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Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

NCT05716607 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-04-30

No results posted yet for this study

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

Interventions

DRUG

OD dual-release Hydrocortisone

Treatment with once-daily dual-release hydrocortisone

DRUG

TID Hydrocortisone

Treatment with thrice-daily conventional immediate-release hydrocortisone

Sponsors & Collaborators

  • The Swedish Society of Medicine

    collaborator OTHER

  • Åke Wibergs Stiftelse

    collaborator UNKNOWN

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Pilloxa

    collaborator INDUSTRY

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Dimitrios Chantzichristos, MD PhD · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05716607 on ClinicalTrials.gov