NCT00401622

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
3 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 16, 2010

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

2.3 years

First QC Date

November 16, 2006

Results QC Date

May 29, 2010

Last Update Submit

May 3, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.

    From baseline to 52 wks

Secondary Outcomes (1)

  • Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.

    52 wks

Study Arms (2)

OneTouch® Ultra®2 system

EXPERIMENTAL

Test care group assigned to OneTouch® Ultra®2 system

Behavioral: OneTouch® Ultra®2 System

Standard care

ACTIVE COMPARATOR

Control group receiving standard care with a traditional blood glucose monitoring system

Behavioral: Standard care

Interventions

OneTouch® Ultra®2 SystemBEHAVIORAL

Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program

OneTouch® Ultra®2 system
Standard careBEHAVIORAL

Standard education and self-monitoring of blood glucose performed with traditional meter systems

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current diagnosis of type 2 diabetes
  • Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
  • Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
  • Baseline HbA1c of 7.0 to 8.9%, inclusive

You may not qualify if:

  • Using insulin
  • Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
  • Known history of anemia or disorders associated with anemia
  • Has previously used the devices being tested in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Phoenix, Arizona, 85018, United States

Location

Unknown Facility

San Diego, California, 92161, United States

Location

Unknown Facility

Wilmington, Delaware, 19805, United States

Location

Unknown Facility

Hollywood, Florida, 33023, United States

Location

Unknown Facility

Dawsonville, Georgia, 30534, United States

Location

Unknown Facility

Whitehouse Station, New Jersey, 08889, United States

Location

Unknown Facility

East Syracuse, New York, 13057, United States

Location

Unknown Facility

Endwell, New York, 13760, United States

Location

Unknown Facility

Syracuse, New York, 13210, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Oshawa, Ontario, L1H1017, Canada

Location

Unknown Facility

Windsor, Ontario, N8W3P6, Canada

Location

Unknown Facility

Reading, Berkshire, RG2 7AG, United Kingdom

Location

Unknown Facility

Llanishen, Cardiff, CF145GJ, United Kingdom

Location

Unknown Facility

Buckshaw Village, Chorley, PR7 7NA, United Kingdom

Location

Unknown Facility

Lloyd Street North, Manchester, M15 6SX, United Kingdom

Location

Unknown Facility

Glasgow, Scotland, G20 0XA, United Kingdom

Location

Unknown Facility

Claygate, Surrey, KT10 OSA, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Mike Grady
Organization
LifeScan Scotland
mgrady@its.jnj.com
(44) 01463 721889

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 20, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 15, 2019

Results First Posted

September 16, 2010

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(6)US(10)CA(2)