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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Accu-Chek 360 software; Other: Normal care

• Registration Number: NCT00956800
• Lead Sponsor: Columbus Research Foundation

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 Timeline

• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2009-09
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telemedicine/study group	Accu-Chek 360 software	-
control group	Normal care	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Columbus Research Foundation; 🇺🇸 Columbus, Georgia, United States