Study Results
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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COMPLETED
NA
300 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DM-Standard
The conventional disease management group will receive management under the site's usual program offering, which includes, but is not limited to, compliance with the prescribed treatment regimens, dietary management, exercise programs, and other measures recommended by the American Diabetes Association (ADA) and the Association of American Endocrinologists (AACE).
DM-Standard
Device/t+ Medical Diabetes Management System
DM-Plus
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology that includes mobile phone client software with web-based companion software, Bluetooth glucose meter cradle, and web-based clinical management software for the clinical management team. The core of the system is the patient's cell phone which is used as an input device and which enables patients to maintain an electronic diary of information such as meal times, blood glucose, insulin use, weight, blood pressure, and exercise. The device is customizable to collect only the information relevant to the patient with diabetes and their healthcare provider. The patient with diabetes enters diary information on his or her mobile phone. No immediate or real-time information is provided to patients as part of this study.
Disease Management Plus
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.
Interventions
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DM-Standard
Device/t+ Medical Diabetes Management System
Disease Management Plus
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period)
* Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days
* Able to provide written informed consent for study participation
Exclusion Criteria
* Selected cancers (one or more claims in the most recent 12-month period)
* HIV/AIDS (one or more claims in the most recent 12-month period)
* Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period)
* Cirrhosis of the liver (one or more claims in the most recent 12-month period)
* Current participation in another LifeScan study or other diabetes-related clinical trials
* Medicare is primary source of insurance coverage
* Unable to understand written and spoken English
18 Years
64 Years
ALL
No
Sponsors
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LifeScan
INDUSTRY
Responsible Party
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SymCare Personalized Health Solutions, Inc.
Principal Investigators
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Donald Fetterolf, MD
Role: PRINCIPAL_INVESTIGATOR
Matria Healthcare
Locations
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Marietta, Georgia, United States
Countries
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Other Identifiers
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7021
Identifier Type: -
Identifier Source: org_study_id