Diabetes Navigator for Type 1 Diabetes

(IMPACT-T1D Trial)

Overseen By Risa Wolf, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Type 2 diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether assistance from a Diabetes Navigator can better support individuals with type 1 diabetes in using advanced diabetes technology compared to standard care. A Diabetes Navigator provides guidance and support for managing diabetes. The trial includes two groups: one receives support from the Diabetes Navigator, while the other receives regular care. Suitable participants have type 1 diabetes, are seen at a Johns Hopkins diabetes clinic, and are not using or not fully utilizing diabetes technology. As an unphased trial, this study offers a unique opportunity for personalized support and potential improvement in diabetes management.

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. It focuses on the use of diabetes technology, so it's best to ask the trial coordinators for more details.

What prior data suggests that the Diabetes Navigator is safe for patients with type 1 diabetes?

Research has shown that using a Diabetes Navigator is safe. Studies indicate that individuals who used a Diabetes Navigator achieved better blood sugar levels and improved self-care. They also gained more knowledge about managing their diabetes. No serious problems or side effects were reported, suggesting that the Diabetes Navigator is user-friendly and helps manage the condition without added risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Navigator because it provides personalized support and guidance in addition to standard care for people with Type 1 Diabetes. Unlike traditional treatments that focus mainly on insulin management and glucose monitoring, the Diabetes Navigator aims to enhance overall diabetes management by offering tailored advice and support. This innovative approach could lead to better outcomes by helping patients navigate their condition more effectively and improve their quality of life.

What evidence suggests that the Diabetes Navigator is effective for type 1 diabetes?

This trial will compare the use of a Diabetes Navigator with standard care for people with type 1 diabetes. Research has shown that a Diabetes Navigator can help individuals manage their blood sugar levels more effectively. In one study, 24.3% of participants improved their blood sugar levels with assistance from a Diabetes Navigator. Another study found that participants not only managed their blood sugar better but also gained more knowledge about handling their diabetes. These findings suggest that a Diabetes Navigator can enhance regular care by helping patients manage their diabetes more effectively. ^{1 4 6 7 8}

Who Is on the Research Team?

Nestoras N Mathioudakis, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 diabetes who are interested in potentially improving their management of the condition. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health conditions and agree to follow the study procedures.

Inclusion Criteria

My diabetes treatment plan is being intensified.

I have been diagnosed with type 1 diabetes.

I am between 5 and 75 years old.

Exclusion Criteria

I have a type of diabetes that is not type 1.

Pregnancy or lactation or planned pregnancy in the next 12 months

Optimally using Diabetes Technology

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Baseline Assessment

Participants are randomized to either the standard care group or the intervention group with a Diabetes Navigator. Baseline assessments are conducted.

1 week

Intervention

Participants in the intervention group receive support from a Diabetes Navigator to improve uptake and use of advanced diabetes technology.

3 months

Regular visits as per study protocol

Follow-up

Participants are monitored for changes in diabetes technology utilization and glycemic control.

3 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Navigator

Trial Overview The trial is testing whether having a Diabetes Navigator—a specialized guide—helps patients with type 1 diabetes better adopt and use advanced technologies for managing their disease compared to standard care without such support.

How Is the Trial Designed?

Group I: Diabetes Navigator Experimental Treatment 1 Intervention

Support and guidance of Diabetes Navigator in addition to standard care

Group II: Standard of Care Active Control 1 Intervention

Standard care provided by the healthcare staff during routine diabetes clinic visits.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

A 5-day structured education program for Type 1 diabetes significantly improved diabetes control, with a notable reduction in glycated hemoglobin (HbA1c) by 0.42% in 63 patients after one year, especially among those with initially high HbA1c levels.

The program also led to a significant decrease in severe hypoglycemia incidents, dropping from 10 episodes in the year prior to just 1 episode after the course, alongside improvements in quality of life measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. Rogers, H., Turner, E., Thompson, G., et al.[2022]

The DAFNE programme significantly improves diabetes management outcomes, such as HbA1c levels and rates of severe hypoglycaemia, for up to 12 months after completion, highlighting its efficacy in educating individuals with Type 1 diabetes.

This study compares group follow-up versus traditional one-to-one visits for DAFNE graduates, aiming to determine the best method to maintain the benefits of the programme, with outcomes measured at 6, 12, and 18 months to ensure comprehensive evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. Dinneen, SF., O' Hara, MC., Byrne, M., 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]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but users face significant risks from potential errors in insulin delivery, which can lead to serious health issues like hyperglycemia or hypoglycemia.

Current safety evaluations of insulin pumps are inadequate, with limited transparency in reporting adverse events and insufficient long-term data on real-world usage, highlighting the need for improved regulatory practices and more comprehensive research on pump therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2018]

In a study of 92 youth with type 1 diabetes using the Minimed 670G hybrid closed loop (HCL) system, 30% discontinued use within 6 months, with higher baseline HbA1c levels significantly predicting discontinuation.

The main barriers to continued use of HCL included difficulties with calibrations, frequent alarms, and the overall workload required to manage the system, indicating a need for interventions to support users, especially those with higher HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Messer, LH., Berget, C., Vigers, T., et al.[2021]

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]

The Diabetes Research in Children Network (DirecNet) has conducted extensive research on type 1 diabetes since 2001, resulting in 28 published studies that evaluate various diabetes management technologies, including glucose meters and continuous glucose monitoring systems.

The network's research also focuses on factors affecting hypoglycemia, such as exercise and diet, and provides valuable data sets and psychosocial questionnaires to the public, enhancing the understanding and management of type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes research in children network:availability of protocol data sets. Ruedy, KJ., Beck, RW., Xing, D., et al.[2023]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06229236

Assessing Effectiveness of a Diabetes Navigator in ... The goal of this randomized control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and ...

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

The impact of patient navigation on glycemic control ... After the intervention, glycemic control improved in 37 (24.3%) participants (p < 0.001), and knowledge about diabetes also improved in 37 (24.3 ...

3. 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 ... This study has identified foundational strategies compiled into a comprehensive diabetes toolkit that can be deployed by a diabetes navigator or ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2365493/

FreeStyle Navigator™ Continuous Glucose Monitoring System ... These encouraging pilot study results support the inclusion of MDI users in longer-term randomized clinical trials of continuous glucose monitors (CGM).

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-10-2020-be234

Patient Navigator for Type 1 Diabetes (EquiT1D 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, ...

6. diabetesjournals.org diabetesjournals.org/care/article/45/8/1907/147068/Safety-and-Glycemic-Outcomes-With-a-Tubeless

Safety and Glycemic Outcomes With a Tubeless Automated ... Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9346983/

Safety and Glycemic Outcomes With a Tubeless Automated ... Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase.

8. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-023-01147-1

The impact of patient navigation on glycemic control ... Our results showed improvement in glycemic control, adherence to self-care, and knowledge of diabetes after an intervention focused on patient ...