Smart Glucose Meter Project
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | April 2011 |
| End Date: | June 2012 |
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.
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.
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.
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.
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
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