Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)
NCT ID: NCT02194608
Last Updated: 2015-06-24
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
500 participants
INTERVENTIONAL
2011-12-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Telemedicine system
Participants will self-test blood glucose level, weight, and blood pressure and results will be uploaded and transmitted directly via a hometelehealth system to a central location (HUB). Blood draws will be administered at baseline and follow-up visits.
Home telehealth system
Participants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB.
Usual care
Participants will self-record their blood glucose levels, blood pressure and weight in a diary. Blood draws will be administered at baseline and follow-up visits.
No interventions assigned to this group
Interventions
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Home telehealth system
Participants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB.
Eligibility Criteria
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Inclusion Criteria
* treated with oral agents in monotherapy or combined therapy ± basal insulin
* previously educated to self-monitoring blood glucose (SMBG) use
Exclusion Criteria
* has type 2 diabetes treated with multiple daily injections of insulin
* is unable to use the telemedicine system
* pregnancy
* has major cardiovascular, cerebrovascular, or peripheral vascular event in the last 6 months
* has any disease or condition, including alcohol or drugs abuse, that may interfere with study completion
45 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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References
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Nicolucci A, Cercone S, Chiriatti A, Muscas F, Gensini G. A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes. Diabetes Technol Ther. 2015 Aug;17(8):563-70. doi: 10.1089/dia.2014.0355. Epub 2015 Jul 8.
Other Identifiers
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LCE#40378
Identifier Type: OTHER
Identifier Source: secondary_id
0000-347
Identifier Type: -
Identifier Source: org_study_id
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