Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03799796 |
Other study ID # |
ADC-SRR-IIS-18-23 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 6, 2019 |
Est. completion date |
August 30, 2020 |
Study information
Verified date |
October 2020 |
Source |
University of Utah |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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. FGM involves wearing an interstitial glucose sensor that is placed
on the upper arm and a reader. When an individual wants to check their glucose level, they
waive or scan the reader over their sensor and a glucose history, current glucose level, and
projected glucose trend is displayed. 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.
Little is known about the uses, benefits, and limitations of online peer support in the
context of learning how to use diabetes technology, such as FGM. Hispanic, Spanish speaking
individuals are at high risk for T2D and associated morbidity and mortality. Hispanics are
more likely to die from diabetes compared to Caucasian counterparts. The investigators
propose to address gaps in diabetes care for Hispanic individuals by conducting a pilot trial
of an online peer support intervention using an online peer facilitator to augment the use of
FGM. The online peer facilitator will be Hispanic and bilingual in English and Spanish with
substantial knowledge of diabetes and FGM. Our intervention is culturally appropriate to
address the biobehavioral and biopsychosocial needs of Hispanic individuals. The
investigators anticipate the additional support provided by the online peer facilitator will
encourage healthy eating habits and physical activity behaviors in Hispanic individuals with
T2D. Our research team is experienced with community-based participatory research in both
diabetes online peer support communities and Hispanic populations using technology to support
T2D.
Examining online peer support communities to augment diabetes care in Hispanic Spanish
speaking individuals is a promising, exciting, and innovative area of research that has not
yet been explored. This proposed study contains several novel components. First, using online
peer support communities is low-cost and easily accessible, making this intervention more
translatable in the clinical setting while adding to the toolkit that already exists for
diabetes care. Second, using FGM in a population not using insulin is forward thinking.
Empowering people with their own glucose data, early in the course of their diabetes, may
change the trajectory of diabetes management. The research team received PCORI
pipeline-to-proposal funding (tiers I-III) to develop a research question via a community
advisory board (CAB) in partnership with the diabetes online peer support community. The CAB
included researchers, clinicians, and people with diabetes, both English and Spanish
speaking. This study will address important questions identified by people affected by
diabetes.
Aim 1 Explore the relationship between engagement in an online peer support intervention with
clinical and behavioral outcomes in Hispanic, Spanish speaking individuals with T2D using
flash glucose monitoring for 12 weeks
Method. A one group, pre-post evaluation of Hispanic, Spanish speaking individuals (N=43)
recruited from a health center in Utah.
Primary outcome: Time-in-range (average glucose level and number of minutes in
70mg/dl-180mg/dl in last 10 days of the study minus average glucose level and number of
minutes in 70mg/dl-180mg/dl for 10 days baseline) between baseline and 12 weeks.
Secondary outcomes: Change in A1C from baseline to 12 weeks. Online peer support engagement
(measured by survey and Facebook activity), Frequency of FGM scans. Change in self-reported
self-management behaviors, self-efficacy and quality of life between baseline and 12 weeks.
Hypothesis. Increased engagement in the online peer support intervention will be associated
with improved clinical, behavioral and psychosocial outcomes after 12 weeks of FGM.
Aim 2. Evaluate the acceptability and feasibility of an online peer support intervention for
Hispanic Spanish speaking individuals with T2D to learn how to use flash glucose monitoring
to make changes to meal and activity choices.
Method. Qualitative and quantitative analysis for measures of use of and satisfaction with
flash glucose sensors, eligible participant acceptance of flash glucose sensors, and dropout
rates, including causes for drop out, and online peer support engagement through platform
analytics. A semi-structured interview will be conducted with participants at the end of the
intervention explore their experiences during engagement with the online peer support
community.
Hypothesis. Online peer support engagement will be associated with satisfaction with FGM and
number of daily scans.