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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812591
• Other study ID #: ZIG26
• Status: Completed
• Phase: N/A
• First received: December 19, 2008
• Last updated: October 18, 2011
• Start date: May 2006
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio between the plasma glucose level and the glucose concentration at the subcutaneous insulin delivery site		1 day	No