Trial Outcomes & Findings for Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes (NCT NCT00401622)

NCT ID: NCT00401622

Last Updated: 2019-05-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 320 participants
• Primary outcome timeframe: From baseline to 52 wks
• Results posted on: 2019-05-15

Participant Flow

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.

Participant milestones

Measure	OneTouch® Ultra®2 System Test care group assigned to OneTouch® Ultra®2 System	Standard Care Control group receiving standard care with a traditional blood glucose monitoring system
Overall Study STARTED	160	160
Overall Study COMPLETED	126	117
Overall Study NOT COMPLETED	34	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	OneTouch® Ultra®2 System n=160 Participants Test care group assigned to OneTouch® Ultra®2 System	Standard Care n=160 Participants Control group receiving standard care with a traditional blood glucose monitoring system	Total n=320 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants	101 Participants n=7 Participants	202 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants	59 Participants n=7 Participants	118 Participants n=5 Participants
Age, Continuous	60.5 years STANDARD_DEVIATION 10.97 • n=5 Participants	61.1 years STANDARD_DEVIATION 10.54 • n=7 Participants	60.8 years STANDARD_DEVIATION 10.74 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	69 Participants n=7 Participants	129 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	91 Participants n=7 Participants	191 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	103 participants n=7 Participants	212 participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment United Kingdom	39 participants n=5 Participants	48 participants n=7 Participants	87 participants n=5 Participants
Baseline A1C	7.6 Percentage STANDARD_DEVIATION 0.48 • n=5 Participants	7.6 Percentage STANDARD_DEVIATION 0.49 • n=7 Participants	7.6 Percentage STANDARD_DEVIATION 0.49 • n=5 Participants
Fasting glucose	141.1 mg/dl STANDARD_DEVIATION 33.40 • n=5 Participants	144.8 mg/dl STANDARD_DEVIATION 39.19 • n=7 Participants	143.0 mg/dl STANDARD_DEVIATION 36.41 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 52 wks

Population: The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups

Outcome measures

Measure	OneTouch® Ultra®2 System n=125 Participants Test care group assigned to OneTouch® Ultra®2 System	Standard Care n=116 Participants Control group receiving standard care with a traditional blood glucose monitoring system
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.	-0.35 Percentage Standard Error 0.073 • Interval -0.38 to 0.04	-0.18 Percentage Standard Error 0.076 • Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 52 wks

Outcome measures

Measure	OneTouch® Ultra®2 System n=115 Participants Test care group assigned to OneTouch® Ultra®2 System	Standard Care n=101 Participants Control group receiving standard care with a traditional blood glucose monitoring system
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.	102.7 mg/dL Standard Deviation 49.03 • Interval -7.24 to 22.36	105.8 mg/dL Standard Deviation 38.17 • Interval 0.0 to 0.0

Adverse Events

OneTouch® Ultra®2 System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	OneTouch® Ultra®2 System n=160 participants at risk Test care group assigned to OneTouch® Ultra®2 System	Standard Care n=160 participants at risk Control group receiving standard care with a traditional blood glucose monitoring system
Vascular disorders BLOCKED ARTERIES ACROSS GROIN	0.00% 0/160	0.62% 1/160 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Mike Grady

LifeScan Scotland

Phone: (44) 01463 721889

Email: mgrady@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60