Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, self-management, remote patient monitoring
Brief summary
Telehealth remote patient monitoring is a means of using communications technology - such as telephones, computers, and the Internet - to connect patients remotely with their healthcare team from their homes. The investigators hope to learn more about improving healthy behaviors and blood glucose among persons with diabetes using telehealth remote patient monitoring technology to connect directly with nurse care coordinators. The purpose of this study is to evaluate a process for improving blood glucose and healthy behaviors among people with type 2 diabetes using telehealth remote patient monitoring technology with nurse care coordinators. Some of the people in this study will work with a nurse care coordinator who will review your blood glucose weekly and call you at home every month for 3 months, while some of the people in this study will simply receive their normal care. At the end of the study, every participant will be asked questions about how they feel about their health care.
Interventions
BEHAVIORALPatient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose
In the intervention arm you will test your blood glucose 2 times a day (before and after a meal, activity or other event) using the glucose meter provided to you for use in this study and connect it to the Telehealth Unit. Every week the study team will review your blood glucose levels through the remote patient monitoring secure portal and send you a reminder through the Telehealth Unit with suggestions based on your blood glucose patterns. Once every month a study nurse will call you to review your blood glucose goals and discuss how you may be able to make changes in your health behaviors to improve your blood glucose levels. The study team will work with you to help you make changes to your behaviors that may improve your blood glucose.
Sponsors
LifeScan
GE Healthcare
University of California, Davis
Sutter Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Enrolled in diabetes disease management program * ages 30-70 * HbA1c between 7.5% and 10.9% in the previous six months * an Internet or 3G connection and email address; * a working phone line (land line or cellular); and * ability to read and understand the English language.
Exclusion criteria
* taking insulin; * inability to independently engage in self-management behaviors (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment); * severe complications, which would preclude achieving an HbA1c goal of 7% including diagnosis of the following: * severe stroke; * heart failure; * end-stage renal disease; * kidney dialysis; and * legally blind.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | Change from baseline to 6 months | Lab test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Empowerment | Change from baseline to 3 months | Diabetes Empowerment Scale completed by survey |
| Behavior Change | Change from baseline to 3 months | Summary of Diabetes Self-Care Behaviors scale completed by survey |
| Knowledge | Change from baseline to 3 months | Michigan Diabetes Knowledge Test completed by survey |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of incorporating the intervention into the existing program | 3 months | Will include # of participants that complete intervention, #of nurse hours required to analyze data and interact with participant,and number of technology issues impacting use |
| Participant engagement with telehealth technology | 3 months | \# of participants that complete the 12 week program, # of participants that upload the blood glucose meter values to the technology |
Countries
United States
Outcome results
None listed