Type 1 Diabetes
Conditions
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 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.
Interventions
PROCEDUREGlucose 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.
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glucose concentration at the subcutaneous insulin delivery site | 20 hours |
Countries
Austria
Outcome results
None listed