Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vastra Gotaland Region
• Collaborators: Åke Wibergs Stiftelse; Pilloxa; Sahlgrenska University Hospital, Sweden; The Gothenburg Society of Medicine
• Treatments: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

Men and women at age 18 to 70 years, with BMI 18-32 kg/m2 and well-defined both insulin-treated diabetes & Addison's disease for >12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg/day) for >3 months.

Exclusion Criteria:

• Any medication with other glucose lowering agents than insulin

• Any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases

• Any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility

• Any medication with oral estrogen supplementation and/or regular DHEA medication for the past 4 weeks

• Clinically significant renal dysfunction with a serum creatinine above 160 mmol/L

• Active malignancy

• Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary/pancreatic disease which in the investigator's judgement may interfere with the study assessment

• Pregnant or lactating women

• Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.