Continuous Glucose Monitoring on Patients With Active Autoimmune Diseases Following High-dose Predisone Treatment

Completed

• Conditions: Glucocorticoid-induced Hyperglycemia

• Registration Number: NCT03018600
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Glucocorticoid is widely used in clinical treatment. Recently, there was research about glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active autoimmune diseases. Through this prospective trial, the investigators wanted to know the blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or equivalent) in young patients (30-40 years) with active autoimmune diseases with or without low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for 72 hours to get a better understanding of the glucose levels.

Detailed Description

As known to all, the dosage and duration of glucocorticoid influences the glucose levels in different diseases. Continuous glucose monitoring becomes a newly effective technology to better understand the glucose level. In this study,the investigators enrolled 25 patients with certain active autoimmune diseases during high-dosage glucocorticoid therapy at Peking Union Medical College Hospital. It was done by monitoring three-day continuous glucose levels by holding continuous glucose monitoring system underneath the skin, which helped to show a unique picture of fluctuations. The participants were divided into two groups according to the glucocorticoid therapy. Group 1 enrolled subjects who were newly commenced 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for at least five days. Group 2 enrolled subjects who had underwent less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months but treated with high-dose glucocorticoid for the relapse during the study This finding is useful for the suitable treatment to control the hyperglycemia in young patients.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2017-01-07
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Young patients with exacerbation of autoimmune disease, requiring 1-2mg/kg/day prednisone or equivalent for treatment;
• could undergo <15mg/kg/day prednisone or equivalent glucocorticoid maintenance in the previous three months;

Exclusion Criteria

• patients with history of diabetes;
• patients with severe organ dysfunction or failure;
• patients with febrile conditions;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
glucose values of 24 hours (mmol/L);	72 hours CGMS monitoring

Secondary Outcome Measures

Name	Time	Method
the amounts of patients developing hyperglycemia	72 hours CGMS monitoring