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Sponsored by: |
LifeScan |
Information provided by: | LifeScan |
ClinicalTrials.gov Identifier: | NCT00675311 |
The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.
Condition | Intervention |
Type 1 Diabetes Type 2 Diabetes |
Behavioral: DM-Standard Behavioral: Disease Management Plus |
MedlinePlus related topics: | Diabetes Diabetes Type 1 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Randomized Study of the Clinical and Economic Impact of Remote Monitoring Program With Disease Management Compared to Conventional Diabetes Disease Management Interventions |
Estimated Enrollment: | 300 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
DM-Standard: Active Comparator
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).
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Behavioral: DM-Standard
Device/t+ Medical Diabetes Management System
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DM-Plus: Active Comparator
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.
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Behavioral: 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.
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To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Arizona | |||||
Scottsdale, Arizona, United States |
LifeScan |
Principal Investigator: | Donald Fetterolf, MD | Matria Healthcare |
Principal Investigator: | Martin Block, MD | SHPS |
Responsible Party: | SymCare Personalized Health Solutions, Inc., a wholly owned subsidiary of LifeScan, Inc. ( Cheryl Pegus, M.D. ) |
Study ID Numbers: | 7021 |
First Received: | May 7, 2008 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00675311 |
Health Authority: | United States: Institutional Review Board |
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