Diabetes MellitusNCT03004664
Comparing Program Options for Latinos With Diabetes
An observational study of Diabetes Mellitus, run by University of New Mexico at 2 sites in United States.
Trial summary
BACKGROUND AND SIGNIFICANCE: Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-management strategies, many people are not able to do so effectively and cannot control their diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Support Empowerment Model and The Chronic Care Model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 452 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2017to 30 Jan 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: STUDY POPULATION: Patients will be identified through the diabetes programs at 2 sites: a total of 240 patient-caregiver pairs will be recruited: patients and a corresponding caregiver of each patient.
Who may be able to join
- Patient Participants:
- Adults (men and women) who have been identified by a provider as having pre-diabetes (A1c 5.7-6.4) or diabetes (A1c 6.5 or above)
- Enter one of the two diabetes programs during the study
- Self-identify as "Latino"
- Can identify a social support or key member of their social network who will agree to participate with them
- Are not pregnant (participants who become pregnant during the study will be excluded)
Show all 10Show fewer
- Have household income 250% of the Federal Poverty Level (FPL) or below.
- Social support participants:
- Adults
- Individuals who are identified by the patient participants as their social support
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
- Participants who become pregnant during the study will be excluded. At enrollment and before each data collection appointment, female patient participants will be screened to specifically exclude those who are pregnant. There is no risk to a pregnant woman or a fetus entailed in participation in this study because the study only involves data collection from individuals who have been instructed to participate in a diabetes self-management program by their provider. However, pregnant individuals will be excluded because pregnancy could impact outcomes in a way that will influence scientific analysis of diabetes self-management.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
One Hope Centro de Vida Health Center
Albuquerque, New Mexico, 87108
University of New Mexico Hospital
Albuquerque, New Mexico, 87131
About this study
Official title: A Patient-Centered Framework to Test the Comparative Effectiveness of Culturally and Contextually Appropriate Program Options for Latinos With Diabetes From Low-Income Households
BACKGROUND AND SIGNIFICANCE:
Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-management strategies, many people are not able to do so effectively and cannot control their diabetes. Studies show that culturally competent self-management programming can help, but patients in preliminary research indicated that not all programs sufficiently respect patients' cultural values or account for their socio-economic limitations.
Read more
STUDY AIMS:
This project will compare two models for culturally competent diabetes self-management programming. The hypothesis is that the program model that best considers patient culture and accommodates patient socio-economic circumstances will have the best outcomes.
COMPARATORS:
2 diabetes self-management program models used by many Latino patients from low-income households in Albuquerque, New Mexico
- The Diabetes Self-Management Support Empowerment Model
- The Chronic Care Model
STUDY POPULATION:
Patients will be 240 individuals who consider themselves to be Latino and who are from low-income households. In addition, 240 patients will identify a corresponding social support to participate with them. Outcomes will be measured based on the 240 patient participants. Social support data will be measured as a covariate to understand patient outcomes.
PRIMARY OUTCOME:
Improved capacity for diabetes self-management measured as diabetes knowledge and patient activation or the ability to put that knowledge into action.
SECONDARY OUTCOME:
Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient stress levels will also be measured using testing of hair samples to identify levels of cortisol as a biological marker for chronic stress.
METHODS:
Statistical calculations will be conducted to make sure that the things being compared are differences in program design and not differences in individual patient characteristics. This study will compare whether the programs improve diabetes health knowledge, ability to act, and A1c, BMI, depression and stress control, and determine which program is the best.
Read the detailed description
BACKGROUND AND SIGNIFICANCE:
Diabetes is a national health priority but diabetes risk is extremely high for Latinos from low-income households. Health guidelines recommend that individuals learn strategies to self-management their diabetes, but getting people to adopt required lifestyle changes is challenging and many people are not able to prevent their pre-diabetes from escalating or to control their diabetes. Systematic reviews show that culturally competent self-management programming can significantly improve diabetes outcomes, and different models for culturally competent programming have been developed.
STUDY AIMS:
The goal of this study is to compare the effectiveness of 2 distinct evidence-based models for culturally competent diabetes health promotion. The hypothesis is that the program model that interfaces most synergistically with patient's culture and everyday life circumstances will have the best diabetes health outcomes.
Aim 1: Characterize the ways that three culturally competent diabetes self-management programs interface with patient culture and socioeconomic context
Aim 2: Measure and compare improvement in patient capacity for diabetes self-management.
Aim 3: Measure and compare patient success at self-management Study Description
OVERALL STUDY DESIGN:
This study follows NIH standards for mixed-method research by integrating data from quantitative and qualitative components of the study in an iterative fashion. The sample size and power estimates are based on realistic evaluation of effect size. Data collection will involve programmatic assessments, interviews, focus groups, surveys, and testing for A1c, BMI, and stress. The research team has the expertise and experience in patient-engaged research necessary to conduct the proposed study and the investigators have an institutional infrastructure that supports the academic and community partnerships necessary for this study.
MAIN COMPONENTS OF THE INTERVENTION AND COMPARATORS:
This study compares 2 diabetes self-management programs that serve a large Latino patient population from low-income households in Albuquerque, New Mexico
- The Diabetes Self-Management Support Empowerment Model
- The Chronic Care Model
PRIMARY \& SECONDARY OUTCOMES:
PRIMARY: Improved capacity for diabetes self-management measured through improvements in diabetes knowledge and diabetes-related patient activation.
SECONDARY: Successful diabetes self-management.
ANALYTIC METHODS:
Descriptive statistics will be calculated to summarize patient characteristics. Means and standard deviations or medians and quartiles will be calculated for continuous variables and will be compared across site by ANOVA or Kruskal-Wallis test, depending on the distribution of the data. Frequencies and percentages will be calculated for categorical variables and will be compared with the chi-square test or Fisher's exact test, as appropriate. Significant differences will be noted and to adjust for possible confounding, those variables will be considered for inclusion as covariates in the analyses for the primary and secondary outcomes in addition to other clinically meaningful variables and their interactions. It is expected that patient characteristics to be similar across the two treatment sites; however, to control for potential differences in the populations, the investigators will adjust for potential confounding covariates by using propensity scores to stratify subjects into groups based on the probability that they attended a particular treatment site given particular demographic characteristics including sex, age, primary language, level of education, nativity, and type of insurance. Patients will be grouped by quintile of propensity score for a total of five strata and each will be analyzed for the primary and secondary outcomes independently. Analyses will be performed in standard statistical software. Propensity score matching allows for causal inference in our non-experimental settings by selecting similar subsets of comparison units between treatment groups across a high-dimensional set of pretreatment characteristics. For qualitative data, the investigators will conduct a rigorous, disciplined, empirical analysis based on plausibility, credibility and relevance. The investigators will conduct a theory-driven qualitative content analysis, reading through transcripts to identify conceptual categories and patterns related to specified domains of inquiry, creating a qualitative codebook, and developing conceptual summaries for each transcript. Following review and summary, the investigators will code transcripts for systematic themes and subthemes and explore interconnections between theme categories and develop a holistic interpretation of the data ("constant comparison").
- Conditions
- Diabetes Mellitus
- Being tested
- Support Empowerment Model, The Chronic Care Model
- Keywords
- Latinos, Low Income, Self Management, Education, Cultural Competence
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support Empowerment ModelBehavioural
Also called Diabetes Self-Management Support Empowerment Model
The DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions.
The Chronic Care ModelBehavioural
the CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design
| Study group | Role | What they receive |
|---|---|---|
| Support Empowerment Model | The Center for Diabetes Education at the University of New Mexico Hospital (CDE) uses the Diabetes Self-Management Support Empowerment Model (DSMS). The DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions. Patients attend a six-week group instructional session with 9 hours of class plus an individual follow-up with a certified diabetes educator. The group sessions have discussion supported by didactic conversation "maps" where the facilitator guides but does not control the conversation based on session thematic goals. Receives: Behavioral: Support Empowerment Model | |
| The Chronic Care Model | One Hope Centro de Vida Diabetes Program is based on the Chronic Care Model (CCM). The CCM involves 6 synergistic domains: 1.) Improved access to care, 2.) Patient self-management support, 3.) Patient decision support, 4.) Care coordination, 5.) Integrated health information systems, and 6.) Access to community resources. To create a holistic care regime, the CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design. Receives: Behavioral: The Chronic Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge
Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire [DKQ])
Measured: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Patients will improve their capacity for diabetes self-management: Measured through change in Patient Activation
Improvement in patient ability to manage their own diabetes measured through changes in score on the Patient Activation Measure (PAM)
Measured: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Secondary outcomes (4)
Patients will successfully self-manage their diabetes measured through change (reduction) in their blood glucose
Reduction in their blood glucose as indicated by A1c 21
Measured: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Patients will successfully self-manage their diabetes measured through change (reduction) in Body Mass Index (BMI)
Reduction in BMI
Measured: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Patients will successfully self-manage their diabetes as measured through change (reduction) in depression
Reduction in depression measured through changes in depression index score in score on Patient Health Questionaire 9-Item set [PHQ-9])
Measured: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Patients will successfully self-manage their diabetes as measured though change (reduction) in chronic stress levels
Improvement in chronic stress levels indicated through testing of hair sample for change (reduction) in circulating level of cortisol
Measured: (baseline to 6 months), (6 months to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completion17 Mar 2021
- Study completion30 Jan 2023
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 MellitusStudies 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
- Prospective
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Janet M Page-Reeves, University of New Mexico
- Investigators
- Janet M Page-Reeves, Ph.D., Principal investigator, University of New Mexico School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004664
- Sponsor's protocol ID
- 16-303
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2016
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Page-Reeves J, Regino L, Murray-Krezan C, Bleecker M, Erhardt E, Burge M, Bearer E, Mishra S. A comparative effectiveness study of two culturally competent models of diabetes self-management programming for Latinos from low-income households. BMC Endocr Disord. 2017 Jul 24;17(1):46. doi: 10.1186/s12902-017-0192-4.
PubMed 28738902
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Centered Framework to Test the Comparative Effectiveness of Culturally and Contextually Appropriate Program Options for Latinos With Diabetes From Low-Income Households
- ClinicalTrials.gov ID
- NCT03004664
- Acronym / sponsor ID
- 16-303
- Conditions
- Diabetes Mellitus
- Keywords
- Latinos, Low Income, Self Management, Education, Cultural Competence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
BACKGROUND AND SIGNIFICANCE:
Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-management strategies, many people are not able to do so effectively and cannot control their diabetes. Studies show that culturally competent self-management programming can help, but patients in preliminary research indicated that not all programs sufficiently respect patients' cultural values or account for their socio-economic limitations.
STUDY AIMS:
This project will compare two models for culturally competent diabetes self-management programming. The hypothesis is that the program model that best considers patient culture and accommodates patient socio-economic circumstances will have the best outcomes.
COMPARATORS:
2 diabetes self-management program models used by many Latino patients from low-income households in Albuquerque, New Mexico
- The Diabetes Self-Management Support Empowerment Model
- The Chronic Care Model
STUDY POPULATION:
Patients will be 240 individuals who consider themselves to be Latino and who are from low-income households. In addition, 240 patients will identify a corresponding social support to participate with them. Outcomes will be measured based on the 240 patient participants. Social support data will be measured as a covariate to understand patient outcomes.
PRIMARY OUTCOME:
Improved capacity for diabetes self-management measured as diabetes knowledge and patient activation or the ability to put that knowledge into action.
SECONDARY OUTCOME:
Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient stress levels will also be measured using testing of hair samples to identify levels of cortisol as a biological marker for chronic stress.
METHODS:
Statistical calculations will be conducted to make sure that the things being compared are differences in program design and not differences in individual patient characteristics. This study will compare whether the programs improve diabetes health knowledge, ability to act, and A1c, BMI, depression and stress control, and determine which program is the best.
Detailed description
BACKGROUND AND SIGNIFICANCE:
Diabetes is a national health priority but diabetes risk is extremely high for Latinos from low-income households. Health guidelines recommend that individuals learn strategies to self-management their diabetes, but getting people to adopt required lifestyle changes is challenging and many people are not able to prevent their pre-diabetes from escalating or to control their diabetes. Systematic reviews show that culturally competent self-management programming can significantly improve diabetes outcomes, and different models for culturally competent programming have been developed.
STUDY AIMS:
The goal of this study is to compare the effectiveness of 2 distinct evidence-based models for culturally competent diabetes health promotion. The hypothesis is that the program model that interfaces most synergistically with patient's culture and everyday life circumstances will have the best diabetes health outcomes.
Aim 1: Characterize the ways that three culturally competent diabetes self-management programs interface with patient culture and socioeconomic context
Aim 2: Measure and compare improvement in patient capacity for diabetes self-management.
Aim 3: Measure and compare patient success at self-management Study Description
OVERALL STUDY DESIGN:
This study follows NIH standards for mixed-method research by integrating data from quantitative and qualitative components of the study in an iterative fashion. The sample size and power estimates are based on realistic evaluation of effect size. Data collection will involve programmatic assessments, interviews, focus groups, surveys, and testing for A1c, BMI, and stress. The research team has the expertise and experience in patient-engaged research necessary to conduct the proposed study and the investigators have an institutional infrastructure that supports the academic and community partnerships necessary for this study.
MAIN COMPONENTS OF THE INTERVENTION AND COMPARATORS:
This study compares 2 diabetes self-management programs that serve a large Latino patient population from low-income households in Albuquerque, New Mexico
- The Diabetes Self-Management Support Empowerment Model
- The Chronic Care Model
PRIMARY \& SECONDARY OUTCOMES:
PRIMARY: Improved capacity for diabetes self-management measured through improvements in diabetes knowledge and diabetes-related patient activation.
SECONDARY: Successful diabetes self-management.
ANALYTIC METHODS:
Descriptive statistics will be calculated to summarize patient characteristics. Means and standard deviations or medians and quartiles will be calculated for continuous variables and will be compared across site by ANOVA or Kruskal-Wallis test, depending on the distribution of the data. Frequencies and percentages will be calculated for categorical variables and will be compared with the chi-square test or Fisher's exact test, as appropriate. Significant differences will be noted and to adjust for possible confounding, those variables will be considered for inclusion as covariates in the analyses for the primary and secondary outcomes in addition to other clinically meaningful variables and their interactions. It is expected that patient characteristics to be similar across the two treatment sites; however, to control for potential differences in the populations, the investigators will adjust for potential confounding covariates by using propensity scores to stratify subjects into groups based on the probability that they attended a particular treatment site given particular demographic characteristics including sex, age, primary language, level of education, nativity, and type of insurance. Patients will be grouped by quintile of propensity score for a total of five strata and each will be analyzed for the primary and secondary outcomes independently. Analyses will be performed in standard statistical software. Propensity score matching allows for causal inference in our non-experimental settings by selecting similar subsets of comparison units between treatment groups across a high-dimensional set of pretreatment characteristics. For qualitative data, the investigators will conduct a rigorous, disciplined, empirical analysis based on plausibility, credibility and relevance. The investigators will conduct a theory-driven qualitative content analysis, reading through transcripts to identify conceptual categories and patterns related to specified domains of inquiry, creating a qualitative codebook, and developing conceptual summaries for each transcript. Following review and summary, the investigators will code transcripts for systematic themes and subthemes and explore interconnections between theme categories and develop a holistic interpretation of the data ("constant comparison").
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Support Empowerment Model | – | Behavioral: Support Empowerment ModelThe Center for Diabetes Education at the University of New Mexico Hospital (CDE) uses the Diabetes Self-Management Support Empowerment Model (DSMS). The DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions. Patients attend a six-week group instructional session with 9 hours of class plus an individual follow-up with a certified diabetes educator. The group sessions have discussion supported by didactic conversation "maps" where the facilitator guides but does not control the conversation based on session thematic goals. |
| The Chronic Care Model | – | Behavioral: The Chronic Care ModelOne Hope Centro de Vida Diabetes Program is based on the Chronic Care Model (CCM). The CCM involves 6 synergistic domains: 1.) Improved access to care, 2.) Patient self-management support, 3.) Patient decision support, 4.) Care coordination, 5.) Integrated health information systems, and 6.) Access to community resources. To create a holistic care regime, the CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STUDY POPULATION: Patients will be identified through the diabetes programs at 2 sites: a total of 240 patient-caregiver pairs will be recruited: patients and a corresponding caregiver of each patient.
Key inclusion criteria (10 listed)
- Adults (men and women) who have been identified by a provider as having pre-diabetes (A1c 5.7-6.4) or diabetes (A1c 6.5 or above)
- Enter one of the two diabetes programs during the study
- Self-identify as "Latino"
- Can identify a social support or key member of their social network who will agree to participate with them
- Are not pregnant (participants who become pregnant during the study will be excluded)
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
- Participants who become pregnant during the study will be excluded. At enrollment and before each data collection appointment, female patient participants will be screened to specifically exclude those who are pregnant. There is no risk to a pregnant woman or a fetus entailed in participation in this study because the study only involves data collection from individuals who have been instructed to participate in a diabetes self-management program by their provider. However, pregnant individuals will be excluded because pregnancy could impact outcomes in a way that will influence scientific analysis of diabetes self-management.
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 |
|---|---|---|
| Support Empowerment ModelAlso: Diabetes Self-Management Support Empowerment ModelThe DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions. | Behavioural | Support Empowerment Model |
| The Chronic Care Modelthe CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design | Behavioural | The Chronic Care Model |
Primary outcome
Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge
Time frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire [DKQ])
Patients will improve their capacity for diabetes self-management: Measured through change in Patient Activation
Time frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Improvement in patient ability to manage their own diabetes measured through changes in score on the Patient Activation Measure (PAM)
4 secondary outcomes
Patients will successfully self-manage their diabetes measured through change (reduction) in their blood glucose
Time frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Patients will successfully self-manage their diabetes measured through change (reduction) in Body Mass Index (BMI)
Time frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Patients will successfully self-manage their diabetes as measured through change (reduction) in depression
Time frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Patients will successfully self-manage their diabetes as measured though change (reduction) in chronic stress levels
Time frame: (baseline to 6 months), (6 months to 12 months)
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 17 Dec 2024.
- Derived from this study: PubMed 28738902Page-Reeves J, Regino L, Murray-Krezan C, Bleecker M, Erhardt E, Burge M, Bearer E, Mishra S. A comparative effectiveness study of two culturally competent models of diabetes self-management programming for Latinos from low-income households. BMC Endocr Disord. 2017 Jul 24;17(1):46. doi: 10.1186/s12902-017-0192-4.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty
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.
Janet M Page-Reeves, Ph.D. principal investigator
University of New Mexico School of Medicine
2 sites 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, run by University of New Mexico at 2 sites 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 10 inclusion and 5 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 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge (time frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)). The study lists 2 primary outcomes in all. 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 NCT03004664, 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 17 Dec 2024.