Smart Glucose Meter Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Device: Telcare Blood Glucose Meter (BGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Diagnosis of Diabetes Mellitus (Type 1 or Type 2) Currently, non-compliant with prescribed glucose testing regimen HbA1c of 7.5 or greater within the last six months Exclusion Criteria: Actively being treated for substance abuse Treatment for a thought disorder within the past year Non-English speaking Persons who are legally blind Women who are pregnant Cognitively or decisionally impaired as determined by practitioner Persons using an insulin pump

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) | |
| Active Comparator: Intervention<br>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)<br>* Cellular enabled glucometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMBG (self monitoring of blood glucose), mobile technology, diabetes