Diabetes Mellitus, Type 2
Conditions
Brief summary
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.
Interventions
BEHAVIORALOneTouch® 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
BEHAVIORALStandard care
Standard education and self-monitoring of blood glucose performed with traditional meter systems
Sponsors
Synexus(UK)
CPS(UK)
Battelle CRO(US)
RPS CRO(US)
Robertson Centre For Biostatistics (UK)
LifeScan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. | From baseline to 52 wks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. | 52 wks |
Countries
Canada, United Kingdom, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| OneTouch® Ultra®2 System Test care group assigned to OneTouch® Ultra®2 System | 160 |
| Standard Care Control group receiving standard care with a traditional blood glucose monitoring system | 160 |
| Total | 320 |
Baseline characteristics
| Characteristic | OneTouch® Ultra®2 System | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 59 Participants | 59 Participants | 118 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants | 101 Participants | 202 Participants |
| Age, Continuous | 60.5 years STANDARD_DEVIATION 10.97 | 61.1 years STANDARD_DEVIATION 10.54 | 60.8 years STANDARD_DEVIATION 10.74 |
| Baseline A1C | 7.6 Percentage STANDARD_DEVIATION 0.48 | 7.6 Percentage STANDARD_DEVIATION 0.49 | 7.6 Percentage STANDARD_DEVIATION 0.49 |
| Fasting glucose | 141.1 mg/dl STANDARD_DEVIATION 33.4 | 144.8 mg/dl STANDARD_DEVIATION 39.19 | 143.0 mg/dl STANDARD_DEVIATION 36.41 |
| Region of Enrollment Canada | 12 participants | 9 participants | 21 participants |
| Region of Enrollment United Kingdom | 39 participants | 48 participants | 87 participants |
| Region of Enrollment United States | 109 participants | 103 participants | 212 participants |
| Sex: Female, Male Female | 60 Participants | 69 Participants | 129 Participants |
| Sex: Female, Male Male | 100 Participants | 91 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 160 | 0 / 160 |
| serious Total, serious adverse events | 0 / 160 | 1 / 160 |
Outcome results
Primary
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OneTouch® Ultra®2 System | Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. | -0.35 Percentage | Standard Error 0.073 |
| Standard Care | Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. | -0.18 Percentage | Standard Error 0.076 |
Comparison: Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMSp-value: 0.4595% CI: [-0.38, 0.04]ANCOVA
Secondary
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Time frame: 52 wks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OneTouch® Ultra®2 System | Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. | 102.7 mg/dL | Standard Deviation 49.03 |
| Standard Care | Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. | 105.8 mg/dL | Standard Deviation 38.17 |
p-value: 0.3195% CI: [-7.24, 22.36]t-test, 2 sided