DiabetesDRMSNCT01354015
Diabetes Remote Care Management System
A study testing DRMS in people with Diabetes, run by Tulane University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- DRMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
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
- Being tested
- DRMS
- Keywords
- Diabetes, Technology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRMSDevice
USE OF TEXT MESSAGING SYSTEM
| Study group | Role | What they receive |
|---|---|---|
| Use of messaging system | Experimental | Use of DRMS Receives: Device: DRMS |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
change in A1c from baseline in intervention and control groups
Measured: baseline to 6 months
Secondary outcomes (1)
Change in HbA1c Over 3 Months
Change in HbA1c
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Vivian Fonseca, Tulane University School of Medicine
- Investigators
- Vivian Fonseca, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354015
- Sponsor's protocol ID
- 1-Fonseca
- Acronym
- DRMS
- Status last verified
- Mar 2017
- First submitted
- 6 May 2011
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Remote Care Management System
- ClinicalTrials.gov ID
- NCT01354015
- Acronym / sponsor ID
- DRMS / 1-Fonseca
- Conditions
- Diabetes
- Keywords
- Diabetes, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Tulane University School of MedicineUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Posted 13 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of messaging system | Experimental | Device: DRMSUse of DRMS |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRMSUSE OF TEXT MESSAGING SYSTEM | Device | Use of messaging system |
Primary outcome
Change in HbA1c
Time frame: baseline to 6 months
change in A1c from baseline in intervention and control groups
1 secondary outcome
Change in HbA1c Over 3 Months
Time frame: baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian Fonseca principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DRMS in people with Diabetes, run by Tulane University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017; AzTrials last refreshed its copy on 30 Oct 2026.