NCT03799796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

January 9, 2019

Last Update Submit

October 19, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

flash glucose monitoringonline peer supportHispanicSpanish-Speaking

Outcome Measures

Primary Outcomes (1)

  • Time-in-Range

    Average glucose level and number of minutes spent between 70-180 mg/dL

    12 weeks

Secondary Outcomes (2)

  • A1C

    12 weeks

  • Online peer support engagement

    12 weeks

Study Arms (1)

Flash Glucose Monitoring with Online Peer Support

EXPERIMENTAL

Pre-Test-Post-Test

Behavioral: Flash Glucose Monitoring with Online Peer Support

Interventions

Flash Glucose Monitoring with Online Peer SupportBEHAVIORAL

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.

Also known as: Abbott Freestyle Libre
Flash Glucose Monitoring with Online Peer Support

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah College of Nursing

Salt Lake City, Utah, 841112, United States

Location

Related Publications (1)

  • Ng AH, Greenwood DA, Iacob E, Allen NA, Ferrer M, Rodriguez B, Litchman ML. Examining a Continuous Glucose Monitoring Plus Online Peer Support Community Intervention to Support Hispanic Adults With Type 2 Diabetes: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2022 Feb 24;11(2):e31595. doi: 10.2196/31595.

    PMID: 35200153DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michelle L Litchman, PhD, FNP-BC

    University of Utah College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 10, 2019

Study Start

January 6, 2019

Primary Completion

July 27, 2020

Study Completion

August 30, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

US(1)