Effects of pump-type and catheter age on insulin absorptio

Completed

• Conditions: Diabetes Mellitus Type 1; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN83549327
• Lead Sponsor: Academic Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Aged 18 years or above
2. Diagnosed with Type 1 diabetes mellitus (DM) at least 6 months according to the WHO definition
3. Treated with CSII or MDII for at least 3 months
4. Body Mass Index (BMI) <35 kg/m²
5. Willing and able to wear the study pump devices for the duration of the study and undergo all study procedures
6. Willing to use insulin lispro for the duration of the trial
7. HbA1c measured during the last three months between 6 and 10%
8. Signed informed consent form prior to study entry
9. Using <66 insulin units per day on average

Exclusion Criteria

1. Patient is pregnant, or breast feeding during the period of the study
2. Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
3. Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient?s safety or successful participation in the study
4. Patient is actively enrolled in another clinical trial or took part in a study within the past 30 days
5. Known adrenal gland problem, pancreatic tumour, or insulinoma
6. Inability of the patient to comply with all study procedures
7. Inability of the patient to understand the patient information
8. Patient donated blood in the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified