NCT01354015

Diabetes Remote Care Management System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Tulane University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective To determine the feasibility of using cell and phone technology to monitor, intervene and manage diabetes in patients using insulin. Secondary Objectives: 1.To determine whether the DRMS system leads to improved glucose control (as measured by HgA1cHbA1c) during participation in the pilot .2.To determine whether the DRMS system leads to improved management and adherence to insulin as well as other diabetic medications .3.To determine whether the DRMS system can be used as a cost effective solution for interventions across a broad segment (both demographic and economic groups) of the diabetes population. This pilot will enroll 100 injectible insulin dependent patients with uncomplicated Type I1 and Type II2 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. It is anticipated that 150 patients will be screened in order to enroll 100 patients in the clinical trial. 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 titration 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

• Diabetes

Interventions

Type	Name	Description
DEVICE	DRMS	USE OF TEXT MESSAGING SYSTEM

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-05-16
• Last updated: 2017-05-09
• Results posted: 2015-01-13

Locations

1 site across 1 country: United States