Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

• Register: ClinicalTrials.gov
• Last refreshed on: 4 May 2015
• Main ID: NCT02359617
• Date of registration: 28/01/2015
• Prospective Registration: No
• Primary sponsor: Medical University of Graz
• Public title: Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration
• Scientific title: Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration: Evaluation of a Novel Single-Port Treatment Approach in Type 1 Diabetic Patients During a 1-Day Stay in a Clinical Research Center and a 6-Day Period at Home
• Date of first enrolment: February 2013
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02359617
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Thomeas R Pieber, MD
• Affiliation: Medical University of Graz, Internal Medicine, Endocrinology and Metabolism

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 to 65 years of age, both inclusive

- Type 1 diabetes treated with Continuous Subcutaneous Insulin Infusion (CSII)

- HbA1C < 10%

- Signed informed consent before any study-related activities

Exclusion Criteria:

- Severe acute diseases

- Clinically overt diabetic complications

- Mental incapacity, unwillingness or language barriers precluding adequate
understanding or co-operation

- Taking of any vasoactive substances or anticoagulation medication

- Diseases of the skin which could interfere with application of the catheters and
Sensors as judged by the investigator

- Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate
contraception.

- Increased tendency towards development of hypoglycaemia

- Any disease or condition which the investigator or treating physician feels would
interfere with the trial or the safety of the subject

- Concurrent participation in another study



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Device: glucose sensing

Drug: insulin delivery

Primary Outcome(s)

Mean absolute relative difference between sensor readings and capillary glucose readings [Time Frame: 7 days]

Secondary ID(s)

Single-Port@Home-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Commission