Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)

NCT ID: NCT02194608

Last Updated: 2015-06-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-07-31

Brief Summary

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The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM), as compared to usual practice.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

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.

Group Type EXPERIMENTAL

Home telehealth system

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* has type 2 diabetes
* 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 non-pharmacologically treated
* 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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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.

Reference Type DERIVED
PMID: 26154338 (View on PubMed)

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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