Group Visits for Type 1 Diabetes
Trial Summary
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 data supports the effectiveness of the treatment Group Visits for Type 1 Diabetes?
Research shows that shared medical appointments (SMAs), which are similar to group visits, can improve diabetes management by enhancing patient education and self-management skills. These appointments have been found to help patients achieve better control over their diabetes-related health measures, like blood sugar levels.12345
Is it safe to participate in group visits for managing type 1 diabetes?
How is the treatment of group visits for Type 1 Diabetes different from other treatments?
Group visits for Type 1 Diabetes involve shared medical appointments where patients receive diabetes education in a group setting along with individual consultations. This approach is unique because it combines the benefits of peer support and education with personalized medical care, potentially improving access and quality of care for chronic illness management.34678
What is the purpose of this trial?
The investigators propose to conduct a pilot prospective cohort study to assess the impact of shared medical appointments (SMA) visits in underserved youth with poorly controlled type 1 diabetes (T1D). The trial will employ an enrollment visit, SMA visits every 3 months over a 12 month study period, followed by a 6-month observational period to assess feasibility and acceptability of SMA and the impact on glycemic control, self-management skills, and health related quality of life.
Research Team
Shideh Majidi, MD
Principal Investigator
Children's National Research Institute
Eligibility Criteria
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
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
Treatment Details
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