NCT02290067

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable diabetes

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

October 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1 month

First QC Date

October 22, 2014

Last Update Submit

December 19, 2014

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 6 hours

  • User performance of blood glucose monitoring systems indicated by patient [questionnaire]

    up to 4 hours

Study Arms (3)

Omnitest 3

ACTIVE COMPARATOR

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)

Omnitest 5D

EXPERIMENTAL

Blood glucose monitoring system

Device: Blood glucose monitoring system (Omnitest 5D)

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • 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)

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nina Jendrike, Dr. med.

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

    PRINCIPAL INVESTIGATOR

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

October 22, 2014

First Posted

November 13, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

DE(1)