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NCT01268488 · ClinicalTrials.gov registry record · NA

Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

A NA study, sponsored by Ascensia Diabetes Care.

Completed
Registry status
NA
Development phase
98
Enrollment target

NCT01268488: Completed NA study, sponsored by Ascensia Diabetes Care.

NCT01268488 is a NA study that has completed, run by Ascensia Diabetes Care. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01268488, a NA study, has completed, sponsored by Ascensia Diabetes Care.

COMPLETED
Registry status
NA
Development phase
98 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.

Primary Outcome

Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5 to 20% (for reference BG results \>=75mg/dL) of the reference method results.

Interventions

  • DEVICE Ninja 2 Investigational Blood Glucose Meter

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2010-12
Est. Completion 2010-12
Phase NA
Ascensia Diabetes Care

42 total trials

What the finished NCT01268488 record still lists

NCT01268488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Ninja 2 Investigational Blood Glucose Meter is the first listed.

NCT01268488 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01268488 about?

NCT01268488 is a clinical study titled "Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting". The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.

What is the current status of trial NCT01268488?

This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2010-12. Estimated completion is 2010-12.

What interventions are being tested in trial NCT01268488?

The interventions under investigation include: Ninja 2 Investigational Blood Glucose Meter (DEVICE).

Who is sponsoring clinical trial NCT01268488?

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 NCT01268488's enrollment target sits among peer trials

98 922nd of 2000 higher than 1,078 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 NCT01268488, the US trial registry maintained by the National Library of Medicine. NCT01268488 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.