Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359617
• Other study ID #: Single-Port@Home-01
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: April 24, 2015
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• insulin delivery
Subcutaneous insulin (100 U/ml, NovoRapid®; Novo Nordisk, Bagsvaerd, Denmark) delivery with an insulin pump (Vibe-TM; Animas Corp., West Chester, PA, USA) and an insulin infusion cannula (SOF-SET MICRO QR 6mm; Medtronic MiniMed, USA) placed at the same site as the continuous glucose sensor.

Device:
• glucose sensing
Glucose sensing with a continuous glucose sensor (Dexcom G4 Platinum Sensor; Dexcom Inc., San Diego, USA) placed at the site of subcutaneous insulin delivery.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	European Commission

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absolute relative difference between sensor readings and capillary glucose readings	Mean absolute relative differences calculated by determining the mean of the absolute value of the percentage difference between paired sensor and capillary glucose concentration	7 days	No

External Links

•   Medical University of Graz