CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 98 enrolled
Drug / intervention
DRMSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01354015
NCT01354015N/ACompleted

Diabetes Remote Care Management System

Tulane University School of Medicine·interventional·Posted May 16, 2011·Updated May 9, 2017

In Brief

A clinical study evaluating DRMS for Diabetes. Completed, enrolled 98 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2011
Enrollment StartMay 1, 2011
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.1 years ago

Interventions

DRMSdevice

USE OF TEXT MESSAGING SYSTEM