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

• Sponsor: LifeScan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00401622
• Collaborator: Synexus(UK) (Other), CPS(UK) (Other), Battelle CRO(US) (Other), RPS CRO(US) (Other), Robertson Centre For Biostatistics (UK) (Other)
• Enrollment: 320
• Locations: 18
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site: 17.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: OneTouch® Ultra®2 System; Behavioral: Standard care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Actual Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OneTouch® Ultra®2 system Test care group assigned to OneTouch® Ultra®2 system	Behavioral: OneTouch® Ultra®2 System; Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
Active Comparator: Standard care Control group receiving standard care with a traditional blood glucose monitoring system	Behavioral: Standard care; Standard education and self-monitoring of blood glucose performed with traditional meter systems

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. [52 wks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States	85018
2		San Diego	California	United States	92161
3		Wilmington	Delaware	United States	19805
4		Hollywood	Florida	United States	33023
5		Dawsonville	Georgia	United States	30534
6		Whitehouse Station	New Jersey	United States	08889
7		East Syracuse	New York	United States	13057
8		Endwell	New York	United States	13760
9		Syracuse	New York	United States	13210
10		San Antonio	Texas	United States	78229
11		Oshawa	Ontario	Canada	L1H1017
12		Windsor	Ontario	Canada	N8W3P6
13		Reading	Berkshire	United Kingdom	RG2 7AG
14		Llanishen	Cardiff	United Kingdom	CF145GJ
15		Buckshaw Village	Chorley	United Kingdom	PR7 7NA
16		Lloyd Street North	Manchester	United Kingdom	M15 6SX
17		Glasgow	Scotland	United Kingdom	G20 0XA
18		Claygate	Surrey	United Kingdom	KT10 OSA

Sponsors and Collaborators

• LifeScan
• Synexus(UK)
• CPS(UK)
• Battelle CRO(US)
• RPS CRO(US)
• Robertson Centre For Biostatistics (UK)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LifeScan
• ClinicalTrials.gov Identifier: NCT00401622
• Other Study ID Numbers: CR-1039797
• First Posted: Nov 20, 2006
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

Participant Flow

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.

Arm/Group Title	OneTouch® Ultra®2 System	Standard Care
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

Baseline Characteristics

Arm/Group Title	OneTouch® Ultra®2 System	Standard Care	Total
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 Participants	160	160	320
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.5 (10.97)	61.1 (10.54)	60.8 (10.74)
Sex: Female, Male (Count of Participants)
Female	60 37.5%	69 43.1%	129 40.3%
Male	100 62.5%	91 56.9%	191 59.7%
Region of Enrollment (participants) [Number]
United States	109 68.1%	103 64.4%	212 66.3%
Canada	12 7.5%	9 5.6%	21 6.6%
United Kingdom	39 24.4%	48 30%	87 27.2%
Baseline A1C (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	7.6 (0.48)	7.6 (0.49)	7.6 (0.49)
Fasting glucose (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	141.1 (33.40)	144.8 (39.19)	143.0 (36.41)

Outcome Measures

1. Secondary Outcome

Title	Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Time Frame	52 wks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OneTouch® Ultra®2 System	Standard Care
Arm/Group Description	Test care group assigned to OneTouch® Ultra®2 System	Control group receiving standard care with a traditional blood glucose monitoring system
Measure Participants	115	101
Mean (Standard Deviation) [mg/dL]	102.7 (49.03)	105.8 (38.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OneTouch® Ultra®2 System, Standard Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	t-test, 2 sided
	Comments
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

2. Primary Outcome

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

Outcome Measure Data

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
Arm/Group Description	Test care group assigned to OneTouch® Ultra®2 System	Control group receiving standard care with a traditional blood glucose monitoring system
Measure Participants	125	116
Least Squares Mean (Standard Error) [Percentage]	-0.35 (0.073)	-0.18 (0.076)

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
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	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

Adverse Events

Arm/Group Title	OneTouch® Ultra®2 System		Standard Care
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	OneTouch® Ultra®2 System		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/160 (0%)		1/160 (0.6%)
Vascular disorders
BLOCKED ARTERIES ACROSS GROIN	0/160 (0%)	0	1/160 (0.6%)	1
Other (Not Including Serious) Adverse Events
	OneTouch® Ultra®2 System		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/160 (0%)		0/160 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.