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Smart Glucose Meter Project

This study has been completed.
Sponsor:
Collaborators:
Maryland Industrial Partnerships
Telcare, Inc
Information provided by (Responsible Party):
Charlene C. Quinn, RN, PhD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01341587
First received: February 7, 2011
Last updated: December 10, 2013
Last verified: December 2013

February 7, 2011
December 10, 2013
April 2011
June 2012   (final data collection date for primary outcome measure)
Rate of compliance to glucose monitoring schedule [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Determine if connecting diabetic patients to care managers via a cellular-enabled glucose meter with feedback will improve SMBG testing compliance.
Same as current
Complete list of historical versions of study NCT01341587 on ClinicalTrials.gov Archive Site
  • Improvement of overall blood glucose control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine if increased testing compliance leads to improvement in overall blood glucose control. This will be measured by a reduction of HbA1c levels.
  • Improvement in Patient Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine whether this intervention leads to significant improvements in patient satisfaction with self-care and patient self-assessment of compliance. This will be measured by the Diabetes Treatment Satisfaction Questionnaire by Bradley.
Same as current
Not Provided
Not Provided
 
Smart Glucose Meter Project
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Type 2 Diabetes
Device: Telcare Blood Glucose Meter (BGM)
Cellular enabled glucometer
  • 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.

    Intervention: Device: Telcare Blood Glucose Meter (BGM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01341587
HP-00045527
Yes
Charlene C. Quinn, RN, PhD, University of Maryland
University of Maryland
  • Maryland Industrial Partnerships
  • Telcare, Inc
Principal Investigator: Charlene Quinn, PhD, RN University of Maryland
University of Maryland
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP