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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
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
 Other: Accu-Chek 360 software
Other: Normal care

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Columbus Research Foundation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956800

Locations
United States, Georgia
Columbus Research Foundation
Columbus, Georgia, United States, 31904
Sponsors and Collaborators
Columbus Research Foundation
Hoffmann-La Roche
Investigators
Principal Investigator: Steven B Leichter, M.D. Endocrine Consultants
  More Information

No publications provided

Responsible Party: Steven B. Leichter, M.D., Columbus Research Foundation
ClinicalTrials.gov Identifier: NCT00956800     History of Changes
Other Study ID Numbers: Roche 360
Study First Received: August 7, 2009
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013