Recruiting

Diabetes Equity

Sponsor:

Sinai Health System

Code:

NCT06040463

Conditions

Diabetes

Diabetes Mellitus

Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diabetes Self-Management Training (DSMT)

Remote Glucose Monitoring (RGM)

Community Health Worker tailored support

Study Details

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.

Conditions

Diabetes

Diabetes Mellitus

Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 2

Study ID

NCT06040463

Start date

Oct 23, 2023

Status verified date

Sep, 2023

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->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.

experimental: Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW)

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.

experimental: Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT)

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).

experimental: Diabetes Self-Management Training > Standard of Care (DSMT->SOC)

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.

experimental: Diabetes Self-Management Training > Community Health Worker (DSMT->CHW)

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.

experimental: Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->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.

Interventions

Diabetes Self-Management Training (DSMT)

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)

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 support

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.

Primary outcome measure

  • Change in A1c [ Time Frame: Baseline (time = 0); 6 months (time = 1); 12 months (time = 2) ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Chicago, Illinois, United States, 60608

Contacts

More Information

Sponsor

Sinai Health System

Last update posted

Dec 7, 2023

Last verified

Sep, 2023

Keywords

  • implementation science
  • optimization study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sinai Health System on 2023-12-07.