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

Study Overview
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Other: Accu-Chek 360 software
* Other: Normal care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemedicine/study group<br> | Other: Accu-Chek 360 software<br>* 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.<br>|
| Active Comparator: control group<br> | Other: Normal care<br>* Control group will receive 5 routine office visits in one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |