Status:
COMPLETED
Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 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 combining insulin delivery and glucose sensing at a single subcutaneous tissue site.
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00812591
Start Date
May 1 2006
End Date
March 1 2011
Last Update
October 19 2011
Active Locations (1)
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1
Medical University of Graz
Graz, Styria, Austria, A-8036