NCT00813410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

10 months

First QC Date

December 20, 2008

Last Update Submit

December 20, 2008

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • glucose concentration at the subcutaneous insulin delivery site

    20 hours

Interventions

Glucose measurement at the sc. insulin delivery sitePROCEDURE

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, A-8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Thomas R. Pieber, MD

    Medical University 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

Study Record Dates

First Submitted

December 20, 2008

First Posted

December 23, 2008

Study Start

February 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 23, 2008

Record last verified: 2008-12

Locations

AU(1)