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
  Purpose

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 Intervention
Type 1 Diabetes
Type 2 Diabetes
Device: Telcare Blood Glucose Meter (BGM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341587

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

No publications provided

Responsible Party: Charlene C. Quinn, RN, PhD, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01341587     History of Changes
Other Study ID Numbers: HP-00045527
Study First Received: February 7, 2011
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
SMBG (self monitoring of blood glucose)
diabetes
mobile technology

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 15, 2014