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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Glucose measurement at the sc. insulin delivery site

About this trial

This is an interventional basic science trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Medical University of Graz

Outcomes

Primary Outcome Measures

glucose concentration at the subcutaneous insulin delivery site

Secondary Outcome Measures

Full Information

NCT ID

NCT00813410

First Posted

December 20, 2008

Last Updated

December 20, 2008

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT00813410

Brief Title

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

Official Title

A Single Center, Open-Labeled Exploratory Study to Evaluate a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue of Type-1 Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Graz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Glucose measurement at the sc. insulin delivery site

Intervention Description

Overnight fasting and oral glucose tolerance test (OGTT) combined with simultaneous subcutaneous insulin delivery and glucose sampling using a single microdialysis or microperfusion probe.

Primary Outcome Measure Information:

Title

glucose concentration at the subcutaneous insulin delivery site

Time Frame

20 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas R. Pieber, MD

Organizational Affiliation

Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Graz

City

Graz

State/Province

Styria

ZIP/Postal Code

A-8036

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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