Group Visits for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether group medical appointments (also known as SMA Visits) can help underserved children with type 1 diabetes (T1D) manage their condition more effectively. Participants will attend shared medical appointments every three months over a year. The study aims to determine if this improves blood sugar control, self-management skills, and overall quality of life. Suitable candidates have had T1D for at least a year, rely on insulin injections, have public healthcare insurance, and have struggled to maintain stable blood sugar levels in the past year. As an unphased trial, this study provides a unique opportunity to explore innovative care approaches that could enhance daily life for children with T1D.
Will I have to stop taking my current medications?
The trial requires that participants do not use any non-insulin diabetes medications to control blood glucose levels. If you are taking such medications, you would need to stop them to join the study.
What prior data suggests that shared medical appointments are safe for youth with type 1 diabetes?
Previous studies have shown that shared medical appointments (SMAs) are safe and well-tolerated. Research indicates that SMAs, or group doctor visits, typically last 90 minutes or more and serve for regular check-ups or follow-up care. They have been used with diabetes patients, and no major safety issues have been reported.
A review of SMAs for diabetes patients found no significant negative effects, suggesting that these group visits are generally safe for people with diabetes. Although SMAs are not a medication or a new medical procedure, they provide an alternative way for patients to receive care and learn from each other.
For those considering joining a trial with SMAs, existing evidence suggests that participation is safe, especially since they involve routine medical care in a group setting.12345Why are researchers excited about this trial?
Researchers are excited about the Group Visits for Type 1 Diabetes because they offer a fresh approach to managing the condition by incorporating shared medical appointments (SMAs). Unlike the traditional one-on-one appointments, these group visits allow underserved youth with Type 1 Diabetes to meet every three months alongside their caregivers and healthcare providers. This setup fosters peer support and shared learning, potentially leading to better disease management and improved outcomes. By creating a community environment, the hope is that patients will feel more supported and engaged in their care, which could translate to better adherence to treatment plans and improved overall health.
What evidence suggests that shared medical appointments are effective for type 1 diabetes?
Research shows that shared medical appointments (SMAs), which participants in this trial may receive, can help people with diabetes. Studies have found that SMAs increase patient satisfaction and enhance skills for managing the condition. For those with type 1 diabetes, SMAs have been linked to better control of blood sugar levels. Patients often benefit from the group setting, which provides social support and shared learning. Evidence also suggests that SMAs can improve quality of life by making care more accessible and engaging.13456
Who Is on the Research Team?
Shideh Majidi, MD
Principal Investigator
Children's National Research Institute
Are You a Good Fit for This Trial?
This trial is for underserved youth aged 8-11 with poorly controlled type 1 diabetes (T1D), who have public healthcare insurance, speak English, and are managed on insulin injections. Participants must be Non-Hispanic Black or Latinx and have had an A1c value over 8% in the past year. Those using insulin pumps, with significant cognitive issues or major psychiatric disorders, taking non-insulin diabetes meds, or involved in other studies can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment
Enrollment visit where consent is obtained and baseline data is collected using a blinded CGM
Shared Medical Appointments (SMA)
Participants attend group visits every 3 months over a 12-month period to improve diabetes management
Follow-up
Participants are monitored for long-term effects of the intervention during routine clinical care
What Are the Treatments Tested in This Trial?
Interventions
- SMA Visits
- Standard Visits
SMA Visits is already approved in United States, European Union for the following indications:
- Type 1 Diabetes
- Type 2 Diabetes
- Type 2 Diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor
American Diabetes Association
Collaborator
DexCom, Inc.
Industry Sponsor
Kevin Sayer
DexCom, Inc.
Chief Executive Officer since 2015
Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University
Dr. Shelly Lane
DexCom, Inc.
Chief Medical Officer since 2023
MD from University of California, San Diego