Diabetes
Conditions
Brief summary
Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. Effective presentation and data analysis are essential. We examined HbA1c changes using the OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).
Interventions
DEVICEOneTouch(r) UltraSmart(r)
Sponsors
LifeScan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female subjects with type 1 or type 2 insulin-treated diabetes mellitus with a baseline HbA1c greater than or equal to 8.0%. * The lower age limit for pediatric subjects was at the discretion of the pediatric investigators and their Institutional Review Board (IRBs). * The upper age limit for pediatric subjects was 20 years (i.e., not having reached their 21st birthday on date of enrollment). * Subjects must have monitored blood glucose at least 2 times per day. - Subject's current blood glucose meter has download capability, however, the subject did not routinely use this capability on his/her own.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured hypoglycemia | — |
Countries
United States
Outcome results
None listed