Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
LifeScan
GE Healthcare
University of California, Davis
Information provided by (Responsible Party):
Deborah Greenwood, Sutter Health
ClinicalTrials.gov Identifier:
NCT01715649
First received: October 20, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sutter Health:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
    Lab test


Secondary Outcome Measures:
  • Empowerment [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Diabetes Empowerment Scale completed by survey

  • Behavior Change [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Summary of Diabetes Self-Care Behaviors scale completed by survey

  • Knowledge [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Michigan Diabetes Knowledge Test completed by survey


Other Outcome Measures:
  • Feasibility of incorporating the intervention into the existing program [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Participant engagement with telehealth technology [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    # of participants that complete the 12 week program, # of participants that upload the blood glucose meter values to the technology


Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control-usual care
Nurse care coordination in a telephonic diabetes disease management program
Experimental: Intervention
Telehealth remote patient monitoring, structured blood glucose and usual care
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715649

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

No publications provided

Responsible Party: Deborah Greenwood, Diabetes Clinical Nurse Specialist, Sutter Health
ClinicalTrials.gov Identifier: NCT01715649     History of Changes
Other Study ID Numbers: 1208042ex
Study First Received: October 20, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sutter Health:
Type 2 diabetes
self-management
remote patient monitoring

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

ClinicalTrials.gov processed this record on October 19, 2014