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Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01715649
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Change from baseline to 6 months ]
    Lab test

Secondary Outcome Measures :
  1. Empowerment [ Time Frame: Change from baseline to 3 months ]
    Diabetes Empowerment Scale completed by survey

  2. Behavior Change [ Time Frame: Change from baseline to 3 months ]
    Summary of Diabetes Self-Care Behaviors scale completed by survey

  3. Knowledge [ Time Frame: Change from baseline to 3 months ]
    Michigan Diabetes Knowledge Test completed by survey

Other Outcome Measures:
  1. Feasibility of incorporating the intervention into the existing program [ Time Frame: 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

  2. Participant engagement with telehealth technology [ Time Frame: 3 months ]
    # of participants that complete the 12 week program, # of participants that upload the blood glucose meter values to the technology

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715649

United States, California
Sutter Health
Sacramento, California, United States, 95833
Sponsors and Collaborators
Sutter Health
GE Healthcare
University of California, Davis
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah Greenwood, Diabetes Clinical Nurse Specialist, Sutter Health
ClinicalTrials.gov Identifier: NCT01715649     History of Changes
Other Study ID Numbers: 1208042ex
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Deborah Greenwood, Sutter Health:
Type 2 diabetes
remote patient monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases