Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OneTouch® Ultra®2 System
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:·
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OneTouch® Ultra®2 system
Standard care
Arm Description
Test care group assigned to OneTouch® Ultra®2 system
Control group receiving standard care with a traditional blood glucose monitoring system
Outcomes
Primary Outcome Measures
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
Secondary Outcome Measures
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Full Information
NCT ID
NCT00401622
First Posted
November 16, 2006
Last Updated
May 3, 2019
Sponsor
LifeScan
Collaborators
Synexus(UK), CPS(UK), Battelle CRO(US), RPS CRO(US), Robertson Centre For Biostatistics (UK)
1. Study Identification
Unique Protocol Identification Number
NCT00401622
Brief Title
Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2006 (Actual)
Primary Completion Date
January 1, 2009 (Actual)
Study Completion Date
January 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeScan
Collaborators
Synexus(UK), CPS(UK), Battelle CRO(US), RPS CRO(US), Robertson Centre For Biostatistics (UK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OneTouch® Ultra®2 system
Arm Type
Experimental
Arm Description
Test care group assigned to OneTouch® Ultra®2 system
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Control group receiving standard care with a traditional blood glucose monitoring system
Intervention Type
Behavioral
Intervention Name(s)
OneTouch® Ultra®2 System
Intervention Description
Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Standard education and self-monitoring of blood glucose performed with traditional meter systems
Primary Outcome Measure Information:
Title
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
Time Frame
From baseline to 52 wks
Secondary Outcome Measure Information:
Title
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Time Frame
52 wks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:·
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
Exclusion Criteria:
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
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
City
Whitehouse Station
State/Province
New Jersey
ZIP/Postal Code
08889
Country
United States
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H1017
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W3P6
Country
Canada
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 7AG
Country
United Kingdom
City
Llanishen
State/Province
Cardiff
ZIP/Postal Code
CF145GJ
Country
United Kingdom
City
Buckshaw Village
State/Province
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
City
Lloyd Street North
State/Province
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G20 0XA
Country
United Kingdom
City
Claygate
State/Province
Surrey
ZIP/Postal Code
KT10 OSA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
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