Diabetes Remote Care Management System

NCT01354015 | Completed Results

• 1 other identifier: 1-Fonseca
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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. 1.Monitor and intervene to remind patients to fill their prescriptions
2. 2.Monitor and track insulin unit consumption utilization and timing of that dosage
3. 3.Monitor and intervene when the patient does not use or take their medications as prescribed.
4. 4.Monitor and track insulin unit consumption and timing of that dosage
5. 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. 6.Deliver automated dose adjustment directions based on the providers instructions
7. 7.Coordinate personalized educational programs and messages into the automated intervention programs
8. 8.Provide feedback to the patients, including performance and reinforcement to both providers and to patients.
9. 9.Provide feedback to providers on patients performance as well as exception based reporting

Conditions

Diabetes

Keywords

Diabetes; Technology

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  change in A1c from baseline in intervention and control groups

  baseline to 6 months

Secondary Outcomes (1)

• Change in HbA1c Over 3 Months

  baseline to 3 months

Study Arms (2)

Use of messaging system

EXPERIMENTAL

Use of DRMS

Device: DRMS

Usual Care

NO INTERVENTION

Usual Care

Interventions

DRMS DEVICE

USE OF TEXT MESSAGING SYSTEM

Use of messaging system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr Vivian Fonseca
• Organization: Tulane University

vfonseca@tulane.edu

5049884026

Study Officials

• Vivian Fonseca

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 16, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 9, 2017
• Results First Posted: January 13, 2015

Record last verified: 2017-03

Locations

US (1)