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Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
insulin delivery
glucose sensing
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes focused on measuring continuous glucose sensor, subcutaneous insulin infusion, closed-loop glucose control, type 1 diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

glucose sensing and insulin delivery

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 28, 2015
Last Updated
April 24, 2015
Sponsor
Medical University of Graz
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02359617
Brief Title
Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz
Collaborators
European Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
continuous glucose sensor, subcutaneous insulin infusion, closed-loop glucose control, type 1 diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glucose sensing and insulin delivery
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
insulin delivery
Intervention Description
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
Device
Intervention Name(s)
glucose sensing
Intervention Description
Glucose sensing with a continuous glucose sensor (Dexcom G4 Platinum Sensor; Dexcom Inc., San Diego, USA) placed at the site of subcutaneous insulin delivery.
Primary Outcome Measure Information:
Title
Mean absolute relative difference between sensor readings and capillary glucose readings
Description
Mean absolute relative differences calculated by determining the mean of the absolute value of the percentage difference between paired sensor and capillary glucose concentration
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomeas R Pieber, MD
Organizational Affiliation
Medical University of Graz, Internal Medicine, Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
A-8036
Country
Austria

12. IPD Sharing Statement

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Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

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