Individual Study / Greenwood et al.; J Med Internet Res. 2015

Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes

Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes

Initiatives -
The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A(1c))—a measure of overall glucose management—between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test. Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2013
End Year
2012
Funding
This research project has research support from the Investigator Initiated Studies program of LifeScan Corporation, Intel-GE Care Innovations, Sutter Institute for Medical Research, The Betty Irene Moore School of Nursing, The Jonas Center for Nursing Excellence, and the University of California Davis, National Center for Advancing Translational Sciences, National Institutes of Health, through grant number UL1 TR 000002.

Design

Study design
Clinical trial cohort

Marker Paper

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;17(7):e178. Published 2015 Jul 21. doi:10.2196/jmir.4112

PUBMED 26199142

Recruitment

Sources of Recruitment
  • Individuals

Number of participants

Number of participants
90
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

The study was conducted between January and October 2013 in a large health care system in California with an established diabetes management program with telephonic nurse care coordination for diabetes population health management.
Selection Criteria
Minimum age
30
Maximum age
70
Newborns
Twins
Countries
  • United States of America
Territory
California
Ethnic Origin
Health Status
  • type 2 diabetes diagnosis
Other criteria
Exclusion criteria identified by medical chart review included: Insulin prescription; Unable to independently self-manage (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment for previous 12 months); and/or Diagnoses of debilitating stroke, heart failure, end-stage renal disease, or legally blind.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of participants

Number of participants
90
Number of participants with biosamples
Data Collection Event
A 2-group randomized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits. The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly.
Start Date
2013-01
End Date
2013-10
Data sources
  • Mobile data collection
    • Smartphone
    • Tablet/laptop