INSCORT: Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

Vastra Gotaland Region (Other)
Overall Status
Not yet recruiting ID
The Gothenburg Society of Medicine (Other), Åke Wibergs Stiftelse (Other), Sahlgrenska University Hospital, Sweden (Other), Pilloxa (Industry)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: OD dual-release Hydrocortisone
  • Drug: TID Hydrocortisone

Study Design

Study Type:
Anticipated Enrollment :
16 participants
Intervention Model:
Crossover Assignment
Intervention Model Description:
Single-center, randomized, open-label, two-period cross-over trialSingle-center, randomized, open-label, two-period cross-over trial
None (Open Label)
Primary Purpose:
Official Title:
Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Once-daily dual-release hydrocortisone

Drug: OD dual-release Hydrocortisone
Treatment with once-daily dual-release hydrocortisone
Other Names:
  • Once-daily dual-release hydrocortisone
  • Active Comparator: Thrice-daily conventional immediate-release hydrocortisone

    Drug: TID Hydrocortisone
    Treatment with thrice-daily conventional immediate-release hydrocortisone
    Other Names:
  • Thrice-daily conventional immediate-release hydrocortisone
  • Outcome Measures

    Primary Outcome Measures

    1. glycemic variability [4 weeks]

      glycemic variability

    Secondary Outcome Measures

    1. HbA1c [4 weeks]


    2. Time in range (glucose) [4 weeks]

      Time in range (glucose)

    3. Time above range (glucose) [4 weeks]

      Time above range (glucose)

    4. Time below range (glucose) [4 weeks]

      Time below range (glucose)

    5. Cortisol exposure-time profile [4 weeks]

      Cortisol exposure-time profile

    6. systolic blood pressure [4 weeks]

      systolic blood pressure in sitting position

    7. diastolic blood pressure [4 weeks]

      diastolic blood pressure in sitting position

    8. ADDIQoL [4 weeks]

      questionnaire: the Addison-specific quality-of-life (ADDIQoL) The AddiQoL is a 36-item questionnaire; each item contains six scoring categories. Twenty-five items are negative Health-Related Quality of Life (HRQoL) statements that need to be reversed for questionnaire scoring; thus, a higher score indicates a higher level of HRQoL.

    9. PGWB [4 weeks]

      questionnaire: the Psychological General Well-Being (PGWB) index The Psychological General Well-Being Index (PGWBI) is a measure of the level of subjective psychological well-being. In detail, it assesses self-representations of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress and thus captures what we could call a subjective perception of well-being. Consisting of 22 standardized items (6 items for the short form), the tool produces a single measure of psychological well-being. The full measure also provides sub-scales to assess the following domains: anxiety, depression, positive well-being, self-control, general health, and vitality.

    10. FIS [4 weeks]

      questionnaire: the Fatigue Impact Scale (FIS) The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning minimum and maximum values, and whether higher scores mean a better or worse outcome. Higher scores mean a worse outcome. Min 0 points, max 160 points.

    11. FOSQ [4 weeks]

      questionnaire: the Functional Outcomes of Sleep Questionnaire (FOSQ) Disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. Name of categories assessed: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). Higher scores mean a better outcome. Min 0 points, max 120 points.

    12. Fever [4 weeks]

      Incidence of infections with high fever (patients judgement)

    13. CD16 [4 weeks]

      immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble CD16

    14. ADAM17 [4 weeks]

      immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble ADAM17

    15. transcriptomics [4 weeks]

      RNA sequencing for large-scale study of gene expression in circulation

    16. microRNAs [4 weeks]

      large-scale study of microRNAs in circulation

    17. proteomics [4 weeks]

      large-scale study of proteomes (proteins produced in study subjects)

    18. metabolomics [4 weeks]

      large-scale study of metabolome (metabolites produced in study subjects)

    19. hsCRP fibrinogen, immunoglobulin [4 weeks]

      High-sensitivity C-reactive Protein (laboratory measurement)

    20. SR [4 weeks]

      erythrocyte sedimentation rate (laboratory measurement)

    21. fibrinogen [4 weeks]

      fibrinogen (laboratory measurement)

    22. immunoglobulins [4 weeks]

      immunoglobulin levels in fem klasser: IgA, IgD, IgE, IgG och IgM

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    Site City State Country Postal Code
    1 Sahlgrenska University Hospital Gothenburg Sweden

    Sponsors and Collaborators

    • Vastra Gotaland Region
    • The Gothenburg Society of Medicine
    • Åke Wibergs Stiftelse
    • Sahlgrenska University Hospital, Sweden
    • Pilloxa


    • Principal Investigator: Dimitrios Chantzichristos, MD PhD, Sahlgrenska University Hospital, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    DimitriosChantzichristos, Principal Investigator, Vastra Gotaland Region Identifier:
    Other Study ID Numbers:
    • INS.CORT
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by DimitriosChantzichristos, Principal Investigator, Vastra Gotaland Region
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2023