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Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Columbus Research Foundation
ClinicalTrials.gov Identifier:
NCT00956800
First received: August 7, 2009
Last updated: June 23, 2011
Last verified: June 2011

August 7, 2009
June 23, 2011
September 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00956800 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
  • 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.
  • Other: Normal care
    Control group will receive 5 routine office visits in one year
  • Experimental: telemedicine/study group
    Intervention: Other: Accu-Chek 360 software
  • Active Comparator: control group
    Intervention: Other: Normal care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00956800
Roche 360
No
Steven B. Leichter, M.D., Columbus Research Foundation
Columbus Research Foundation
Hoffmann-La Roche
Principal Investigator: Steven B Leichter, M.D. Endocrine Consultants
Columbus Research Foundation
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP