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Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

ConditionsDiabetes MellitusAdrenal InsufficiencyPolyglandular Autoimmune Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVastra Gotaland Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • OD dual-release Hydrocortisone

    Drug

    Treatment with once-daily dual-release hydrocortisone

  • TID Hydrocortisone

    Drug

    Treatment with thrice-daily conventional immediate-release hydrocortisone

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Once-daily dual-release hydrocortisoneExperimental treatment 1 intervention
Group B: Thrice-daily conventional immediate-release hydrocortisoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

glycemic variability

glycemic variability

Time frame
4 weeks

Secondary outcomes

1

HbA1c

HbA1c

Time frame
4 weeks
2

Time in range (glucose)

Time in range (glucose)

Time frame
4 weeks
3

Time above range (glucose)

Time above range (glucose)

Time frame
4 weeks
4

Time below range (glucose)

Time below range (glucose)

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

The Swedish Society of Medicine

Collaborator

Åke Wibergs Stiftelse

Collaborator

Sahlgrenska University Hospital

Collaborator

Pilloxa

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: