Smart Glucose Meter Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01341587
Recruitment Status : Terminated (participants lost to follow-up;)
First Posted : April 25, 2011
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Maryland Industrial Partnerships
Telcare, Inc
Information provided by (Responsible Party):
Charlene C. Quinn, University of Maryland

Brief 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.

Condition or disease Intervention/treatment
Type 1 Diabetes Type 2 Diabetes Device: Telcare Blood Glucose Meter (BGM)

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : April 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
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

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 6 months ]
    Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01341587

United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Maryland Industrial Partnerships
Telcare, Inc
Principal Investigator: Charlene Quinn, PhD, RN University of Maryland

Responsible Party: Charlene C. Quinn, Assistant Professor, University of Maryland Identifier: NCT01341587     History of Changes
Other Study ID Numbers: HP-00045527
First Posted: April 25, 2011    Key Record Dates
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018
Last Verified: February 2018

Keywords provided by Charlene C. Quinn, University of Maryland:
SMBG (self monitoring of blood glucose)
mobile technology

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases