Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Telehealth Intervention Combining Structured Self-Monitoring of Blood Glucose and Nurse Care Coordination Among People With Type 2 Diabetes Noninsulin-Treated

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control-usual care<br>Nurse care coordination in a telephonic diabetes disease management program | |
| Experimental: Intervention paired testing and remote monitoring<br>Telehealth remote patient monitoring, structured blood glucose and usual care Paired testing-weekly remote monitoring Data analysis Virtual visits in EHR | Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Lab test | Change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empowerment | Diabetes Empowerment Scale completed by survey | Change from baseline to 3 months | 
| Behavior Change | Summary of Diabetes Self-Care Behaviors scale completed by survey | Change from baseline to 3 months | 
| Knowledge | Michigan Diabetes Knowledge Test completed by survey | Change from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, self-management, remote patient monitoring