Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01341587
Status:
TERMINATED
Last Update Posted:
2023-06-02
First Post:
2011-02-07
Brief Title:
Smart Glucose Meter Project
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
participants lost to follow-up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently in the US 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
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None