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

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ClinicalTrials.gov Identifier: NCT00401622
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Collaborators:
Synexus(UK)
CPS(UK)
Battelle CRO(US)
RPS CRO(US)
Robertson Centre For Biostatistics (UK)
Information provided by:
LifeScan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Diabetes Mellitus, Type 2
Interventions Behavioral: OneTouch® Ultra®2 System
Behavioral: Standard care
Enrollment 320
Recruitment Details Recruitment was conducted at 18 study sites at various locations in the UK (6 Sites), US (10 Sites) and Canada (2 Sites). The first subject was enrolled on 10th October 2006 and the last Subject completed the study on 28th December 2008. Participating sites included family practice centres (US and UK) and hospital based clinical sites in the US.
Pre-assignment Details  
Arm/Group Title OneTouch® Ultra®2 System Standard Care
Hide Arm/Group Description Test care group assigned to OneTouch® Ultra®2 System Control group receiving standard care with a traditional blood glucose monitoring system
Period Title: Overall Study
Started 160 160
Completed 126 117
Not Completed 34 43
Arm/Group Title OneTouch® Ultra®2 System Standard Care Total
Hide Arm/Group Description Test care group assigned to OneTouch® Ultra®2 System Control group receiving standard care with a traditional blood glucose monitoring system Total of all reporting groups
Overall Number of Baseline Participants 160 160 320
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 160 participants 320 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
101
  63.1%
101
  63.1%
202
  63.1%
>=65 years
59
  36.9%
59
  36.9%
118
  36.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants 160 participants 320 participants
60.5  (10.97) 61.1  (10.54) 60.8  (10.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 160 participants 320 participants
Female
60
  37.5%
69
  43.1%
129
  40.3%
Male
100
  62.5%
91
  56.9%
191
  59.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 160 participants 160 participants 320 participants
United States 109 103 212
Canada 12 9 21
United Kingdom 39 48 87
Baseline A1C  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 160 participants 160 participants 320 participants
7.6  (0.48) 7.6  (0.49) 7.6  (0.49)
Fasting glucose  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 160 participants 160 participants 320 participants
141.1  (33.40) 144.8  (39.19) 143.0  (36.41)
1.Primary Outcome
Title To Assess the Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
Hide Description [Not Specified]
Time Frame From baseline to 52 wks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups
Arm/Group Title OneTouch® Ultra®2 System Standard Care
Hide Arm/Group Description:
Test care group assigned to OneTouch® Ultra®2 System
Control group receiving standard care with a traditional blood glucose monitoring system
Overall Number of Participants Analyzed 125 116
Least Squares Mean (Standard Error)
Unit of Measure: Percentage
LS Mean -0.35  (0.073) -0.18  (0.076)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OneTouch® Ultra®2 System, Standard Care
Comments Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method ANCOVA
Comments Visit 1 A1c measurement used as the covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.38 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title To Assess the Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Hide Description [Not Specified]
Time Frame 52 wks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OneTouch® Ultra®2 System Standard Care
Hide Arm/Group Description:
Test care group assigned to OneTouch® Ultra®2 System
Control group receiving standard care with a traditional blood glucose monitoring system
Overall Number of Participants Analyzed 115 101
Mean (Standard Deviation)
Unit of Measure: mg/dL
Daily glycemic excursions (Week 52) 102.7  (49.03) 105.8  (38.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OneTouch® Ultra®2 System, Standard Care
Comments Change in Daily Glycemic Excursions from baseline to week 52 between the OneTouch® Ultra®2 and Control BGMS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.56
Confidence Interval (2-Sided) 95%
-7.24 to 22.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.51
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OneTouch® Ultra®2 System Standard Care
Hide Arm/Group Description Test care group assigned to OneTouch® Ultra®2 System Control group receiving standard care with a traditional blood glucose monitoring system
All-Cause Mortality
OneTouch® Ultra®2 System Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
OneTouch® Ultra®2 System Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/160 (0.00%)      1/160 (0.63%)    
Surgical and medical procedures     
Bypass surgery  0/0  0 1/160 (0.63%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OneTouch® Ultra®2 System Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/160 (0.00%)      0/160 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mike Grady
Organization: LifeScan Scotland
Phone: (44) 01463 721889
Responsible Party: Vice President, Worldwide Clinical Affairs, LifeScan, Inc.
ClinicalTrials.gov Identifier: NCT00401622     History of Changes
Other Study ID Numbers: CR-1039797
First Submitted: November 16, 2006
First Posted: November 20, 2006
Results First Submitted: May 29, 2010
Results First Posted: September 16, 2010
Last Update Posted: September 16, 2010