Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715649
• Other study ID #: 1208042ex
• Status: Completed
• Phase: N/A
• First received: October 20, 2012
• Last updated: November 17, 2014
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Sutter Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	Sutter Health	Sacramento	California

Sponsors (4)

Lead Sponsor	Collaborator
Sutter Health	GE Healthcare, LifeScan, University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	Hemoglobin A1c	Lab test	Change from baseline to 6 months	No
Secondary	Empowerment	Diabetes Empowerment Scale completed by survey	Change from baseline to 3 months	No
Secondary	Behavior Change	Summary of Diabetes Self-Care Behaviors scale completed by survey	Change from baseline to 3 months	No
Secondary	Knowledge	Michigan Diabetes Knowledge Test completed by survey	Change from baseline to 3 months	No