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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|Experimental: telemedicine/study group||
Other: Accu-Chek 360 software
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.
|Active Comparator: control group||
Other: Normal care
Control group will receive 5 routine office visits in one year
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.
|United States, Georgia|
|Columbus Research Foundation|
|Columbus, Georgia, United States, 31904|
|Principal Investigator:||Steven B Leichter, M.D.||Endocrine Consultants|