Diabetes Mellitus, Type 2NCT03799796
Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanics With Type 2 Diabetes
A study testing Flash Glucose Monitoring with Online Peer Support in people with Diabetes Mellitus, Type 2, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Flash Glucose Monitoring with Online Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2019to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah College of Nursing
Salt Lake City, Utah, 841112
About this study
Official title: Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanic Spanish-Speaking People With Type 2 Diabetes
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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Flash Glucose Monitoring with Online Peer Support
- Keywords
- flash glucose monitoring, online peer support, Hispanic, Spanish-Speaking
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flash Glucose Monitoring with Online Peer SupportBehavioural
Also called Abbott Freestyle Libre
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.
| Study group | Role | What they receive |
|---|---|---|
| Flash Glucose Monitoring with Online Peer Support | Experimental | Pre-Test-Post-Test Receives: Behavioral: Flash Glucose Monitoring with Online Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-in-Range
Average glucose level and number of minutes spent between 70-180 mg/dL
Measured: 12 weeks
Secondary outcomes (2)
A1C
Glycosylated hemoglobin
Measured: 12 weeks
Online peer support engagement
Survey, Activity in online peer support group
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start6 Jan 2019
- Primary completion27 Jul 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- La Trobe University
- Responsible party
- Principal investigator, Michelle Litchman, University of Utah
- Investigators
- Michelle L Litchman, PhD, FNP-BC, Principal investigator, University of Utah College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799796
- Sponsor's protocol ID
- ADC-SRR-IIS-18-23
- Status last verified
- Oct 2020
- First submitted
- 9 Jan 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared upon request.
Publications
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.
PubMed 35200153
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanic Spanish-Speaking People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03799796
- Acronym / sponsor ID
- ADC-SRR-IIS-18-23
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- flash glucose monitoring, online peer support, Hispanic, Spanish-Speaking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- La Trobe University
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flash Glucose Monitoring with Online Peer Support | Experimental | Behavioral: Flash Glucose Monitoring with Online Peer SupportPre-Test-Post-Test |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flash Glucose Monitoring with Online Peer SupportAlso: Abbott Freestyle LibreHispanic 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. | Behavioural | Flash Glucose Monitoring with Online Peer Support |
Primary outcome
Time-in-Range
Time frame: 12 weeks
Average glucose level and number of minutes spent between 70-180 mg/dL
2 secondary outcomes
A1C
Time frame: 12 weeks
Online peer support engagement
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 35200153Ng 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.
- Individual participant dataSharing planned: Undecided. Data can be shared upon request.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle L Litchman, PhD, FNP-BC principal investigator
University of Utah College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flash Glucose Monitoring with Online Peer Support in people with Diabetes Mellitus, Type 2, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-in-Range (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.