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OpenTrials
Completed

NCT Number: NCT01715649

Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sutter Health

Sacramento, California, 95833, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose

Behavioral

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.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: Change from baseline to 6 months

    Lab test

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sutter Health

Other

Collaborators

  • GE Healthcare
  • LifeScan
  • University of California, Davis

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2012
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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