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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
LifeScan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)
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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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