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participants lost to follow-up;
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| Name | Class |
|---|---|
| Maryland Industrial Partnerships | OTHER |
| Telcare, Inc | INDUSTRY |
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Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to develop diabetes during his or her lifetime. Research has demonstrated that control of blood glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The value of this approach is known to be limited by a high rate of patient non-compliance with BG testing, where patients test less often than prescribed. Increased communication between patient and care manager along with feedback has been shown to increase self monitoring of blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the current, episodic model of patient / care manager interaction and not available in existing BG meters given to diabetic patients.
In this study, we propose to pilot test a cellular-embedded glucose meter. This device can transmit glucose readings directly over a cellular network to a care management server and then the patient will receive feedback on the screen of the glucose meter.
This research program will enroll participants in a 6-month pilot intervention study. In this study, 100 patients with diabetes (Type 1 and Type 2) who are known to be non-compliant with SMBG will be enrolled and randomized to treatment groups (one group will receive a standard glucose meter and the second group will receive the cellular-embedded device) in order to achieve the following specific study aims;
Primary Aim 1: Determine if connecting diabetic patients to care managers via a cellular-enabled glucose meter with feedback will improve SMBG testing compliance.
Secondary Aim 2: Determine if increased testing compliance leads to improvement in overall blood glucose control. This will be measured by a reduction of HbA1c levels.
Secondary Aim 3: Determine whether this intervention leads to significant improvements in patient satisfaction with self-care and patient self-assessment of compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) | |
| Intervention | Active Comparator | Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback. Care provider can access raw and analyzed patient data; Physician receives report summary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telcare Blood Glucose Meter (BGM) | Device | Cellular enabled glucometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy Geppi | University of Maryland, Baltimore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
| FG001 | Intervention | Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback. Care provider can access raw and analyzed patient data; Physician receives report summary. Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
| BG001 | Intervention | Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback. Care provider can access raw and analyzed patient data; Physician receives report summary. Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer |
| 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 | Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months | Results for change were not collected because the study was stopped. Participants were lost to follow-up and stopped using the meters | Posted | 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 | Control | Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| *Administrator, Division of Gerontology | University of Maryland Baltimore | 4107062406 | cquinn@som.umaryland.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| 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 (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Intervention | Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback. Care provider can access raw and analyzed patient data; Physician receives report summary. Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer | 0 | 10 | 0 | 10 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |