Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Adipose Tissue of Diabetic Patients

December 20, 2008 updated by: Medical University of Graz

A Single Center, Open-Labeled Exploratory Study to Evaluate a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue of Type-1 Diabetic Patients

The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glucose management in type 1 diabetic patients comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or continuous subcutaneous infusion.

The present study seeks to test an alternative treatment approach that combines glucose measurement and insulin delivery at a single subcutaneous tissue site, thereby circumventing the need for fingerstick blood glucose monitoring. Microperfusion and microdialysis probes are applied in type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site. The feasibility of estimating blood glucose concentrations from the glucose levels measured at the subcutaneous insulin delivery site is then assessed during an overnight fast and an oral glucose tolerance test.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Type 1 diabetes mellitus patients aged 18 - 65
  • C-peptide negative (≤ 0.05 nmol/L)
  • HbA1c (glycosylated haemoglobin A1c) < 10%
  • Body Mass Index: 21 - 30 kg/m2
  • Informed consent obtained before any trial-related activities.

Exclusion Criteria:

  • Severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy)
  • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
  • Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator
  • Treatment with drugs that could interfere with glucose metabolism and subcutaneous insulin absorption
  • Subject with mental incapacity or language barriers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glucose concentration at the subcutaneous insulin delivery site
Time Frame: 20 hours
20 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Thomas R. Pieber, MD, Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 20, 2008

First Submitted That Met QC Criteria

December 20, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2008

Last Update Submitted That Met QC Criteria

December 20, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIG96

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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