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Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanics With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03799796
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
La Trobe University
Information provided by (Responsible Party):
Michelle Litchman, University of Utah

Brief Summary:
Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Flash Glucose Monitoring with Online Peer Support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanic Spanish-Speaking People With Type 2 Diabetes
Actual Study Start Date : January 6, 2019
Actual Primary Completion Date : July 27, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Flash Glucose Monitoring with Online Peer Support
Pre-Test-Post-Test
Behavioral: Flash Glucose Monitoring with Online Peer Support
Hispanic Adults who are Spanish-Speaking with type 2 diabetes who are not using insulin will be asked to use flash glucose monitoring and to sign up for an moderated online peer support group where they can ask questions and share progress.
Other Name: Abbott Freestyle Libre




Primary Outcome Measures :
  1. Time-in-Range [ Time Frame: 12 weeks ]
    Average glucose level and number of minutes spent between 70-180 mg/dL


Secondary Outcome Measures :
  1. A1C [ Time Frame: 12 weeks ]
    Glycosylated hemoglobin

  2. Online peer support engagement [ Time Frame: 12 weeks ]
    Survey, Activity in online peer support group



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥21 years
  • Self-report as Hispanic
  • Able to communicate in Spanish
  • Clinical diagnosis of T2D and HbA1c ≥8% per clinic records
  • Willing to wear a flash glucose monitor for 12 weeks
  • Access to the internet and willing to engage in an online peer support community
  • Willing to avoid Vitamin C 500 mg and Aspirin 325 mg or greater daily
  • Not using insulin

Exclusion Criteria:

  • Non-Spanish speaking
  • Using insulin
  • Already using a continuous glucose monitor or flash glucose monitor in previous 6 months
  • Participation in other diabetes clinical trials
  • Alcohol or drug abuse/dependency
  • Severe illness (physical or mental health), cognitive impairment, high dose steroids, hospitalized more than 2 times in past 12 months or other impairment that would, in the opinion of the investigators, interfere with ability to complete the study
  • Uncorrected hearing or vision impairment
  • Life expectancy <6 months

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): NCT03799796


Locations
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United States, Utah
University of Utah College of Nursing
Salt Lake City, Utah, United States, 841112
Sponsors and Collaborators
University of Utah
La Trobe University
Investigators
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Principal Investigator: Michelle L Litchman, PhD, FNP-BC University of Utah College of Nursing
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Responsible Party: Michelle Litchman, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03799796    
Other Study ID Numbers: ADC-SRR-IIS-18-23
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data can be shared upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Michelle Litchman, University of Utah:
flash glucose monitoring
online peer support
Hispanic
Spanish-Speaking
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases