E10
Conditions
Interventions
Group 1: CSII Therapy using the newly developed, artificially clogged Lantern catheter for 72 hours
Group 2: CSII Therapy using the conventional insulin infusion catheter for 72 hours
Sponsors
ConvaTec B2B, R&D and Business Development, Unomedical a/s
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of the 24-hours CGM-profile | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous glucose monitoring total and over wear-time of the newly developed, artificially clogged Lantern catheter vs. the conventional insulin infusion catheter: - Time in target (70-180mg/dL (3.9-10.0mmol/L)) - Time in hyperglycemia (>180mg/dL (>10.0mmol/L)) - Time in hypoglycemia (300mg/dL (>16.7mmol/L) - Positive capillary ketone levels >0.6mmol/L - Ketoacidosis - Severe hypoglycemia (BG <40mg/dL (<2.2mmol/L) or hypoglycemia requiring third party help) - Adverse events - Capillary blood glucose | — |
Countries
Austria
Contacts
Public ContactTina Pöttler
Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz
Outcome results
None listed