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NCT01354015 · ClinicalTrials.gov registry record · NA

Diabetes Remote Care Management System

A NA study, sponsored by Tulane University School of Medicine.

Completed
Registry status
NA
Development phase
98
Enrollment target

NCT01354015: Completed NA study, sponsored by Tulane University School of Medicine.

NCT01354015 is a NA study that has completed, run by Tulane University School of Medicine. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01354015, a NA study, has completed, sponsored by Tulane University School of Medicine.

COMPLETED
Registry status
NA
Development phase
98 participants
Enrollment target

Study 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 act

Primary Outcome

change in A1c from baseline in intervention and control groups

Interventions

  • DEVICE DRMS

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2011-05
Est. Completion 2014-09
Phase NA

What the finished NCT01354015 record still lists

NCT01354015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which DRMS is the first listed.

NCT01354015 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01354015 about?

NCT01354015 is a clinical study titled "Diabetes Remote Care Management System". 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 ...

What is the current status of trial NCT01354015?

This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2011-05. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01354015?

The interventions under investigation include: DRMS (DEVICE).

Who is sponsoring clinical trial NCT01354015?

This trial is sponsored by Tulane University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01354015's enrollment target sits among peer trials

98 922nd of 2000 higher than 1,078 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01354015, the US trial registry maintained by the National Library of Medicine. NCT01354015 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.