NCT01407315

Brief Summary

Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe. Different meal/hypo procedures will be performed at the study centre.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1 month

First QC Date

May 23, 2011

Last Update Submit

April 19, 2012

Conditions

Type 1 Diabetes

Keywords

Continuous subcutaneous glucose monitoringType 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the GlucoMenDay

    Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD

    1 week

Secondary Outcomes (1)

  • Safety of the GlucoMenDay System

    1 week

Study Arms (2)

GlucoMenDay - Multiple sampling (A)

EXPERIMENTAL
Device: GlucoMenDay

GlucoMenDay - Meal/Insulin test (B)

EXPERIMENTAL
Device: GlucoMenDay

Interventions

GlucoMenDayDEVICE

Subjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio. An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed. This procedure can be performed on days 3-4 of monitoring; each subject randomized to Procedure A undergoes this procedure once.

Also known as: Continuous Glucose Monitoring
GlucoMenDay - Multiple sampling (A)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis of type-1-diabetes
  • Ability to provide informed consent
  • Age 18-75 years

You may not qualify if:

  • Subjects under anti-coagulant treatments
  • Alcoholism
  • Body mass index (BMI) \> 32 kg/m2
  • Inability to adhere to the protocol or to attend the required follow- up visits and tests
  • Diseases or conditions of the abdominal wall which, in the opinion of Clinician might contraindicate the insertion of the hypodermic needle into the subcutaneous tissue
  • Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
  • Subjects currently participating in a clinical study
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Thomas R. Pieber, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Prof. of Medicine

Study Record Dates

First Submitted

May 23, 2011

First Posted

August 2, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

AU(1)