NCT00401622 is a NA clinical trial of OneTouch® Ultra®2 System in Diabetes Mellitus, Type 2, sponsored by LifeScan.

Who is sponsoring NCT00401622?

NCT00401622 is sponsored by LifeScan.

What drugs are being tested in NCT00401622?

Interventions in NCT00401622: OneTouch® Ultra®2 System, Standard care.

What condition does NCT00401622 study?

NCT00401622 studies Diabetes Mellitus, Type 2.

Is NCT00401622 still recruiting?

NCT00401622 is currently completed. Last updated 15 May 2019.

Are results published for NCT00401622?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-05-15 · How we verify

NCT00401622

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes

Completed NA Results posted Last updated 15 May 2019

What this trial tests

NA trial testing OneTouch® Ultra®2 System in Diabetes Mellitus, Type 2 in 320 participants. Completed in 1 January 2009.

Timeline

1 October 2006

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	LifeScan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	320
Start date	1 October 2006
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	18 locations across United Kingdom, Canada, United States

Drugs / interventions tested

OneTouch® Ultra®2 System
Standard care — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

LifeScan

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. Secondary · 52 wks

Group	Value	95% CI
OneTouch® Ultra®2 System	102.7	-7.24 – 22.36
Standard Care	105.8	0 – 0

Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. Primary · From baseline to 52 wks

Group	Value	95% CI
OneTouch® Ultra®2 System	-0.35	-0.38 – 0.04
Standard Care	-0.18	0 – 0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OneTouch® Ultra®2 System

Serious: 0/160 (0%)

Deaths: —

Standard Care

Serious: 1/160 (1%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	OneTouch® Ultra®2 System	Standard Care
BLOCKED ARTERIES ACROSS GROIN	Vascular disorders	—	—

Most-reported serious reactions: BLOCKED ARTERIES ACROSS GROIN.

Data from ClinicalTrials.gov NCT00401622 adverse events section.

Sponsor's own description

Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other LifeScan trials

Trials by the same sponsor.

NCT05354297 — Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions · NA · unknown
NCT03556605 — Tu Salud (Your Health) Randomized Control Study in Patients With Diabetes Using a Mobile App. · NA · unknown
NCT03138174 — OneTouch Verio Flex System Accuracy Evaluation · completed
NCT02929654 — Assessment of Blood Glucose Monitoring Devices With New Insight Features · NA · completed
NCT03189225 — Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00401622 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LifeScan
Last refreshed: 15 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00401622.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing