Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefan Korsatko, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00812591
First received: December 19, 2008
Last updated: October 18, 2011
Last verified: October 2011
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 20
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812591

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 of Graz, Internal Medicine, Endocrinology and Nuclear Medicine
  More Information

No publications provided

Responsible Party: Stefan Korsatko, MD, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00812591     History of Changes
Other Study ID Numbers: ZIG26
Study First Received: December 19, 2008
Last Updated: October 18, 2011
Health Authority: Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on October 23, 2014