Status:

COMPLETED

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

Lead Sponsor:

Medical University of Graz

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

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.

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT00813410

Start Date

February 1 2007

End Date

December 1 2007

Last Update

December 23 2008

Active Locations (1)

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Medical University of Graz

Graz, Styria, Austria, A-8036