Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

Medical University of Graz

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: insulin delivery; Device: glucose sensing

Study type: Interventional

Funder types: Other

Identifiers

NCT02359617

Single-Port@Home-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

glucose sensing and insulin delivery

Experimental group

Description:

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.

Treatment:

Device: glucose sensing

Drug: insulin delivery