Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
SMBG (self monitoring of blood glucose), diabetes, mobile technology
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.
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.
Interventions
DEVICETelcare Blood Glucose Meter (BGM)
Cellular enabled glucometer
Sponsors
Maryland Industrial Partnerships
Telcare, Inc
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 6 months | Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) | 4 |
| 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 | 10 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | stopped using the meters | 2 | 10 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 18 | 52.3 years STANDARD_DEVIATION 14.1 | 52.8 years STANDARD_DEVIATION 13.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 4 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 10 |
| serious Total, serious adverse events | 0 / 4 | 0 / 10 |
Outcome results
Primary
Change in HbA1c
Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months
Time frame: 6 months
Population: Results for change were not collected because the study was stopped. Participants were lost to follow-up and stopped using the meters