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| Sponsor: | University of Maryland |
|---|---|
| Collaborators: |
Maryland Industrial Partnerships Telcare, Inc |
| Information provided by: | University of Maryland |
| ClinicalTrials.gov Identifier: | NCT01341587 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes Type 2 Diabetes |
Device: Telcare Blood Glucose Meter (BGM) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of a Cellular-embedded Glucose Meter With Two-way Personalized Communication Between Patients and Care Managers With a Glucose Meter in Standard Practice in the Care of Diabetic Patients. |
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
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|
Active Comparator: 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. |
Device: Telcare Blood Glucose Meter (BGM)
Cellular enabled glucometer
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tammy Bremer | (410) 706-3467 | Tammy.Bremer@va.gov |
| Contact: Charlene C Quinn, PhD | (410) 7062406 | cquinn@epi.umaryland.edu |
| United States, Maryland | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Principal Investigator: | Charlene Quinn, PhD, RN | University of Maryland |
More Information
| Responsible Party: | Charlene C Quinn, RN, PhD, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT01341587 History of Changes |
| Other Study ID Numbers: | HP-00045527 |
| Study First Received: | February 7, 2011 |
| Last Updated: | April 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
SMBG (self monitoring of blood glucose) diabetes mobile technology |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
