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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Glucocorticoid-induced Hyperglycemia

Treatments: Behavioral: diet and exercise intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03018600

PekingUMCH-ZS965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 25 to 46 years old

Volunteers: No Healthy Volunteers

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;

Trial design

25 participants in 2 patient groups

1

Description:

We included 15 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) to the patients every morning at 8am for at least five days.

Treatment:

Behavioral: diet and exercise intervention

2

Description:

We included 10 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: using less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months and now treating with 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for the relapse of primary autoimmune disease for at least five days.

Treatment:

Behavioral: diet and exercise intervention