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Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose
NCT00741390 · View on ClinicalTrials.gov ↗
Study Summary
The procurement of blood for SMBG, usually via a finger stick, is considered by many patients to be the most painful portion of diabetes therapy. This has led to the marketing of smaller gauge lancets, lancing devices with variable depth settings and blood glucose sensors that require less blood for measurement. In this study, two main outcomes were evaluated: The first, which was assessed at Visit 1, was whether specific combinations of lancets and lancing devices would yield sufficient blood volume to allow valid assessment of diabetic subjects' glucose levels. The other outcome, assessed at Visit 2, was the level of pain perceived by subjects during lancing with specific combinations of lancets and lancing devices. During Visit 2, pain assessment was done using a Visual Analog Scale and such that for each lancet/lancing device, the lowest lancing device setting that yielded a valid BG reading for each subject during Visit 1 was used. A third outcome measure, overall comfort with lancing, was also assessed at Visit 2. A total of 5 combinations of lancets and lancing devices were evaluated. These were as follows: * BD/33G = BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) * OTM/33G =OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) * OTM/28G =OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) * OTU/28G = OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) * ACC/28G= Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip) After enrollment and qualification, subjects were assigned to one of 4 intervention arms. The arm assignment deter
Conditions Studied
Interventions
- DEVICE BD/33G
- DEVICE OTM / 33G
- DEVICE OTU/28G
- DEVICE ACC/28G
- DEVICE OTM/28G
Study Locations (4)
New Jersey
- TKL Research, Inc. — Carlstadt
- TKL Research, Inc — Paramus
- TKL Research, Inc. — Ramsey
Colorado
- Thomas J. Stephens & Associates — Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2008-08 |
| Est. Completion | 2008-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00741390
The ClinicalTrials.gov registry entry for NCT00741390 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Becton, Dickinson and Company, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 5 interventions — of which BD/33G is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00741390 reports 4 study locations spanning 2 distinct geographic areas — top geographies include New Jersey, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00741390 about?
NCT00741390 is a clinical study titled "Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose". The procurement of blood for SMBG, usually via a finger stick, is considered by many patients to be the most painful portion of diabetes therapy. This has led to the marketing of smaller gauge lancets, lancing devices with variable depth settings and blood glucose sensors that require less blood for...
What is the current status of trial NCT00741390?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2008-08. Estimated completion is 2008-09.
What conditions does trial NCT00741390 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00741390?
The interventions under investigation include: BD/33G (DEVICE), OTM / 33G (DEVICE), OTU/28G (DEVICE), ACC/28G (DEVICE), OTM/28G (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00741390?
This trial is sponsored by Becton, Dickinson and Company, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00741390 being conducted?
This trial has 4 study locations across Colorado, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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