Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes mellitus, type 1, insulin infusion systems, continuous intraperitoneal insulin infusion, cross-over studies
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes mellitus Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week. Exclusion Criteria: renal function impairment: creatinin ≥ 150 micromol/L or a creatinin clearance < 50 ml/min Cardiac problems: decompensated heart failure (NYHA III and IV); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months Known or suspected allergy against insulin or any component of the composition Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past. Severe untreated proliferative retinopathy. Insufficient knowledge of the Dutch language to understand the requirements of the study. Current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year. Substance abuse, other than nicotine A history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma Participation in other trials, involving investigational products within 30 days prior to trial entry. Plans to engage in activities which require them to go below 25 feet below sea level. Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results.
Sites / Locations
- Isala Klinieken
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CIPII
CSII/ MDI
Intraperitoneal insulin infusion by means of an implanted insulin pump
Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI)