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Completed

NCT Number: NCT00956800

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbus Research Foundation

Columbus, Georgia, 31904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accu-Chek 360 software

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.

Normal Care

Other

Control group will receive 5 routine office visits in one year

Primary outcomes

  1. 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.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Columbus Research Foundation

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2009
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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