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NCT03870971 · ClinicalTrials.gov registry record · NA

User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)

A NA study of Diabetes Mellitus, sponsored by Sciema UG.

Completed
Registry status
NA
Development phase
543
Enrollment target
1
Study location

NCT03870971 is a NA study of Diabetes Mellitus that has completed, run by Sciema UG. The registered enrollment target is 543 participants, below the 1,865-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03870971, a NA study of Diabetes Mellitus, has completed, sponsored by Sciema UG.

COMPLETED
Registry status
NA
Development phase
543 participants
Enrollment target
1
Study location

Study Summary

Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.

Conditions Studied

Interventions

  • OTHER blood glucose measurement

Study Locations (1)

Washington

  • Rainier Clinical Research Center, Inc. - Renton

Trial Details

FieldValue
Enrollment Target 543 participants
Start Date 2019-02-04
Est. Completion 2019-08-31
Phase NA

Sponsor

Sciema UG

3 total trials

What the Registry Record Tells You About NCT03870971

The ClinicalTrials.gov registry entry for NCT03870971 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 543 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,865-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (71% lower). The listed sponsor is Sciema UG, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which blood glucose measurement is the first listed.

NCT03870971 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT03870971 about?

NCT03870971 is a clinical study titled "User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)". Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further ...

What is the current status of trial NCT03870971?

This trial is currently completed. It is a NA study. The enrollment target is 543 participants. The study started on 2019-02-04. Estimated completion is 2019-08-31.

What conditions does trial NCT03870971 study?

This clinical trial studies the following conditions: Diabetes Mellitus.

What interventions are being tested in trial NCT03870971?

The interventions under investigation include: blood glucose measurement (OTHER).

Who is sponsoring clinical trial NCT03870971?

This trial is sponsored by Sciema UG, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03870971 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.