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

148 Participants Needed

Trial Summary

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

Research shows that patient navigation, which is part of the Diabetes Navigator treatment, helps people with type 1 diabetes better follow their treatment plans and understand their condition, leading to improved blood sugar control. ^{1 2 3 4 5}

Is the Diabetes Navigator safe for use in humans?

The Diabetes Navigator, a continuous glucose monitoring system, has been evaluated for use in children with type 1 diabetes. While specific safety data for the Diabetes Navigator itself is not detailed, continuous glucose monitoring systems in general are commonly used and considered safe, though they may have risks like inaccurate readings. It's important to discuss any concerns with your healthcare provider. ^{6 7 8 9 10}

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

The Diabetes Navigator treatment is unique because it involves the use of a continuous glucose monitoring system, which provides real-time glucose data to help manage type 1 diabetes more effectively. This approach differs from traditional methods that rely on periodic blood glucose checks, offering a more comprehensive and less burdensome way to maintain blood sugar levels. ^{6 9 11 12 13}

What is the purpose of this trial?

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 use of advanced diabetes technology among patients with type 1 diabetes.

Research Team

Nestoras N Mathioudakis, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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 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]

References

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. Denmark 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Success Rates in a Diabetes Specialist Nurse-Led Education Programme: Re-setting the Glucostat. [2022]

5. England 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. [2023]

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

Diabetes research in children network:availability of protocol data sets. [2023]

7. United States 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. [2022]

8. Germany 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. [2018]

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

Continuous glucose monitoring in children with type 1 diabetes. [2022]

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

The impact of a decade of changing treatment on rates of severe hypoglycemia in a population-based cohort of children with type 1 diabetes. [2022]

11. 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]

12. 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]

13. 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]