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

Tracking Information

First Received Date ^ICMJE

August 7, 2009

Last Updated Date

June 23, 2011

Start Date ^ICMJE

September 2009

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00956800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

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

Study Arm (s)

Experimental: telemedicine/study group
Intervention: Other: Accu-Chek 360 software
Active Comparator: control group
Intervention: Other: Normal care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00956800

Other Study ID Numbers ^ICMJE

Roche 360

Has Data Monitoring Committee

Responsible Party

Steven B. Leichter, M.D., Columbus Research Foundation

Study Sponsor ^ICMJE

Columbus Research Foundation

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:

Steven B Leichter, M.D.

Endocrine Consultants

Information Provided By

Columbus Research Foundation

Verification Date

June 2011

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

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