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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Patient Navigator (a support program) can help individuals with type 1 diabetes better manage their condition using technology. The Patient Navigator will guide participants who already use a continuous glucose monitor (CGM) to determine if it improves their health and reduces hospital visits. This trial may suit those with type 1 diabetes who have been hospitalized for diabetic ketoacidosis (a serious diabetes complication) twice in the last five years or have recently experienced consistently high blood sugar levels. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care solutions.

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.

What prior data suggests that this Patient Navigator is safe for use in type 1 diabetes?

Research shows that a Patient Navigator for individuals with type 1 diabetes is likely safe and well-received. Previous studies found that Patient Navigators improve blood sugar levels and enhance patients' understanding of diabetes management. These studies reported no major safety concerns or serious side effects. Participants generally found the support from Patient Navigators helpful in managing their condition. While this trial will incorporate technology with a Patient Navigator, past research suggests this approach is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigator because it offers a unique approach for managing Type 1 Diabetes by enhancing support for patients using continuous glucose monitoring (CGM) devices. Unlike traditional treatments that focus solely on insulin therapy and monitoring blood sugar levels, the Patient Navigator is designed to provide personalized guidance and support, helping patients better understand and manage their condition in real-time. This added layer of support aims to improve adherence to treatment plans and empower patients, potentially leading to better health outcomes and quality of life for those living with Type 1 Diabetes.

What evidence suggests that using a Patient Navigator is effective for type 1 diabetes?

Research has shown that a Patient Navigator can significantly assist people in managing type 1 diabetes. In this trial, participants will receive support from a Patient Navigator alongside their standard CGM device. Studies have found that patients with a Patient Navigator achieved better blood sugar control and maintained more consistent self-care routines. This support also promoted the use of advanced diabetes tools, such as continuous glucose monitors (CGMs), which are crucial for managing the condition. Additionally, patients reported a better understanding of their diabetes, leading to healthier outcomes. These findings suggest that a Patient Navigator can be a valuable aid in effectively managing type 1 diabetes. ^{1 2 3 4 6}

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10433589/

The impact of patient navigation on glycemic control ... Our results showed improvement in glycemic control, adherence to self-care, and knowledge of diabetes in the study participants. In addition, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1499267125001200

A Pilot Study of the Feasibility and Acceptability of a Patient ... This pilot study demonstrated a high volume of clinical and health related social needs for youth with type 1 diabetes and their caregivers.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06229236

Assessing Effectiveness of a Diabetes Navigator in ... ... Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.

4. diabetesjournals.org diabetesjournals.org/clinical/article/43/2/240/157477/Development-of-a-Diabetes-Navigator-Toolkit-to

Development of a Diabetes Navigator Toolkit to Support ... Despite the known benefits, CGM and insulin pump therapy are underutilized. Approximately 70% of people with type 1 diabetes use CGM (6), and 60 ...

5. canadianjournalofdiabetes.com canadianjournalofdiabetes.com/article/S1499-2671(25)00120-0/fulltext

A Pilot Study of the Feasibility and Acceptability of a Patient ... Our aim in this study was to assess the feasibility and acceptability of a patient navigator (PN) in a pediatric type 1 diabetes (T1D) clinic.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5699176/

Patient navigation to improve diabetes outpatient care at a ... On average, patients who participated in the navigation program showed a clinically significant reduction in A1C level, scheduled more ...