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

Columbus Research Foundation

Status: Completed

Conditions: Diabetes

Treatments: Other: Accu-Chek 360 software; Other: Normal care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00956800

Roche 360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

telemedicine/study group

Experimental group

Treatment:

Other: Accu-Chek 360 software

control group

Active Comparator group

Treatment:

Other: Normal care