Diabetes Mellitus, Type 2NCT04820348
Assessing Adherence to Digital Health Technologies Among Hispanic/Latino Adults With or At Risk of Type 2 Diabetes:
An observational study of Diabetes Mellitus, Type 2 and Depression, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
In an effort to personalize medical care, novel approaches have been used to categorize sub-populations of patients with type 2 diabetes (T2D). These are based on biological and genetic variables, allowing identification of clusters with significantly different clinical characteristics and risks of complications that… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Depression, Anxiety
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 31 Aug 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hispanic/Latino adults with or at high risk of developing type 2 diabetes and who currently use a compatible smartphone will be enrolled.
Who may be able to join
- Adults ≥ 18 years of age at Visit 1.
- Self-reported Hispanic/Latino heritage.
- Self-reported diagnosis of type 2 diabetes OR self-reported as at risk for developing type 2 diabetes OR healthy individuals who are not at-risk or have diabetes (healthy controls).
- Based on staff's judgment, the subject must have a good understanding, ability, and willingness to adhere to the protocol and to participate in the video-recording part of the study.
- Exclusive and continuous use, for the 2 week participation period, of a study-compatible smartphone.
Who cannot join
- Currently taking insulin as treatment for diabetes.
- Pregnant.
- Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation in the trial.
- Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
- Current participation in other trials involving medications or devices.
- Meets criteria for substance use disorders as defined by DSM-5 (e.g., abuse of alcohol, narcotics, or illicit drugs).
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- Self-reported diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia or antisocial personality disorder.
- At high risk for suicide based on staff judgement.
- Neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Assessing Adherence to Digital Health Technologies Among Hispanic/Latino Adults With or At Risk of Type 2 Diabetes: A Feasibility Study
In an effort to personalize medical care, novel approaches have been used to categorize sub-populations of patients with type 2 diabetes (T2D). These are based on biological and genetic variables, allowing identification of clusters with significantly different clinical characteristics and risks of complications that may be more amenable to targeted and precise therapeutic interventions. Increasingly, wearable and other digital health technologies have the potential to capture additional and objective information to support personalized medicine but at present underserved populations have largely been excluded from clinical trials incorporating digital health.
With this study, the Investigators aim to build on prior work using specially trained community health workers ("Community Scientists") to support engagement with an underserved population and to encourage adherence to using wearables and other digital health technologies. In the US, this is especially imperative for the Hispanic/Latino population, which is at high risk for T2D and associated complications.
Read the detailed description
As treatment choices for type 2 diabetes (T2D) evolve from a one-size-fits-all approach into a patient-centered precision medicine model, there is a need for a deeper understanding of the clinically meaningful differences between individuals to inform therapy choice.
Recently there have been new approaches to creating sub-groups of populations with T2D based on biological, psychosocial, and genetic variables which have identified clusters of patients with significantly different clinical characteristics and risk of associated complications. By incorporating personal, wearable digital health technologies, it will become possible to further refine such stratification through the inclusion of additional variables and advances in big data analytics and machine learning. The vision is that identifying sub-groups at high risk of complications early in the course of T2D will help clinicians to offer more effective personalized therapies.
In the US, the prevalence of both diagnosed and undiagnosed T2D is nearly twice as high among Mexican-origin Hispanic/Latino adults compared to non-Hispanic whites. Rates of diabetes-related complications are also higher among Hispanic/Latino adults. T2D is also associated with a high burden of depression. There are independent barriers to the treatment of depression in the Hispanic/Latino population, and a population with comorbid depression and T2D could represent a distinct endophenotype requiring modified treatment plans that address common pathophysiological pathways linking both diseases. Of particular interest is the common presence of anxiety symptoms that can worsen depression prognosis and muddle the diagnostic picture. For this purpose, and to elucidate better endophenotypes in our study, attention will be paid to anxious distress, a specifier of major depressive disorder that could potentially be very pertinent to this population, and bring about somatic complaints, insomnia, and irritability.
Although wearable technologies for self-monitoring such as continuous glucose monitors (CGM) are used in diabetes care, the overwhelming experience has been in type 1 diabetes and insulin-treated type 2 diabetes. There is much less use in individuals with non-insulin treated T2D or those at risk of diabetes. Across all forms of diabetes, minority use of CGM has been consistently and markedly less than in the general population with diabetes.
Diet plays a crucial role in the management of T2D. To design personalized dietary recommendations, it is vital to understand an individual's food behaviors. Mobile health platforms present the opportunity to collect detailed information regarding daily food choices. In this study, data collected through daily food logging and ecological momentary assessment (EMA) on hunger, satisfaction, and satiety will be used to quantify and understand the individual's dietary behaviors and glycemic outcomes.
To summarize the rationale behind this study, developments in precision medicine have allowed for the categorization of individuals with T2D into sub-groups that may be amenable to different therapeutic strategies. However, there is also a need to better understand the impact of behavioral and psychological factors on the risk of progression of T2D and responses to existing and new therapies, especially in the context of development of depressive symptomatology. These may be especially relevant for US minorities, such as Hispanic/Latino adults who have an excess burden of T2D and the associated complications compared to non-Hispanic whites. Digital health has the potential to be of enormous value provided it is acceptable and will be used by underserved communities.
- Conditions
- Diabetes Mellitus, Type 2, Depression, Anxiety, Diet Habit
- Keywords
- Diabetes Mellitus, Type 2, Minority Health, Endophenotype
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression, Anxiety Disorders, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to wearing continuous glucose monitoring (CGM) devices to measure glucose levels.
Unit of measure: Percent of time and percent of days CGM is active during the study period.
Measured: 2 weeks
Secondary outcomes (9)
Adherence to wearing ActiGraph to measure physical activity and sleep.
Unit of measure: Percent of time and percent of days ActiGraph is active during the study period.
Measured: 2 weeks
Adherence to wearing Fitbit to measure physical activity and sleep.
Unit of measure: Percent of time and percent of days Fitbit is active during the study period.
Measured: 2 weeks
Adherence to using the HealthSense app to capture food intake data.
Unit of measure: Percent of days HealthSense app is active during the study period.
Measured: 2 weeks
Adherence to using the MyFitnessPal app to capture food intake data.
Unit of measure: Percent of days MyFitnessPal app is active during the study period.
Measured: 2 weeks
Feasibility of measuring glycemic impact of meal quantity and composition using CGMs.
Unit of measure: Percent of participants from whom data are captured on glucose levels AND food intake.
Measured: 2 weeks
Feasibility of measuring the behavioral impact of meal quantity and composition using food logs and ecological momentary assessment of hunger, satisfaction and satiety.
Unit of measure: Percent of participants from whom data are captured on food intake AND hunger, satisfaction and satiety.
Measured: 2 weeks
Feasibility of assessing depression and anxiety symptoms objectively based on video-recording of the participants.
Unit of measure: Percent of participants from whom data are captured via video-recording on psychological status (depression and anxiety).
Measured: 2 weeks
Feasibility of assessing the prevalence of depression and anxiety with a focus on culturally-specific presentations of distress.
Unit of measure: Percent of participants from whom data are captured on psychological status (depression and anxiety) AND ethnicity.
Measured: 2 weeks
Feasibility of assessing the comorbidity of depressive/anxiety symptoms and type 2 diabetes and the impact of depression and anxiety on diet-medication adherence and lifestyle choices.
Unit of measure: Percent of participants from whom data are captured on depressive/anxiety symptoms AND diabetes status AND diet-medication adherence AND lifestyle choices.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start9 Apr 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University, Carnegie Mellon University, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- David Kerr, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820348
- Sponsor's protocol ID
- IRB-FY2021-54
- Status last verified
- Oct 2022
- First submitted
- 18 Mar 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Adherence to Digital Health Technologies Among Hispanic/Latino Adults With or At Risk of Type 2 Diabetes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04820348
- Acronym / sponsor ID
- IRB-FY2021-54
- Conditions
- Diabetes Mellitus, Type 2, Depression, Anxiety, Diet Habit
- Keywords
- Diabetes Mellitus, Type 2, Minority Health, Endophenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- William Marsh Rice University, Carnegie Mellon University, Baylor College of Medicine
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 Mar 2021 (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.
In an effort to personalize medical care, novel approaches have been used to categorize sub-populations of patients with type 2 diabetes (T2D). These are based on biological and genetic variables, allowing identification of clusters with significantly different clinical characteristics and risks of complications that may be more amenable to targeted and precise therapeutic interventions. Increasingly, wearable and other digital health technologies have the potential to capture additional and objective information to support personalized medicine but at present underserved populations have largely been excluded from clinical trials incorporating digital health.
With this study, the Investigators aim to build on prior work using specially trained community health workers ("Community Scientists") to support engagement with an underserved population and to encourage adherence to using wearables and other digital health technologies. In the US, this is especially imperative for the Hispanic/Latino population, which is at high risk for T2D and associated complications.
Detailed description
As treatment choices for type 2 diabetes (T2D) evolve from a one-size-fits-all approach into a patient-centered precision medicine model, there is a need for a deeper understanding of the clinically meaningful differences between individuals to inform therapy choice.
Recently there have been new approaches to creating sub-groups of populations with T2D based on biological, psychosocial, and genetic variables which have identified clusters of patients with significantly different clinical characteristics and risk of associated complications. By incorporating personal, wearable digital health technologies, it will become possible to further refine such stratification through the inclusion of additional variables and advances in big data analytics and machine learning. The vision is that identifying sub-groups at high risk of complications early in the course of T2D will help clinicians to offer more effective personalized therapies.
In the US, the prevalence of both diagnosed and undiagnosed T2D is nearly twice as high among Mexican-origin Hispanic/Latino adults compared to non-Hispanic whites. Rates of diabetes-related complications are also higher among Hispanic/Latino adults. T2D is also associated with a high burden of depression. There are independent barriers to the treatment of depression in the Hispanic/Latino population, and a population with comorbid depression and T2D could represent a distinct endophenotype requiring modified treatment plans that address common pathophysiological pathways linking both diseases. Of particular interest is the common presence of anxiety symptoms that can worsen depression prognosis and muddle the diagnostic picture. For this purpose, and to elucidate better endophenotypes in our study, attention will be paid to anxious distress, a specifier of major depressive disorder that could potentially be very pertinent to this population, and bring about somatic complaints, insomnia, and irritability.
Although wearable technologies for self-monitoring such as continuous glucose monitors (CGM) are used in diabetes care, the overwhelming experience has been in type 1 diabetes and insulin-treated type 2 diabetes. There is much less use in individuals with non-insulin treated T2D or those at risk of diabetes. Across all forms of diabetes, minority use of CGM has been consistently and markedly less than in the general population with diabetes.
Diet plays a crucial role in the management of T2D. To design personalized dietary recommendations, it is vital to understand an individual's food behaviors. Mobile health platforms present the opportunity to collect detailed information regarding daily food choices. In this study, data collected through daily food logging and ecological momentary assessment (EMA) on hunger, satisfaction, and satiety will be used to quantify and understand the individual's dietary behaviors and glycemic outcomes.
To summarize the rationale behind this study, developments in precision medicine have allowed for the categorization of individuals with T2D into sub-groups that may be amenable to different therapeutic strategies. However, there is also a need to better understand the impact of behavioral and psychological factors on the risk of progression of T2D and responses to existing and new therapies, especially in the context of development of depressive symptomatology. These may be especially relevant for US minorities, such as Hispanic/Latino adults who have an excess burden of T2D and the associated complications compared to non-Hispanic whites. Digital health has the potential to be of enormous value provided it is acceptable and will be used by underserved communities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hispanic/Latino adults with or at high risk of developing type 2 diabetes and who currently use a compatible smartphone will be enrolled.
Key inclusion criteria (5 listed)
- Adults ≥ 18 years of age at Visit 1.
- Self-reported Hispanic/Latino heritage.
- Self-reported diagnosis of type 2 diabetes OR self-reported as at risk for developing type 2 diabetes OR healthy individuals who are not at-risk or have diabetes (healthy controls).
- Based on staff's judgment, the subject must have a good understanding, ability, and willingness to adhere to the protocol and to participate in the video-recording part of the study.
- Exclusive and continuous use, for the 2 week participation period, of a study-compatible smartphone.
Key exclusion criteria (9 listed)
- Currently taking insulin as treatment for diabetes.
- Pregnant.
- Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation in the trial.
- Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
- Current participation in other trials involving medications or devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to wearing continuous glucose monitoring (CGM) devices to measure glucose levels.
Time frame: 2 weeks
Unit of measure: Percent of time and percent of days CGM is active during the study period.
9 secondary outcomes
Adherence to wearing ActiGraph to measure physical activity and sleep.
Time frame: 2 weeks
Adherence to wearing Fitbit to measure physical activity and sleep.
Time frame: 2 weeks
Adherence to using the HealthSense app to capture food intake data.
Time frame: 2 weeks
Adherence to using the MyFitnessPal app to capture food intake data.
Time frame: 2 weeks
Feasibility of measuring glycemic impact of meal quantity and composition using CGMs.
Time frame: 2 weeks
Feasibility of measuring the behavioral impact of meal quantity and composition using food logs and ecological momentary assessment of hunger, satisfaction and satiety.
Time frame: 2 weeks
Feasibility of assessing depression and anxiety symptoms objectively based on video-recording of the participants.
Time frame: 2 weeks
Feasibility of assessing the prevalence of depression and anxiety with a focus on culturally-specific presentations of distress.
Time frame: 2 weeks
Feasibility of assessing the comorbidity of depressive/anxiety symptoms and type 2 diabetes and the impact of depression and anxiety on diet-medication adherence and lifestyle choices.
Time frame: 2 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 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
David Kerr, MD principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Depression, run by Sansum Diabetes Research Institute 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 5 inclusion and 9 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 27 Oct 2022. 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?
Adherence to wearing continuous glucose monitoring (CGM) devices to measure glucose levels. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.