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Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients
This study is ongoing, but not recruiting participants.
Sponsored by: Medical University of Graz
Information provided by: Medical University of Graz
ClinicalTrials.gov Identifier: NCT00812591
  Purpose

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


Condition Intervention
Type 1 Diabetes
Procedure: OGTT and CLAMP

MedlinePlus related topics: Diabetes Diabetes Type 1
Drug Information available for: Insulin Dextrose
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Open Label, Single Group Assignment
Official Title: Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Ratio between the plasma glucose level and the glucose concentration at the subcutaneous insulin delivery site [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: OGTT and CLAMP

    Oral Glucose Tolerance Test (OGTT):

    Oral glucose tolerance test combined with subcutaneous insulin delivery and glucose sampling using a single microdialysis or microperfusion probe.

    Hyperinsulinemic euglycemic clamp (CLAMP):

    Hyperinsulinemic euglycemic clamp with simultaneous subcutaneous insulin delivery and glucose sampling using microdialysis and microperfusion probe.

Detailed Description:

Current treatment of in type 1 diabetes 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 subcutaneous infusion. This treatment could be simplified if there were a stable ratio between blood glucose concentration and tissue glucose level at the site of insulin delivery so that tissue glucose levels could be used to estimate blood glucose levels, thereby circumventing the need for fingerstick blood glucose monitoring.

The aim of this study is to ascertain whether a stable ratio between the blood glucose concentration and the glucose levels at the tissue site of insulin infusion exists when this tissue site is exposed to variable insulin infusion rates. To achieve this, microdialysis and microperfusion probes are applied in healthy and type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site during euglycemic clamps and oral glucose tolerance tests.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus patients aged 18 - 65
  • Healthy subjects aged 18 - 65
  • Informed consent obtained before any trial-related activities.

Diabetic subjects:

  • C-peptide negative (≤ 0.05 nmol/L)
  • HbA1c (glycosylated haemoglobin A1c) < 10%

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
  • Subject with mental incapacity or language barriers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812591

Locations
Austria, Styria
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 of Graz, Internal Medicine, Endocrinology and Nuclear Medicine
  More Information

Responsible Party: Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine ( Univ. Prof. Dr. Thomas Pieber )
Study ID Numbers: ZIG26
Study First Received: December 19, 2008
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00812591  
Health Authority: Austria: Agency for Health and Food Safety

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009