with inflammatory arthritis treated with sulfasalazine. Participants include both individuals with known diabetes and individuals without known diabetes who have HbA1c values in the borderline range. Each participant undergoes a single study phase in which blinded CGM is worn for up to 14 days, with blood sampling performed within the same time period. In participants without known diabetes, fasting plasma glucose measurements are used to evaluate the presence of previously unrecognised diabetes.

By comparing HbA1c values with CGM-derived average glucose levels, the study aims to evaluate whether HbA1c accurately reflects glycaemic status in sulfasalazine-treated patients. The results are expected to improve understanding of the limitations of HbA1c in this clinical context and to inform future strategies for diabetes diagnosis and monitoring in patients receiving sulfasalazine, including the potential need for alternative or supplementary glucose assessment methods.

Keywords
Validation of HbA1c, Sulfasalazine, Salazopyrin, Continuous glucose monitoring, CGM, Type 2 Diabetes, Diabetes, Hemoglobin A1c, HbA1c, Type 1 Diabetes, Fasting blood glucose
Medical subject headings
Arthritis, Diabetes Mellitus, Arthritis, Rheumatoid, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07416656
Study groupRoleWhat they receive
Inflammatory arthritis with borderline HbA1cThis 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 diabetesThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of undiagnosed diabetes mellitus

    The primary outcome is the prevalence of previously undiagnosed diabetes mellitus among adults with inflammatory arthritis treated with sulfasalazine who do not have a known diagnosis of diabetes and have a borderline HbA1c value. Undiagnosed diabetes is defined based on fasting plasma glucose measurements obtained during the study, in accordance with established diagnostic criteria. The prevalence is expressed as the proportion of participants meeting the diagnostic criteria for diabetes mellitus.

    Measured: Within 14-21 days

Secondary outcomes (1)
  1. Agreement between HbA1c and CGM-derived mean glucose in sulfasalazine-treated patients

    The secondary outcome is the agreement between HbA1c and average glucose levels measured by blinded CGM in adults with inflammatory arthritis treated with sulfasalazine. Mean glucose derived from CGM over the monitoring period is compared with contemporaneous HbA1c values to evaluate whether HbA1c accurately reflects true glycaemic status in this population. The analysis includes participants with known diabetes mellitus and participants without known diabetes but with borderline HbA1c values.

    Measured: Within 14-21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start10 Mar 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07416656
Sponsor's protocol ID
1-10-72-190-25
Acronym
DIA2SULFA
Status last verified
Jun 2026
First submitted
10 Feb 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Infante M, Padilla N, Alejandro R, Caprio M, Della-Morte D, Fabbri A, Ricordi C. Diabetes-Modifying Antirheumatic Drugs: The Roles of DMARDs as Glucose-Lowering Agents. Medicina (Kaunas). 2022 Apr 21;58(5):571. doi: 10.3390/medicina58050571.

    PubMed 35629988
  • Farmacies sales of drugs. eSundhed.dk [Internet]. Available from: https://www.esundhed.dk/Emner/Laegemidler/Apotekernes-salg-af-laegemidler

  • Lindhardsen J, Ahlehoff O, Gislason GH, Madsen OR, Olesen JB, Torp-Pedersen C, Hansen PR. The risk of myocardial infarction in rheumatoid arthritis and diabetes mellitus: a Danish nationwide cohort study. Ann Rheum Dis. 2011 Jun;70(6):929-34. doi: 10.1136/ard.2010.143396. Epub 2011 Mar 9.

    PubMed 21389043
  • Baghdadi LR, Woodman RJ, Shanahan EM, Mangoni AA. The impact of traditional cardiovascular risk factors on cardiovascular outcomes in patients with rheumatoid arthritis: a systematic review and meta-analysis. PLoS One. 2015 Feb 17;10(2):e0117952. doi: 10.1371/journal.pone.0117952. eCollection 2015.

    PubMed 25689371
  • N'Dow SMS, Donnelly LA, Pearson ER, Rena G. In a cohort of individuals with type 2 diabetes using the drug sulfasalazine, HbA1c lowering is associated with haematological changes. Diabet Med. 2021 Sep;38(9):e14463. doi: 10.1111/dme.14463. Epub 2020 Dec 8.

    PubMed 33236391
  • Mitchell K, Mukhopadhyay B. Drug-Induced Falsely Low A1C: Report of a Case Series From a Diabetes Clinic. Clin Diabetes. 2018 Jan;36(1):80-84. doi: 10.2337/cd17-0005. No abstract available.

    PubMed 29382985
  • Tack CJ, Wetzels JF. Decreased HbA1c levels due to sulfonamide-induced hemolysis in two IDDM patients. Diabetes Care. 1996 Jul;19(7):775-6. doi: 10.2337/diacare.19.7.775.

    PubMed 8799639
  • Danish Society of Rheumatology. Rheumatoid arthritis - national clinical guideline [Internet]. [cited 2025 Aug 20].

  • Danish Society of Rheumatology. Sulfasalazine [Internet]. [cited 2025 Aug 20]. Available from: https://danskreumatologi.dk/laegemidler/sulfasalazin/

  • Christensen SH HN, Janukonyté J, Vestergaard EM, Samson M.. . Brug af glykeret hæmoglobin-måling i praksis. . Ugeskr Læger.183(V12200902):1-8.

  • Pant V. HbA1c Below the Reportable Range. Lab Med. 2022 Mar 7;53(2):e44-e47. doi: 10.1093/labmed/lmab082.

    PubMed 34611711

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Arthritis and Diabetes (DM), run by Klavs Würgler Hansen at 1 site in Denmark.

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 6 inclusion and 4 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 25 Jun 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 Denmark. 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 Katrine B Gørlitz, MD (0045 2421 0787, kagoer@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of undiagnosed diabetes mellitus (time frame: Within 14-21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07416656, which also lists 11 linked publications.

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 25 Jun 2026.

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