Continuous Subcutaneous Hydrocortisone Infusion In Addison`s Disease and Type 1 Diabetes
The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications.
The majority of Addison's patients have other organ-specific autoimmune disease, which poses challenges to the replacement therapy. Of particular interest is the combination of Addison`s disease and type 1 diabetes, since cortisol affects glucose homeostasis. The clinical experience is that this subgroup of patients is difficult to treat, but very little research has been done to understand and improve their situation.
Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, and can mimic the normal diurnal cortisol rhythm. This pilot study aims to further evaluate continuous subcutaneous hydrocortisone infusion treatment in terms of metabolic effects especially glycemic control in patients with the combination of Addison`s disease and type 1 diabetes in an 5 months cross-over design open clinical pilot study.
Type 1 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Continuous Subcutaneous Hydrocortisone Infusion In Addison`s Disease and Type 1 Diabetes|
- nocturnal hypoglycemic events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]severe hypoglycemia (needs for another person's assistance, blood glucose ≤ 3.1 mmol ⁄ L or prompt recovery after oral carbohydrate, i.v glucose or glucagon administration) and insulin requirement
- o Nocturnal glycemic variability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]monitored by continuous glucose monitor system
- hormone and metabolic profile [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Hormone levels : insulin like growth factor 1, growth hormone
- Steroid metabolism: adrenocorticotropic hormone , cortisol
- Metabolic profile: fructosamine, HBA1C, lipid levels, C reactive protein , homeostasis model assessment index
- o Subjective health status [ Time Frame: 4 months ] [ Designated as safety issue: No ]Self administration of questionnaires
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Cortef
Treatment A is oral hydrocortisone replacement( Cortef 5 mg)with weight-adjusted doses as suggested by Mah et al , will take 2 months
Treatment B is continuous subcutaneous hydrocortisone infusion with the initial standard dose of 10mg/m2/24hrs. Body surface area will be calculated according to the nomogram from the formula of Du Bois and Du Bois.
This part of the study will take 2 months.
Active Comparator: Solu-cortef
This is the treatment B by continuous subcutaneous hydrocortisone infusion. Solu-cortef infusion will be given as Solu-Cortef Act-o-Vial 50mg/ml, , produced by Pfizer. Pump designed for subcutaneous insulin infusion can be used for subcutaneous administration.
Treatment A is oral hydrocortisone replacement ( Cortef 5 mg) administered according to weight-adjusted doses for 2 months
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|Contact: Katerina Simunkova, MD, Phd||+4755 email@example.com|
|Haukeland University Hospiatl||Recruiting|
|Bergen, Norway, 5021|
|Contact: Katerina Simunkova, MD, PhD firstname.lastname@example.org|
|Sub-Investigator: Kristian Løvås, MD, PhD|
|Principal Investigator: Katerina Simunkova, MD, PhD|
|Study Director:||Kristian Løvås, MD, PhD||Haukeland University Hospital|
|Principal Investigator:||Katerina Simunkova, PhD||Haukeland University Hospital|