Status:
COMPLETED
Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
Lead Sponsor:
Columbus Research Foundation
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Diabetes
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
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 exist...
Detailed Description
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 sa...
Eligibility Criteria
Inclusion
- Male and Female
- 19-65 years of age
- Type 1 and 2 diabetes
- Computer literate
- Independent care of diabetes
- Insulin pump allowed (Spirit pump only)
- Females on birth control
- Can demonstrate competency in the use of the Accuchek Aviva meter, reliability in doing regular home blood sugar determinations
Exclusion
- Creatinine clearance \< 30 cc/min
- Severe loss of vision (diabetic retinopathy)
- Severe diabetic neuropathy
- Known or suspected diabetic gastroparesis
- Patients with heart disease
- Patients with liver disease
- Drug or substantial alcohol use
- Use of pharmacological doses of glucocorticoids or other medications that affect blood sugar and blood pressure
- Females that are pregnant or are capable of becoming pregnant
- Insulin pump use other than Accucheck Spirit pump
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00956800
Start Date
September 1 2009
End Date
June 1 2011
Last Update
June 27 2011
Active Locations (1)
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1
Columbus Research Foundation
Columbus, Georgia, United States, 31904