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Diabetes Remote Care Management System

NCT01354015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-05-09

Study results available
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Summary

DRMS is a system that communicates with patients via text message using cellphones, computers and other devices. It reminds patients about multiple health care and disease related issues such as to test their blood sugars and send the result back to the system via text message. The system will then decided based on automated algorithms whether to send another message advising patients on changing their medication etc.

This pilot will enroll 100 injectible insulin dependent patients with uncomplicated Type 1 and Type 2 diabetes mellitus, using insulin, who will be enrolled to participate in the pilot. Patients will be randomized 1:1 to either DRMS or standard care. The patients in the DRMS program will undergo interactions with the system using multiple communications channels including cell phones, IVR, email, web and SMS messaging. The goals of the interactive programs are the following:

1. Monitor and intervene to remind patients to fill their prescriptions
2. Monitor and track insulin unit consumption utilization and timing of that dosage
3. Monitor and intervene when the patient does not use or take their medications as prescribed.
4. Monitor and track insulin unit consumption and timing of that dosage
5. Ask the patient for their glucose levels and then provide customized information to the patients regarding how to modify their medication to achieve the desired glucose level
6. Deliver automated dose adjustment directions based on the providers instructions
7. Coordinate personalized educational programs and messages into the automated intervention programs
8. Provide feedback to the patients, including performance and reinforcement to both providers and to patients.
9. Provide feedback to providers on patients performance as well as exception based reporting

The System will manage interventions in an automated fashion. Providers will intervene on an exception basis and only when automated interventions have not worked or the protocol requires immediate action by the provider. For example, if the glucose exceeds certain danger levels, as defined by the provider, a requirement might be to call and notify the doctor immediately.

Conditions

Interventions

DEVICE

DRMS

USE OF TEXT MESSAGING SYSTEM

Sponsors & Collaborators

Principal Investigators

  • Vivian Fonseca · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354015 on ClinicalTrials.gov