Trial Outcomes & Findings for Smart Glucose Meter Project (NCT NCT01341587)
NCT ID: NCT01341587
Last Updated: 2023-06-02
Results Overview
Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-02
Participant Flow
Participant milestones
| Measure |
Control
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
|
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.
Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
Reasons for withdrawal
| Measure |
Control
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
|
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.
Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
stopped using the meters
|
2
|
10
|
Baseline Characteristics
Smart Glucose Meter Project
Baseline characteristics by cohort
| Measure |
Control
n=4 Participants
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
|
Intervention
n=10 Participants
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.
Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 18 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Results for change were not collected because the study was stopped. Participants were lost to follow-up and stopped using the meters
Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
*Administrator, Division of Gerontology
University of Maryland Baltimore
Phone: 4107062406
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place