Patient Navigator for Type 1 Diabetes

(EquiT1D Trial)

Overseen By Celeste Thomas, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Inability to share CGMS data

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to see if using technology, with the help of a Patient Navigator, can help address disparities, improve outcomes, and promote healthcare equity in type 1 diabetes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the Patient Navigator treatment for type 1 diabetes differ from other treatments?

The Patient Navigator treatment is unique because it focuses on improving patients' adherence to their diabetes care plan and increasing their knowledge about the disease, rather than directly altering blood sugar levels like traditional medications. This approach helps patients better manage their condition by guiding them through the healthcare system and encouraging proactive self-care. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Patient Navigator for Type 1 Diabetes?

Research shows that patient navigation helps people with type 1 diabetes stick to their treatment plans better, understand their condition more, and take more interest in managing their health. This suggests that patient navigators can be effective in improving diabetes care. ^{1 6 7 8 9}

Who Is on the Research Team?

Celeste Thomas, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes. Specific eligibility criteria are not provided, but typically participants would need to have a confirmed diagnosis and may be required to meet certain health conditions.

Inclusion Criteria

Informed Consent

I use or have a prescription for a continuous glucose monitoring system.

I am between 14 and 64 years old.

Exclusion Criteria

I am unable or unwilling to share my glucose monitor data.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive real-time CGMS and support from a Patient Navigator

48 months

Monthly check-ins

Follow-up

Participants are monitored for changes in diabetes distress, quality of life, and self-management practices

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigator

Trial Overview The study is testing whether technology, aided by a Patient Navigator—a guide who helps patients manage their healthcare—can reduce disparities and improve health outcomes in those with Type 1 Diabetes.

How Is the Trial Designed?

Group I: Patient Navigator Experimental Treatment 1 Intervention

Patient Navigator will provide additional support to participants using their standard of care CGM device.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Patient navigation by nurses significantly improved glycemic control, with 24.3% of participants showing better blood sugar levels after a year of follow-up, indicating its efficacy in managing type 1 diabetes.

The intervention also enhanced diabetes knowledge and self-care adherence in 53.9% of participants, suggesting that structured support can lead to better health outcomes for individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of patient navigation on glycemic control, adherence to self-care and knowledge about diabetes: an intervention study. Foppa, L., Nemetz, B., de Matos, R., et al.[2023]

Patient navigators can improve certain health outcomes for patients with chronic kidney disease (CKD) and kidney failure, such as enhancing transplant workup and listing, increasing peritoneal dialysis utilization, and boosting patient knowledge, based on a review of 17 studies.

However, many studies had a high risk of bias and did not demonstrate benefits across all outcomes, highlighting the need for more rigorous randomized controlled trials to assess the overall efficacy and cost-effectiveness of navigator programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigators for CKD and Kidney Failure: A Systematic Review. Taha, A., Iman, Y., Hingwala, J., et al.[2022]

The pilot study involved 75 elderly patients, primarily female, who received patient navigation services from a social worker, helping them effectively navigate the complex US healthcare system.

Patients reported finding the navigation services very helpful, and physicians recognized the PN as a valuable addition to the practice, indicating that integrating patient navigation into primary care can significantly benefit those with complex healthcare needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the patient navigator approach to meet the needs of primary care. Ferrante, JM., Cohen, DJ., Crosson, JC.[2022]

The breast cancer navigation (BCN) program significantly improved physician workflows, with many physicians stating it made their day easier and enhanced care coordination and patient experience.

Patients also reported high satisfaction with the support they received during diagnosis communication, indicating that the BCN program effectively met their needs during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. Dillon, EC., Kim, P., Li, M., et al.[2021]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

The New-Onset Diabetes Educator (NODE) web application significantly improved diabetes knowledge among child/caregiver dyads, with post-intervention scores showing a medium effect size (Δ=0.56) compared to standard education methods.

NODE was found to be user-friendly and feasible, suggesting it could be an effective tool for enhancing diabetes self-management education at the time of diagnosis, potentially leading to better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. Bernier, A., Fedele, D., Guo, Y., et al.[2023]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The impact of patient navigation on glycemic control, adherence to self-care and knowledge about diabetes: an intervention study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Patient Navigators for CKD and Kidney Failure: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Translating the patient navigator approach to meet the needs of primary care. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Support, a self-guided online type 1 diabetes self-management education and support web application-a mixed methods study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Do-It-Yourself Artificial Pancreas Systems: A Review of the Emerging Evidence and Insights for Healthcare Professionals. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. [2018]