Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: insulin delivery; Device: glucose sensing

• Registration Number: NCT02359617
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-10
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
glucose sensing and insulin delivery	insulin delivery	Subcutaneous insulin delivery with an insulin pump plus glucose sensing with a continuous glucose sensor placed at the site of subcutaneous insulin delivery. In parallel, capillary glucose determinations using a conventional glucose meter as well as glucose sensing in subcutaneous, insulin-unexposed tissue using a continuous glucose sensor.
glucose sensing and insulin delivery	glucose sensing	Subcutaneous insulin delivery with an insulin pump plus glucose sensing with a continuous glucose sensor placed at the site of subcutaneous insulin delivery. In parallel, capillary glucose determinations using a conventional glucose meter as well as glucose sensing in subcutaneous, insulin-unexposed tissue using a continuous glucose sensor.

Primary Outcome Measures

Name	Time	Method
Mean absolute relative difference between sensor readings and capillary glucose readings	7 days	Mean absolute relative differences calculated by determining the mean of the absolute value of the percentage difference between paired sensor and capillary glucose concentration

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria