NCT01504620

Brief Summary

The goal of this single-center, comparative, open label, in-vitro diagnostic device performance evaluation was to investigate the performance of two sanofi-aventis BGMSs (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence (Helios).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 diabetes-mellitus

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

January 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
Last Updated

January 5, 2012

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

December 27, 2011

Last Update Submit

January 3, 2012

Conditions

Diabetes Mellitus

Keywords

diabetes mellitusblood glucose self-assessmentAccuracyIntra-Assay precisionHematocrit interference

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the blood glucose meter in comparison to a standard reference

    After start of the experiment, blood glucose will be measured by means of the test devices and blood will be drawn for assessment of venous blood glucose concentration with a standard laboratory reference method

    within 10 min up to 300 min after start of experiment

Secondary Outcomes (2)

  • Intra-Assay precision

    within 10 min up to 300 min after start of experiment

  • Hematocrit Interference (Helios)

    within 10 min up to 300 min after start of the experiment

Study Arms (2)

Sugar infusion

OTHER

Diagnostic assessment of blood glucose by means of different devices

Other: Sugar infusion

insulin infusion

EXPERIMENTAL

infusion of insulin to achieve low glucose levels

Drug: insulin infusion

Interventions

Sugar infusionOTHER

Infusion of glucose to achieve high blood glucose levels

Also known as: 5 % glucose solution
Sugar infusion
insulin infusionDRUG

i.v. infusion of insulin

Also known as: insuman rapid
insulin infusion

Eligibility Criteria

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

You may qualify if:

  • healthy subjects or patients with type 1 or type 2 diabetes
  • screening glucose levels fall into required glucose ranges
  • screening hematocrit values between 36 % to 55 %

You may not qualify if:

  • history of hypotension during blood draws
  • intake of drugs known to interfere with blood glucose readings
  • biochemical safety parameters outside of reference ranges
  • Hb \< 11 g/dL
  • lack of compliance
  • history of frequent hypoglycemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IKFE - Institute for Clinical Research and Development

Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Andreas Pfützner, MD, PhD

    IKFE Institute for Clinical Research and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2011

First Posted

January 5, 2012

Study Start

January 1, 2011

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

January 5, 2012

Record last verified: 2011-12

Locations

DE(1)