Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
1 other identifier
interventional
100
1 country
1
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 existing guidelines, as providing all care to patients in person.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 27, 2011
June 1, 2011
1.7 years
August 7, 2009
June 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
18 months
Study Arms (2)
telemedicine/study group
EXPERIMENTALcontrol group
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Male and Female
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbus Research Foundationlead
- Hoffmann-La Rochecollaborator
Study Sites (1)
Columbus Research Foundation
Columbus, Georgia, 31904, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven B Leichter, M.D.
Endocrine Consultants
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 7, 2009
First Posted
August 11, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 27, 2011
Record last verified: 2011-06