Smart Glucose Meter Project

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01341587
• Other study ID #: HP-00045527
• Status: Terminated
• Phase: N/A
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• Telcare Blood Glucose Meter (BGM)
Cellular enabled glucometer

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Maryland Industrial Partnerships, Telcare, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months	6 months