MedDataX Logo

System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus

NCT ID: NCT02290067

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

blood glucose monitoring system system accuracy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omnitest 3

Blood glucose monitoring system

Group Type ACTIVE_COMPARATOR

Blood glucose monitoring system (Omnitest 3)

Intervention Type DEVICE

Omnitest 5

Blood glucose monitoring system

Group Type EXPERIMENTAL

Blood glucose monitoring system (Omnitest 5)

Intervention Type DEVICE

Omnitest 5D

Blood glucose monitoring system

Group Type EXPERIMENTAL

Blood glucose monitoring system (Omnitest 5D)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood glucose monitoring system (Omnitest 3)

Intervention Type DEVICE

Blood glucose monitoring system (Omnitest 5)

Intervention Type DEVICE

Blood glucose monitoring system (Omnitest 5D)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with type 1 or type 2 diabetes and healthy subjects
* 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) or insulin pump therapy (continuous subcutaneous insulin infusion)

Exclusion Criteria

* 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 patient caused by the test
* Mental incapacity or language barriers precluding adequate compliance with the test procedures
* 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 patient caused by the test
* Legal incompetence or limited legal competence
* Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
* For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role collaborator

B. Braun Melsungen AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nina Jendrike, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft

Ulm, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IDT-1340-BE

Identifier Type: OTHER

Identifier Source: secondary_id

OPM-G-V-1203

Identifier Type: -

Identifier Source: org_study_id