Diabetes
Conditions
Keywords
type 2 diabetes, nurse case management, telemedicine
Brief summary
The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.
Detailed description
The long-term goal is to develop a practical and sustainable system of diabetes management that will help low income patients achieve and maintain goals within established treatment guidelines regardless of geographic location. This randomized clinical trial will employ the innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management (TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM). The target population will be low income patients served in Federally Qualified Health Care Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care) and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6 months, with study visits at baseline, 3, and 6 months. The primary outcome will be Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be blood pressure control and quality of life (qol) at 6 months post-randomization.
Interventions
BEHAVIORALTechnology-Assisted Case Management
The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse case manager will have access to a secure server to which the uploaded measurements are stored in real time. Medications are titrated under supervision of a primary care and endocrinology physicians
Sponsors
United States Department of Defense
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years and receiving care within the Franklin C. Fetter Family Health Center * Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit * Subject must be willing to use the FORA 2-in-1 system * Subject must have a working land-line for the duration of the study in order to be able to upload the readings from the FORA 2-in-1 machine * Subjects must be able to communicate in English
Exclusion criteria
* Mental confusion on interview suggesting significant dementia * Participation in other diabetes clinical trials * Alcohol or drug abuse/dependency using a screening questionnaire * Active psychosis or acute mental disorder * Life expectancy \<6 months * Pregnant and/or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) at 6 Months Post Randomization | 6 months post randomization | Hemoglobin A1c (HbA1c) was measured at 6 months post randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy. | 59 |
| Technology-assisted Case Management (TACM) This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach.
Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. | 54 |
| Total | 113 |
Baseline characteristics
| Characteristic | Usual Care | Technology-assisted Case Management (TACM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 54 Participants | 113 Participants |
| 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 | 46 Participants | 39 Participants | 85 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 | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Female | 48 Participants | 44 Participants | 92 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 54 |
| other Total, other adverse events | 0 / 59 | 0 / 54 |
| serious Total, serious adverse events | 0 / 59 | 0 / 54 |
Outcome results
Primary
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
Hemoglobin A1c (HbA1c) was measured at 6 months post randomization
Time frame: 6 months post randomization
Population: Final analysis used baseline A1c analysis of covariance for differences in levels of A1c at 6 months between the treatment groups with baseline A1c as covariate.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Hemoglobin A1c (HbA1c) at 6 Months Post Randomization | 10.0 percentage of glycosylated hemoglobin | Standard Deviation 2.7 |
| Technology-assisted Case Management (TACM) | Hemoglobin A1c (HbA1c) at 6 Months Post Randomization | 9.0 percentage of glycosylated hemoglobin | Standard Deviation 1.9 |
p-value: <0.05ANCOVA