Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95833
      • Sutter Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control-usual care; Nurse care coordination in a telephonic diabetes disease management program
Experimental: 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	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of incorporating the intervention into the existing program	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	3 months
Participant engagement with telehealth technology	# of participants that complete the 12 week program, # of participants that upload the blood glucose meter values to the technology	3 months

Collaborators and Investigators

• Sponsor: Sutter Health
• Collaborators: GE Healthcare; University of California, Davis; LifeScan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 20, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: self-management; Type 2 diabetes; remote patient monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1208042ex