An interventional study of Accu-Chek 360 software and Normal care in Diabetes, sponsored by Columbus Research Foundation. Completed at 1 site in United States. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-27.
Sponsored by Columbus Research Foundation · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Columbus Research Foundation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Accu-Chek 360 software
Other: Normal care
Study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accu-Chek 360 software.
Control group will receive 5 routine office visits in one year
Columbus Research Foundation will take the objective data that constitutes the defined end-points of the study and enter it for each patient into an Access data base, using the established data base management system of Columbus Research Foundation.
Time frame: 18 months
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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