Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

NCT ID: NCT02359617

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-03-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

glucose sensing and 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.

Group Type: EXPERIMENTAL

insulin delivery

Intervention Type: DRUG

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.

glucose sensing

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Pieber Thomas, MD

MD, Prof. of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomeas R Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Internal Medicine, Endocrinology and Metabolism

Locations

Medical University of Graz

Graz, Styria, Austria

Countries

Austria

Other Identifiers

Single-Port@Home-01

Identifier Type: -

Identifier Source: org_study_id