Study Stopped
participants lost to follow-up;
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.
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
March 12, 2018
CompletedJune 2, 2023
December 1, 2019
1.2 years
February 7, 2011
February 8, 2018
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months
6 months
Study Arms (2)
Control
NO INTERVENTIONProvider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
Intervention
ACTIVE COMPARATORHome 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- Maryland Industrial Partnershipscollaborator
- Telcare, Inccollaborator
Study Sites (1)
University of Maryland
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- *Administrator, Division of Gerontology
- Organization
- University of Maryland Baltimore
Study Officials
- STUDY DIRECTOR
Cindy Geppi
University of Maryland, Baltimore
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2011
First Posted
April 25, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 2, 2023
Results First Posted
March 12, 2018
Record last verified: 2019-12