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

Medical University of Graz

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Procedure: Glucose measurement at the sc. insulin delivery site

Study type

Interventional

Funder types

Other

Identifiers

NCT00813410

ZIG96

Details and patient eligibility

About

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.

Full 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 bolus injection or continuous subcutaneous infusion.

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.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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
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