ASSESSMENT OF INFUSION SET SURVIVAL OF THE NEWLY DEVELOPED LANTERN CATHETER IN TYPE 1 DIABETES BY GLUCOSE CLAMP TECHNIQUE (A PILOT STUDY)
- Conditions
- E10Type 1 diabetes mellitus
- Registration Number
- DRKS00013263
- Lead Sponsor
- ConvaTec B2BR&D and Business Development Unomedical a/s
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- 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 insulin aspart or glulisine 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
- Stable body weight in the last 3 months prior to study start (change in body weight <5%)
- Non-insulin hypoglycemic agents
- Regular use of insulin lispro for diabetes management
- Diabetic ketoacidosis during the previous 12 months
- Severe hypoglycemia 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
- Smoker (> 5 cigarettes per day)
- 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 tmax(GIR), time to maximum glucose infusion rate on days 1, 4 and 7 of catheter wear-time
- Secondary Outcome Measures
Name Time Method