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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of messaging system | Experimental | Use of DRMS |
|
| Usual Care | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRMS | Device | USE OF TEXT MESSAGING SYSTEM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | change in A1c from baseline in intervention and control groups | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Over 3 Months | Change in HbA1c | baseline to 3 months |
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Inclusion 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
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| Name | Affiliation | Role |
|---|---|---|
| Vivian Fonseca | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University | New Orleans | Louisiana | 70112 | United States |
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01/01/12 from diabetes clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Use of Messaging System | Use of DRMS DRMS: USE OF TEXT MESSAGING SYSTEM |
| FG001 | Usual Care | Usual Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Use of Messaging System | Use of DRMS DRMS: USE OF TEXT MESSAGING SYSTEM |
| BG001 | Usual Care | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c | change in A1c from baseline in intervention and control groups | Of the 50 enrolled in the Use of DRMS group, only 44 completed the visit at 6 months, and out of 48 enrolled in the Usual Care group only 43 completed the visit at 6 months. Therefore only those who completed the visit at 6 months were included in this analysis. | Posted | Mean | Standard Deviation | Percent | baseline to 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Use of Messaging System | Use of DRMS DRMS: USE OF TEXT MESSAGING SYSTEM |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vivian Fonseca | Tulane University | 5049884026 | vfonseca@tulane.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | self reported | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in HbA1c Over 3 Months | Change in HbA1c | Of the 50 enrolled in the Use of DRMS group, only 46 completed the visit at 3 months, and out of 48 enrolled in the Usual Care group only 45 completed the visit at 3 months. Therefore only those who completed the visit at 3 months were included in this analysis. | Posted | Mean | Standard Deviation | Percent | baseline to 3 months |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Usual Care | Usual Care | 0 | 48 | 0 | 48 |
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