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

NCT ID: NCT00956800

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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telemedicine/study group

Group Type EXPERIMENTAL

Accu-Chek 360 software

Intervention Type OTHER

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.

control group

Group Type ACTIVE_COMPARATOR

Normal care

Intervention Type OTHER

Control group will receive 5 routine office visits in one year

Interventions

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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.

Intervention Type OTHER

Normal care

Control group will receive 5 routine office visits in one year

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Columbus Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Columbus Research Foundation

Principal Investigators

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Steven B Leichter, M.D.

Role: PRINCIPAL_INVESTIGATOR

Endocrine Consultants

Locations

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Columbus Research Foundation

Columbus, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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Roche 360

Identifier Type: -

Identifier Source: org_study_id

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