Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Adipose Tissue of Diabetic Patients
NCT ID: NCT00813410
Last Updated: 2008-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2007-02-28
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine
Principal Investigators
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Thomas R. Pieber, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine
Locations
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Medical University of Graz
Graz, Styria, Austria
Countries
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Other Identifiers
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ZIG96
Identifier Type: -
Identifier Source: org_study_id