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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956800
• Other study ID #: Roche 360
• Status: Completed
• Phase: N/A
• First received: August 7, 2009
• Last updated: June 23, 2011
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Columbus Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• Normal care
Control group will receive 5 routine office visits in one year

Locations

Country	Name	City	State
United States	Columbus Research Foundation	Columbus	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Columbus Research Foundation	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No