NCT02439177

Brief Summary

The aim of this study is to determine the System Accuracy and User Performance evaluation of the mentioned BGM systems by gaining a sufficient amount of measured data from capillary blood.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

Same day

First QC Date

April 30, 2015

Last Update Submit

August 20, 2015

Conditions

Diabetes

Keywords

Blood glucose monitoring systemSystem Accuracy

Outcome Measures

Primary Outcomes (2)

  • System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment

    up to 7 hours

  • User Performance of blood glucose monitoring system indicated by patient

    up to 7 hours

Study Arms (2)

Omnitest 3

EXPERIMENTAL

Blood glucose monitoring system

Device: Blood glucose monitoring system (Omnitest 3)

Omnitest 5

EXPERIMENTAL

Blood glucose monitoring system

Device: Blood glucose monitoring system (Omnitest 5)

Interventions

Blood glucose monitoring system (Omnitest 3)DEVICE
Omnitest 3
Blood glucose monitoring system (Omnitest 5)DEVICE
Omnitest 5

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects with type 1 or type 2 diabetes, for the evaluation of System Accuracy also healthy subjects
  • Age ≥ 18
  • Signed and dated informed consent form
  • For small modifications of the insulin doses to achieve certain blood glucose values (System Accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy - I.C.T.) or insulin pump therapy (continuous subcutaneous insulin infusion - C.S.I.I.)

You may not qualify if:

  • Pregnancy or lactation period
  • Severe acute illness that, in the opinion of the investigating physician, might confound the results of the test or which could result in a risk to the subject caused by the test.
  • Severe chronic illness besides Diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the subject caused by the test.
  • Mental incapacity or language barriers precluding adequate compliance with the test procedures
  • Legal incompetence or limited legal competence
  • Dependency from the Sponsor or the clinical Investigator (e.g. co-workers of the Sponsor or the clinical research centre)
  • For User Performance evaluation: Subjects having participated in a study with Omnitest® 5 before.
  • For System Accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease or impaired hypoglycaemia awareness
  • Anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 8, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

DE(1)