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

NCT00812591 | Completed DMC

• 1 other identifier: ZIG26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Ratio between the plasma glucose level and the glucose concentration at the subcutaneous insulin delivery site

  1 day

Interventions

OGTT and CLAMP PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, A-8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucose Tolerance Test; Constriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Thomas R. Pieber, MD

  Medical University of Graz, Internal Medicine, Endocrinology and Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: May 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

AU (1)