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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00813410
First received: December 20, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Procedure: Glucose measurement at the sc. insulin delivery site

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • glucose concentration at the subcutaneous insulin delivery site [ Time Frame: 20 hours ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Glucose measurement at the sc. insulin delivery site
    Overnight fasting and oral glucose tolerance test (OGTT) combined with simultaneous subcutaneous insulin delivery and glucose sampling using a single microdialysis or microperfusion probe.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813410

Locations
Austria
Medical University of Graz
Graz, Styria, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R. Pieber, MD Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine
  More Information

No publications provided

Responsible Party: Univ. Prof. Dr. Thomas Pieber, Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine
ClinicalTrials.gov Identifier: NCT00813410     History of Changes
Other Study ID Numbers: ZIG96
Study First Received: December 20, 2008
Last Updated: December 20, 2008
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013