Diabetes Clinical Trial
Official title:
Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
The purpose of this study is to determine if providing some care to diabetic patients remotely, using Accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person.
This will be a non-inferiority study between two groups: a control group, which will receive
5 routine office visits in one year; and a study group which will receive 3 routine office
visits in the same time, and have two visits conducted by computer interaction, using the
Accuchek 360 software. All will be capable of independent care of their diabetes. All
patients will be 19-65 years of age. The end-points will include similar changes in
hemoglobin A1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and
similar levels of patient satisfaction with care.
There will be 50 patients in each group, matched for age and sex distribution, educational
level, computer literacy, and type of diabetes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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