Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes
NCT ID: NCT01715649
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2012-11-30
2014-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control-usual care
Nurse care coordination in a telephonic diabetes disease management program
No interventions assigned to this group
Intervention paired testing and remote monitoring
Telehealth remote patient monitoring, structured blood glucose and usual care Paired testing-weekly remote monitoring Data analysis Virtual visits in EHR
Patient 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.
Interventions
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Patient 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
70 Years
ALL
No
Sponsors
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LifeScan
INDUSTRY
GE Healthcare
INDUSTRY
University of California, Davis
OTHER
Sutter Health
OTHER
Responsible Party
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Deborah Greenwood
Diabetes Clinical Nurse Specialist
Locations
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Sutter Health
Sacramento, California, United States
Countries
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References
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Greenwood DA, Blozis SA, Young HM, Nesbitt TS, Quinn CC. Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes. J Med Internet Res. 2015 Jul 21;17(7):e178. doi: 10.2196/jmir.4112.
Other Identifiers
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1208042ex
Identifier Type: -
Identifier Source: org_study_id