NCT05716607

Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of INS.CORT trial is, by studying glycemic variability in a well-defined patient group with both insulin \& hydrocortisone (patients with concomitant insulin-treated diabetes \& Addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin \& glucocorticoids.

Conditions

• Diabetes Mellitus
• Adrenal Insufficiency
• Polyglandular Autoimmune Syndrome

Interventions

Type	Name	Description
DRUG	OD dual-release Hydrocortisone	Treatment with once-daily dual-release hydrocortisone
DRUG	TID Hydrocortisone	Treatment with thrice-daily conventional immediate-release hydrocortisone

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2023-02-08
• Last updated: 2024-04-30

Locations

1 site across 1 country: Sweden