Diabetes Remote Care Management System (DRMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Tulane University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Vivian Fonseca, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT01354015
First received: May 6, 2011
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Diabetes
Device: DRMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diabetes Remote Care Management System

Resource links provided by NLM:


Further study details as provided by Tulane University School of Medicine:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change in A1c from baseline in intervention and control groups


Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Use of messaging system
Use of DRMS
Device: DRMS
USE OF TEXT MESSAGING SYSTEM
No Intervention: Usual Care
Usual Care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older.
  2. Able to read and understand the ICF and provide written consent.
  3. 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.
  4. Recent HbA1c blood test (within the last 30 days).
  5. An HbA1c reading of 7.5% - 9.0%.
  6. 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.
  7. Patient possesses a blood sugar monitor and has access to supplies.
  8. Patient is felt to be able to be compliant with the study.
  9. Patient has no plans to move over the 6 month period of the study.

Exclusion Criteria:

  1. Have active cancer other than basal cell carcinoma or cervical or breast cancer in situ.
  2. In the opinion of the investigator are not suitable for entry into the study.
  3. 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
  4. Pregnant or breast-feeding females.
  5. 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.
  6. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability.
  7. 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.
  8. Hypoglycemia Unawareness

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354015

Contacts
Contact: Vivian Fonseca 504 988 4026 vfonseca@tulane.edu
Contact: Vivian Fonseca vfonseca@tulane.edu

Locations
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Vivian USA Fonseca, USA       vfonseca@tulane.edu   
Contact: Vivian USA Fonseca, MD       vfonseca@tulane.edu   
Principal Investigator: Vivian Fonseca         
Sponsors and Collaborators
Tulane University School of Medicine
Eli Lilly and Company
Investigators
Principal Investigator: Vivian Fonseca Tulane University
  More Information

No publications provided

Responsible Party: Vivian Fonseca, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT01354015     History of Changes
Other Study ID Numbers: 1-Fonseca
Study First Received: May 6, 2011
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tulane University School of Medicine:
Diabetes
Technology

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014