COMPARISON OF THE NEWLY DEVELOPED ARTIFICIALLY CLOGGED LANTERN CATHETER VS. STANDARD INFUSION SET IN TYPE 1 DIABETES UNDER REAL-LIFE CONDITIONS
- Conditions
- E10Type 1 diabetes mellitus
- Registration Number
- DRKS00017826
- Lead Sponsor
- ConvaTec B2B, R&D and Business Development, Unomedical a/s
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Informed consent obtained after being advised of the nature of the study
-Male or female aged =18 years
-Type 1 diabetes for at least 12 months according to the WHO definition
-Regular use of insulins aspart, glulisine or lispro for diabetes management
-C-peptide <0.3nmol/L
-Treatment with continuous subcutaneous insulin infusion (CSII) for at least 6 months (an interruption of 3 months is allowed)
-Body Mass Index (BMI) 20-28kg/m²
-Willing and able to wear a CGM device and use the study specific insulin pump and study specific catheters for the duration of the study and undergo all study procedures
-HbA1c =86 mmol/mol
-Patients able to use 6 mm infusion cannulas
-Non-insulin hypoglycemic agents
-Use of regular human insulin for diabetes management
-Diabetic ketoacidosis during the previous 12 months
-Severe hypoglycaemia requiring third party help, hospitalization or emergency room visit during the previous 12 months
-Hypoglycemia unawareness
-Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
-Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator (e.g. scar tissue)
-History of bleeding disorder
-Current participation in another clinical study
-Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator
-Lipodystrophy
-Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
-Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen that in the opinion of the Investigator would compromise the subject’s safety or successful participation in the study
-Known adrenal gland problem, pancreatic tumour, or insulinoma
-Inability of the subject to comply with all study procedures
-Inability of the subject to understand the patient information
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve (AUC) of the 24-hours CGM-profile
- Secondary Outcome Measures
Name Time Method