DiabetesIDEANCT06040463
Improving Diabetes Equity and Advancing Care Study
A study testing Diabetes Self-Management Training (DSMT), Remote Glucose Monitoring (RGM) and Community Health Worker tailored support in people with Diabetes and Diabetes Mellitus, run by Sinai Health System at 1 site in United States.
Trial summary
The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 1
- What is being tested?
- Diabetes Self-Management Training (DSMT), Remote Glucose Monitoring (RGM) and Community Health Worker tailored support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 31 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of type 1 or type 2 diabetes
- 18+ years of age
- Able to provide consent
- Identify as African American/Black or Latinx
- most recent HbA1c > 7%,
- Have a smartphone compatible with the Glooko application
- Have completed at least one Center appointment (i.e. current patient)
- Completed at least 3 months of their assigned study condition
Who cannot join
- Already an active user of RGM
- Actively working with a CHW
- Diagnosis of gestational diabetes (without type 1 or type 2)
- Has a Power of Attorney
- Be suffering from Stage-V renal disease or undergoing dialysis.
- Be suffering from a severe form of cardiovascular disease (NYHA Class III and IV)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Chicago, Illinois, 60608
Claude Hall, MA, MHA, 773-257-2749, claude.hall@sinai.org
About this study
The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.
Read the detailed description
Sinai Health System is Illinois' largest private safety-net healthcare system, serving predominantly low-income communities of color with large Medicaid-eligible populations in Chicago. In response to high diabetes rates and community calls for coordinated, multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined services to address the full spectrum of patient medical and non-medical needs. This study seeks to determine the appropriateness and fidelity of three intervention components of a team-based care model for patients served by the Center to define the ideal sequence for improving patient outcomes. Grounded in qualitative methodology and guided by a sequential multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim 2); comparing the effectiveness and determine optimization of intervention components (Aim 3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze Aims 2 \& 3 by conducting descriptive statistics on all variables, giving special attention to outlier values. We will also run bivariate and multivariate analyses across variables of interest and time points to determine the optimal sequence of intervention activities.
- Being tested
- Diabetes Self-Management Training (DSMT), Remote Glucose Monitoring (RGM), Community Health Worker tailored support
- Keywords
- implementation science, optimization study
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self-Management Training (DSMT)Behavioural
Also called Diabetes Self-Management Education and Support (DSMES)
The American Diabetes Association endorses the use of small-group diabetes self-management training (DSMT), for people living with diabetes to improve lifestyle, HbA1c levels, and overall quality of life. A certified diabetes care and education specialist will teach a four-part series of one-hour sessions providing culturally competent group education and discussion for groups of 5-8 patients: Session 1 - Living with diabetes - physiology of diabetes, integrating diabetes into your daily life, long term outcomes of diabetes; Session 2 - Culturally competent food education \& portion control; Session 3 - Tips \& Tricks for dining out and special occasions; Session 4 - Advanced tools and psychosocial implications of living with diabetes. While patients will be encouraged to move through the series together as a cohort, there will be make-up sessions and flexibility to ensure high-quality participation.
Remote Glucose Monitoring (RGM)Behavioural
Remote Glucose Monitoring (RGM) is an automated process of transmitting glucose levels directly from a personal smartphone device to a healthcare provider using a remote data transmitter. Since 2020, Sinai has worked with Glooko Inc. to provide the RGM platform and technical assistance to patients and for Sinai providers to access data remotely. Via the app, patients can: document their glucose levels; sync data from a meter, insulin pump, pen or continuous glucose monitoring device; track their weight; log food and meals; access educational resources; track steps; and track blood pressure. Remotely uploading data provides patients with a direct line to their provider for regular feedback on progress and answers to questions between clinic visits. Patients also receive one one-hour education session on RGM and the Glooko application.
Community Health Worker tailored supportBehavioural
CHWs are frontline public health workers who are trusted members of and/or have an unusually close understanding of the community served. The Center has two bilingual (Spanish/English) CHWs; additional bilingual CHWs will be added to the team to support the proposed study. While approaches will differ slightly depending on the patient and study condition, all patients paired with a CHW will be screened for social needs utilizing a standard social determinants of health (SDoH) screening tool, receive referrals to resources to address unmet social/health needs, and aided in navigating health and social systems.
| Study group | Role | What they receive |
|---|---|---|
| Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM) | Experimental | Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will remain in the RGM group. Receives: Behavioral: Remote Glucose Monitoring (RGM) |
| Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW) | Experimental | Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support. Receives: Behavioral: Remote Glucose Monitoring (RGM); Behavioral: Community Health Worker tailored support |
| Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT) | Experimental | Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being diabetes self-management training (DSMT). Receives: Behavioral: Diabetes Self-Management Training (DSMT); Behavioral: Remote Glucose Monitoring (RGM) |
| Diabetes Self-Management Training > Standard of Care (DSMT->SOC) | Experimental | Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will be directed back to standard of care. Receives: Behavioral: Diabetes Self-Management Training (DSMT) |
| Diabetes Self-Management Training > Community Health Worker (DSMT->CHW) | Experimental | Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a CHW to provide tailored support. Receives: Behavioral: Diabetes Self-Management Training (DSMT); Behavioral: Community Health Worker tailored support |
| Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM) | Experimental | Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM. Receives: Behavioral: Diabetes Self-Management Training (DSMT); Behavioral: Remote Glucose Monitoring (RGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1c
Change in A1c from baseline to the 12-month study end point measured at the patient level. Measure will be collected every 6 months, at a minimum. The 6-month A1c will be used to determine their study condition at the rerandomization poiont.
Measured: Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)
Secondary outcomes (3)
Active Usage of RGM
Active usage will be defined as at least one upload of data within a 30-day period and at least 16 blood glucose entries within a 30-day period.
Measured: Data will be exported from the Glooko application monthly for the full 18 months of the trial period.
DSMT Attendance
We will collect # and proportion of attended DSMT classes by participant.
Measured: Attendance data will be collected throughout the entire study period (18 months)
CHW Support Adherence
Adherence to CHW engagement will include completing the initial education session with a CHW, competing a SDoH screener and at least three phone or in-person touchpoints over the 6-month intervention period.
Measured: After rerandomization period (starting at 6 months post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start23 Oct 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
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 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040463
- Sponsor's protocol ID
- 23-11
- Acronym
- IDEA
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jacobs J, Labellarte P, Margellos-Anast H, Garcia L, Qeadan F, Tingey B, Barnick K, Dougherty A, Wagener C. Improving Diabetes Equity and Advancing Care (IDEA) to optimize team-based care at a safety-net health system for Black and Latine patients living with diabetes: study protocol for a sequential, multiple assignment, randomized trial. Trials. 2024 Jul 24;25(1):504. doi: 10.1186/s13063-024-08346-9.
PubMed 39049044
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Equity and Advancing Care Study
- ClinicalTrials.gov ID
- NCT06040463
- Acronym / sponsor ID
- IDEA / 23-11
- Keywords
- implementation science, optimization study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Sinai Health SystemUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 15 Sep 2023 (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.
The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.
Detailed description
Sinai Health System is Illinois' largest private safety-net healthcare system, serving predominantly low-income communities of color with large Medicaid-eligible populations in Chicago. In response to high diabetes rates and community calls for coordinated, multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined services to address the full spectrum of patient medical and non-medical needs. This study seeks to determine the appropriateness and fidelity of three intervention components of a team-based care model for patients served by the Center to define the ideal sequence for improving patient outcomes. Grounded in qualitative methodology and guided by a sequential multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim 2); comparing the effectiveness and determine optimization of intervention components (Aim 3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze Aims 2 \& 3 by conducting descriptive statistics on all variables, giving special attention to outlier values. We will also run bivariate and multivariate analyses across variables of interest and time points to determine the optimal sequence of intervention activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM) | Experimental | Behavioral: Remote Glucose Monitoring (RGM)Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will remain in the RGM group. |
| Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW) | Experimental | Behavioral: Remote Glucose Monitoring (RGM), Behavioral: Community Health Worker tailored supportParticipant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support. |
| Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT) | Experimental | Behavioral: Diabetes Self-Management Training (DSMT), Behavioral: Remote Glucose Monitoring (RGM)Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being diabetes self-management training (DSMT). |
| Diabetes Self-Management Training > Standard of Care (DSMT->SOC) | Experimental | Behavioral: Diabetes Self-Management Training (DSMT)Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will be directed back to standard of care. |
| Diabetes Self-Management Training > Community Health Worker (DSMT->CHW) | Experimental | Behavioral: Diabetes Self-Management Training (DSMT), Behavioral: Community Health Worker tailored supportParticipant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a CHW to provide tailored support. |
| Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM) | Experimental | Behavioral: Diabetes Self-Management Training (DSMT), Behavioral: Remote Glucose Monitoring (RGM)Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of type 1 or type 2 diabetes
- 18+ years of age
- Able to provide consent
- Identify as African American/Black or Latinx
- most recent HbA1c > 7%,
Key exclusion criteria (6 listed)
- Already an active user of RGM
- Actively working with a CHW
- Diagnosis of gestational diabetes (without type 1 or type 2)
- Has a Power of Attorney
- Be suffering from Stage-V renal disease or undergoing dialysis.
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 |
|---|---|---|
| Diabetes Self-Management Training (DSMT)Also: Diabetes Self-Management Education and Support (DSMES)The American Diabetes Association endorses the use of small-group diabetes self-management training (DSMT), for people living with diabetes to improve lifestyle, HbA1c levels, and overall quality of life. A certified diabetes care and education specialist will teach a four-part series of one-hour sessions providing culturally competent group education and discussion for groups of 5-8 patients: Session 1 - Living with diabetes - physiology of diabetes, integrating diabetes into your daily life, long term outcomes of diabetes; Session 2 - Culturally competent food education \& portion control; Session 3 - Tips \& Tricks for dining out and special occasions; Session 4 - Advanced tools and psychosocial implications of living with diabetes. While patients will be encouraged to move through the series together as a cohort, there will be make-up sessions and flexibility to ensure high-quality participation. | Behavioural | Diabetes Self-Management Training > Community Health Worker (DSMT->CHW), Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM), Diabetes Self-Management Training > Standard of Care (DSMT->SOC), Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT) |
| Remote Glucose Monitoring (RGM)Remote Glucose Monitoring (RGM) is an automated process of transmitting glucose levels directly from a personal smartphone device to a healthcare provider using a remote data transmitter. Since 2020, Sinai has worked with Glooko Inc. to provide the RGM platform and technical assistance to patients and for Sinai providers to access data remotely. Via the app, patients can: document their glucose levels; sync data from a meter, insulin pump, pen or continuous glucose monitoring device; track their weight; log food and meals; access educational resources; track steps; and track blood pressure. Remotely uploading data provides patients with a direct line to their provider for regular feedback on progress and answers to questions between clinic visits. Patients also receive one one-hour education session on RGM and the Glooko application. | Behavioural | Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM), Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT), Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM), Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW) |
| Community Health Worker tailored supportCHWs are frontline public health workers who are trusted members of and/or have an unusually close understanding of the community served. The Center has two bilingual (Spanish/English) CHWs; additional bilingual CHWs will be added to the team to support the proposed study. While approaches will differ slightly depending on the patient and study condition, all patients paired with a CHW will be screened for social needs utilizing a standard social determinants of health (SDoH) screening tool, receive referrals to resources to address unmet social/health needs, and aided in navigating health and social systems. | Behavioural | Diabetes Self-Management Training > Community Health Worker (DSMT->CHW), Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW) |
Primary outcome
Change in A1c
Time frame: Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)
Change in A1c from baseline to the 12-month study end point measured at the patient level. Measure will be collected every 6 months, at a minimum. The 6-month A1c will be used to determine their study condition at the rerandomization poiont.
3 secondary outcomes
Active Usage of RGM
Time frame: Data will be exported from the Glooko application monthly for the full 18 months of the trial period.
DSMT Attendance
Time frame: Attendance data will be collected throughout the entire study period (18 months)
CHW Support Adherence
Time frame: After rerandomization period (starting at 6 months post enrollment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 39049044Jacobs J, Labellarte P, Margellos-Anast H, Garcia L, Qeadan F, Tingey B, Barnick K, Dougherty A, Wagener C. Improving Diabetes Equity and Advancing Care (IDEA) to optimize team-based care at a safety-net health system for Black and Latine patients living with diabetes: study protocol for a sequential, multiple assignment, randomized trial. Trials. 2024 Jul 24;25(1):504. doi: 10.1186/s13063-024-08346-9.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self-Management Training (DSMT), Remote Glucose Monitoring (RGM) and Community Health Worker tailored support in people with Diabetes and Diabetes Mellitus, run by Sinai Health System 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 6 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jackie Jacobs, MPH (7732572553, jackie.jacobs@sinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1c (time frame: Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)). 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 NCT06040463, 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 7 Dec 2023; AzTrials last refreshed its copy on 1 Nov 2026.