Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: insulin delivery; Device: glucose sensing

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, A-8036
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: European Commission
• Investigators: Principal Investigator: Thomeas R Pieber, MD, Medical University of Graz, Internal Medicine, Endocrinology and Metabolism

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Estimate): April 27, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: type 1 diabetes; continuous glucose sensor; subcutaneous insulin infusion; closed-loop glucose control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: Single-Port@Home-01