CompletedNCT01354015DRMSUpdated May 9, 2017Results posted

Diabetes Remote Care Management System

An interventional study of DRMS in Diabetes, sponsored by Tulane University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Tulane University School of Medicine · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 98
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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:

Monitor and intervene to remind patients to fill their prescriptions
Monitor and track insulin unit consumption utilization and timing of that dosage
Monitor and intervene when the patient does not use or take their medications as prescribed.
Monitor and track insulin unit consumption and timing of that dosage
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
Deliver automated dose adjustment directions based on the providers instructions
Coordinate personalized educational programs and messages into the automated intervention programs
Provide feedback to the patients, including performance and reinforcement to both providers and to patients.
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.

Read the 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:

Monitor and intervene to remind patients to fill their prescriptions
Monitor and track insulin unit consumption utilization and timing of that dosage
Monitor and intervene when the patient does not use or take their medications as prescribed.
Monitor and track insulin unit consumption and timing of that dosage
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
Deliver automated titration directions based on the providers instructions
Coordinate personalized educational programs and messages into the automated intervention programs
Provide feedback to the patients, including performance and reinforcement to both providers and to patients.
Provide feedback to providers on patients performance as well as exception based reporting

Conditions studied

Diabetes

Browse trials for

Diabetes Mellitus 10,925

Keywords

Diabetes
Technology

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 98 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Tulane University School of Medicine is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

18 years of age or older.
Able to read and understand the ICF and provide written consent.
Diagnosis of Type 1 or Type 2 diabetes. If Type 1 diabetes, requirement that they be on insulin and if Type 2 diabetes, requirement that they be on r insulin.
Recent HbA1c blood test (within the last 30 days).
An HbA1c reading of 7.5% - 9.0%.
Patient must own or have access to cell phone on a daily basis throughout the study period, and optionally can have a conventional phone or access to the Internet.
Patient possesses a blood sugar monitor and has access to supplies.
Patient is felt to be able to be compliant with the study.
Patient has no plans to move over the 6 month period of the study.

Exclusion criteria

Exclusion Criteria:

Have active cancer other than basal cell carcinoma or cervical or breast cancer in situ.
In the opinion of the investigator are not suitable for entry into the study.
History of any psychiatric or neurologic condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
Pregnant or breast-feeding females.
History (within last 6 months) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; clinically significant ischemic heart disease; QTcF interval > 450 msec at screening; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea) or uncontrolled cardiac arrhythmias.
History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability.
Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization) that would impair the ability of the patient to participate in the trial.
Hypoglycemia Unawareness
-

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 98 participants (actual)

Study arms

Experimental
Use of messaging system
Use of DRMS
Device: DRMS
No intervention
Usual Care
Usual Care

Interventions

DeviceDRMS
USE OF TEXT MESSAGING SYSTEM

What researchers measure

Primary outcomes

Change in HbA1c
change in A1c from baseline in intervention and control groups
Time frame: baseline to 6 months

Secondary outcomes

Change in HbA1c Over 3 Months
Change in HbA1c
Time frame: baseline to 3 months

Results

Posted Jan 13, 2015

Participant flow

01/01/12 from diabetes clinic

Participant flow — Overall Study
Milestone	Use of Messaging System	Usual Care
Started	50	48
Completed	44	43
Not completed	6	5

Outcome measures

PrimaryChange in HbA1c

change in A1c from baseline in intervention and control groups

Time frame:: baseline to 6 months
Reported as:: Mean · Percent

Change in HbA1c
Percent	Use of Messaging System	Usual Care
Change in HbA1c	-0.25 ± 0.2	-0.4 ± 0.3

Statistical analysis

Use of Messaging System · ANOVA · p = 0.2539 · Mean difference (final values): 0.15

SecondaryChange in HbA1c Over 3 Months

Change in HbA1c

Time frame:: baseline to 3 months
Reported as:: Mean · Percent

Change in HbA1c Over 3 Months
Percent	Use of Messaging System	Usual Care
Change in HbA1c Over 3 Months	-0.5 ± 0.3	-0.2 ± 0.2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Use of Messaging System	—	0/50 (0%)	0/50 (0%)
Usual Care	—	0/48 (0%)	0/48 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Use of Messaging System	Usual Care	Total
Mean	58.9 ± 10.3	59.3 ± 8.7	59.1 ± 9.5

Sex: Female, Male
Sex: Female, Male(Participants)	Use of Messaging System	Usual Care	Total
Female	34	25	59
Male	16	23	39

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Use of Messaging System	Usual Care	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	37	27	64
White	13	17	30
More than one race	0	0	0
Unknown or Not Reported	0	3	3

Study locations

1 site

Tulane University
New Orleans, Louisiana 70112, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01354015
Lead sponsor: Tulane University School of Medicine
Collaborators: Eli Lilly and Company
Responsible party: Vivian Fonseca (Professor, Tulane University School of Medicine) — Principal investigator
First posted: May 16, 2011
Start date: May 2011
Primary completion: Sep 2014
Completion: Sep 2014
Results posted: Jan 13, 2015
Last update: May 9, 2017

Study contacts

Vivian Fonseca

principal investigator · Tulane University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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