Clinical trial NCT02359617: Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: continuous glucose sensor
subcutaneous insulin infusion
closed-loop glucose control
type 1 diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2015-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study seeks to evaluate a novel treatment approach for performing continuous real-time glucose sensing and insulin delivery at the same subcutaneous tissue site.

Detailed description: The treatment of type 1 diabetes usually comprises the measurement of glucose in blood obtained by finger pricking and the administration of insulin via subcutaneous bolus injection or continuous subcutaneous infusion.

This study seeks to test a new treatment approach where glucose sensing and insulin administration are combined and performed at a single subcutaneous tissue site (single-port treatment approach). A single-port device consisting of a continuous glucose sensor and an insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period. The performance of the single-port device is assessed by comparing the obtained glucose readings with those of a blood glucose meter and an additionally worn control sensor.

Eligibility 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

Primary outcomes:
measure: Mean absolute relative difference between sensor readings and capillary glucose readings
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz, Internal Medicine, Endocrinology and Metabolism
name: Thomeas R Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References: