Evaluation of a Diabetes Data Management System

NCT ID: NCT00694070

Last Updated: 2016-02-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to evaluate a diabetes data management program in the hands of potential users, both health care professionals and lay users.

Detailed Description

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Diabetes data management programs analyze blood glucose results downloaded from glucose meters to assist health care professionals or lay users manage their diabetes. During the study, subjects download meters, generate and print reports, evaluate the program's ease of use, and verify that they understand the program output.

Conditions

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Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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health care professionals and lay users

h= 8 health care professionals p= 43 lay users

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Health Care Professionals:

1. Must have experience using diabetes data management software in the medical office such as downloading meters, reviewing reports (computer screen or printouts), or assisting in patients' diabetes disease management using software.
2. May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.
* Lay users must:

1. Be at least 18 years of age.
2. Have diabetes (or be the parent or legal guardian of a child with diabetes) and have been testing blood sugar at home at least twice daily for one month or more.
3. Be able to speak, read and understand English.
4. Currently using diabetes management software at home or be familiar with diabetes management software. At least 75% of subjects must have been using software for at least one month.
5. Have experience using PC programs or browsing the internet.

Exclusion Criteria

* Persons working for a competitive medical device company.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascensia Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Locations

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AMCR Institute

Escondido, California, United States

Site Status

Countries

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United States

Other Identifiers

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CTD-2008-11

Identifier Type: -

Identifier Source: org_study_id

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