20 Participants Needed

Group Visits for Type 1 Diabetes

JG
BM
Overseen ByBrynn Marks, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Children's National Research Institute
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The research on shared medical appointments (group visits) for diabetes management does not specifically mention safety concerns, suggesting they are generally considered safe for patients.13456

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

SM

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

My diabetes control has been poor, with an A1c over 8% in the last year.
I have been managing my Type 1 Diabetes with insulin injections for over a year.
Fluent in English as the Dexcom technology is currently available only in English
See 4 more

Exclusion Criteria

The child has severe problems with thinking or major mental health issues.
You have significant health conditions other than type 1 diabetes.
I use an insulin pump to manage my diabetes.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Enrollment visit where consent is obtained and baseline data is collected using a blinded CGM

1 visit
1 visit (in-person)

Shared Medical Appointments (SMA)

Participants attend group visits every 3 months over a 12-month period to improve diabetes management

12 months
4 visits (in-person)

Follow-up

Participants are monitored for long-term effects of the intervention during routine clinical care

6 months
2 visits (in-person)

Treatment Details

Interventions

  • SMA Visits
  • Standard Visits
Trial Overview The study tests shared medical appointments (SMA) every three months for one year to see if they help improve blood sugar control, self-care skills, and quality of life in these kids. After the SMA visits end, there's a six-month observation period to evaluate how well SMAs work and if people like this approach.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: SMA visit intervention armExperimental Treatment1 Intervention
SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver

SMA Visits is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Shared Medical Appointments for:
  • Type 1 Diabetes
  • Type 2 Diabetes
🇪🇺
Approved in European Union as Group Visits for:
  • Type 2 Diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials
227
Recruited
258,000+

American Diabetes Association

Collaborator

Trials
148
Recruited
102,000+

DexCom, Inc.

Industry Sponsor

Trials
151
Recruited
35,700+
Kevin Sayer profile image

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 profile image

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

Shared medical appointments (SMAs) can enhance chronic disease management and preventive care, leading to improved patient trust and perceptions of care quality, as well as better clinical outcomes.
The review analyzed 13 quantitative trials and 13 qualitative studies, highlighting that while SMAs are beneficial, there is no single best model, and further standardization of patient satisfaction measures is needed for optimal implementation.
Shared medical appointments and patient-centered experience: a mixed-methods systematic review.Wadsworth, KH., Archibald, TG., Payne, AE., et al.[2020]
The SHARES study is a large-scale, 2.5-year trial involving multiple Veterans Affairs health systems that aims to evaluate the effectiveness of diabetes shared medical appointments (SMAs) and peer support programs in improving diabetes management outcomes, particularly hemoglobin A1c levels.
The study will compare three groups: those receiving only SMAs, those receiving SMAs plus peer support, and those receiving usual care, providing valuable insights into how these interventions can be implemented effectively in diverse clinical settings.
The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial.Heisler, M., Burgess, J., Cass, J., et al.[2022]
Shared medical appointments (SMAs) significantly improved key health indicators for diabetes patients, including a reduction in hemoglobin A1c levels by an average of 0.55 percentage points and systolic blood pressure by 5.2 mmHg, based on a review of 17 studies.
Despite these improvements in biophysical outcomes, the effectiveness of SMAs on LDL cholesterol levels was not significant, and there was not enough data to assess their impact on patient experience or healthcare costs.
Shared medical appointments for patients with diabetes mellitus: a systematic review.Edelman, D., Gierisch, JM., McDuffie, JR., et al.[2022]

References

Shared medical appointments and patient-centered experience: a mixed-methods systematic review. [2020]
The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial. [2022]
Shared medical appointments for patients with diabetes mellitus: a systematic review. [2022]
Assessing the effectiveness of a diabetes group visit training for health center staff: a pilot study of five Midwestern community health centers. [2022]
Shared medical appointments based on the chronic care model: a quality improvement project to address the challenges of patients with diabetes with high cardiovascular risk. [2022]
Shared and individual medical appointments for children and adolescents with type 1 diabetes; differences in topics discussed? [2015]
Models of Care for Adolescents and Young Adults with Type 1 Diabetes in Transition: Shared Medical Appointments and Telemedicine. [2017]
Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security