NCT02359617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

January 28, 2015

Last Update Submit

April 24, 2015

Conditions

Type 1 Diabetes

Keywords

continuous glucose sensorsubcutaneous insulin infusionclosed-loop glucose controltype 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

glucose sensing and insulin delivery

EXPERIMENTAL

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 deliveryDevice: glucose sensing

Interventions

insulin deliveryDRUG

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 and insulin delivery
glucose sensingDEVICE

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

glucose sensing and insulin delivery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, A-8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Thomeas R Pieber, MD

    Medical University of Graz, Internal Medicine, Endocrinology and Metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Prof. of Medicine

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 10, 2015

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

AU(1)