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NCT02150109 · ClinicalTrials.gov registry record · NA

Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)

A NA study, sponsored by Ascensia Diabetes Care.

Completed
Registry status
NA
Development phase
372
Enrollment target

NCT02150109: Completed NA study, sponsored by Ascensia Diabetes Care.

NCT02150109 is a NA study that has completed, run by Ascensia Diabetes Care. The registered enrollment target is 372 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02150109, a NA study, has completed, sponsored by Ascensia Diabetes Care.

COMPLETED
Registry status
NA
Development phase
372 participants
Enrollment target

Study Summary

The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.

Primary Outcome

Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/-15% (\>=100 mg/dL YSI capillary plasma).

Interventions

  • DEVICE Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS
  • DEVICE Subjects WITH Diabetes Use Karajishi Contour BGMS

Trial Details

FieldValue
Enrollment Target 372 participants
Start Date 2014-06
Est. Completion 2014-06
Phase NA
Ascensia Diabetes Care

42 total trials

What the finished NCT02150109 record still lists

NCT02150109 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS is the first listed.

NCT02150109 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02150109 about?

NCT02150109 is a clinical study titled "Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)". The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.

What is the current status of trial NCT02150109?

This trial is currently completed. It is a NA study. The enrollment target is 372 participants. The study started on 2014-06. Estimated completion is 2014-06.

What interventions are being tested in trial NCT02150109?

The interventions under investigation include: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS (DEVICE), Subjects WITH Diabetes Use Karajishi Contour BGMS (DEVICE).

Who is sponsoring clinical trial NCT02150109?

This trial is sponsored by Ascensia Diabetes Care, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02150109's enrollment target sits among peer trials

372 280th of 2000 higher than 1,720 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT02150109, the US trial registry maintained by the National Library of Medicine. NCT02150109 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.