Effect of once vs twice daily Administration of corticosteroids on blood Glucose in patients with Anca-Vasculitis measured by continuous blood glucose monitoring - a pilot study

Phase 4

Recruiting

• Conditions: Anca VasculitisORPHA 93126; E14; N05.7; Unspecified diabetes mellitus

• Registration Number: DRKS00018969
• Lead Sponsor: niversitätsklinikum für Innere MedizinAbteilung für Nephrologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

* Written agreement to participate in the study after detailed explanation of the study
* Male or female patients
* New diagnosis of ANCA-associated vasculitis or a relapse of a known ANCA vasculitis
* Age: =18-80 years at the time of biopsy
* Aprednislon dose of 1mg/kg body weight at the time of inclusion
* Willing to wear a CGM system for the duration of the study and receive insulin therapy according to need

Exclusion Criteria

* Known diabetes mellitus
* Women capable of giving birth who are pregnant, breastfeeding, wish to become pregnant or do not use adequate contraception.
* Skin changes or concomitant circumstances that prevent the placement of a glucose sensor in the investigator's assessment (e.g. scar tissue)
* Current participation in another clinical trial that would affect study results
* Relevant acute or chronic disease that, in the investigator's estimation, could affect the patient's safety or affect the study results.
* Patient's inability to follow study procedures as required
* Inability of the patient to understand the consent form

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean time in target range (70-180mg/dl) measured by blinded continuous glucose measurement (CGM).