Improving Diabetes Equity and Advancing Care Study
IDEA
1 other identifier
interventional
270
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedDecember 7, 2023
September 1, 2023
1.4 years
September 7, 2023
November 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)
Secondary Outcomes (3)
Active Usage of RGM
Data will be exported from the Glooko application monthly for the full 18 months of the trial period.
DSMT Attendance
Attendance data will be collected throughout the entire study period (18 months)
CHW Support Adherence
After rerandomization period (starting at 6 months post enrollment)
Study Arms (6)
Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM)
EXPERIMENTALParticipant 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)
EXPERIMENTALParticipant 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)
EXPERIMENTALParticipant 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)
EXPERIMENTALParticipant 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)
EXPERIMENTALParticipant 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)
EXPERIMENTALParticipant 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.
Interventions
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) 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.
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.
Eligibility Criteria
You may qualify if:
- A diagnosis of type 1 or type 2 diabetes
- + 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Chicago, Illinois, 60608, United States
Related Publications (1)
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.
PMID: 39049044DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2023
First Posted
September 15, 2023
Study Start
October 23, 2023
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
December 7, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Study protocol is currently available. Remaining information will be available upon study completion.