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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: Completed NA study of Diabetes Mellitus, sponsored by Sciema UG.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus).

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
Sciema UG

3 total trials

What the finished NCT03870971 record still lists

NCT03870971 is an interventional study that assigns participants to a tested intervention. The registered 543 participants enrollment target is mid-sized for trials with a published cap, below the 1,865-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (71% lower).

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 a single indexed study location in 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.

Similar trials for Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03870971's enrollment target sits among peer trials

543 44th of 208 higher than 165 of 208 other Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03870971, the US trial registry maintained by the National Library of Medicine. NCT03870971 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.