Group Visits for Type 1 Diabetes

Overseen By Brynn Marks, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Must be taking: Insulin

Must not be taking: Non-insulin diabetes

Disqualifiers: Insulin pump, Major illnesses, others

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

Compensation: Varies

Number of Visits: 7

20 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{1 2 3 4 8}

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

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: SMA visit intervention arm Experimental Treatment 1 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

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

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

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with diabetes mellitus: a systematic review. Edelman, D., Gierisch, JM., McDuffie, JR., et al.[2022]

The pilot study involving 26 community health center staff across five Midwestern states showed that participants had a strong initial understanding of diabetes group visit implementation, but their attitudes and practices improved regarding billing and awareness of barriers.

Key factors for successful implementation included access to resources, motivated teams, and supportive leadership, while challenges included patient socioeconomic issues, staff time constraints, and turnover.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the effectiveness of a diabetes group visit training for health center staff: a pilot study of five Midwestern community health centers. Barnes, PA., Barouhas, I., Staab, EM., et al.[2022]

Shared Medical Appointments (SMAs) for diabetes management led to significant reductions in key health markers: A1c levels decreased by an average of 1.4%, LDL-cholesterol by 14.8 mg/dl, and systolic blood pressure by 16.0 mm Hg, indicating improved cardiovascular risk.

Patients participating in SMAs showed greater improvements in A1c and systolic blood pressure compared to a control group, suggesting that this group-based approach can enhance the quality of care for high-risk diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kirsh, S., Watts, S., Pascuzzi, K., et al.[2022]

Shared medical appointments (SMAs) for children and adolescents with type 1 diabetes cover more diabetes-related topics compared to traditional individual outpatient visits, enhancing the breadth of information shared.

Participants in SMAs reported a more equal distribution of conversational contributions and valued learning from each other's questions, indicating that SMAs may improve patient engagement and support in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared and individual medical appointments for children and adolescents with type 1 diabetes; differences in topics discussed? Rijswijk, C., Zantinge, E., Seesing, F., et al.[2015]

Adolescents and young adults with type 1 diabetes face significant challenges in managing their condition, leading to poor glycemic control and increased complications, highlighting the need for better care strategies.

Innovative clinical models like telemedicine and shared medical appointments (SMA) are proposed as effective ways to engage this age group in their diabetes care, potentially improving their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of Care for Adolescents and Young Adults with Type 1 Diabetes in Transition: Shared Medical Appointments and Telemedicine. Raymond, JK.[2017]

The study aims to develop and test a shared medical appointment (SMA) model specifically for adolescents and young adults with Type 1 Diabetes (T1D), addressing their unique challenges in glycemic control.

A randomized clinical trial will evaluate the feasibility and preliminary efficacy of this intervention toolkit, focusing on both provider satisfaction and patient outcomes, including diabetes management and family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes. Salvy, SJ., Ruelas, V., Majidi, S., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Shared medical appointments and patient-centered experience: a mixed-methods systematic review. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial. [2022]

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

Shared medical appointments for patients with diabetes mellitus: a systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Assessing the effectiveness of a diabetes group visit training for health center staff: a pilot study of five Midwestern community health centers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. Ireland pubmed.ncbi.nlm.nih.gov

Shared and individual medical appointments for children and adolescents with type 1 diabetes; differences in topics discussed? [2015]

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

Models of Care for Adolescents and Young Adults with Type 1 Diabetes in Transition: Shared Medical Appointments and Telemedicine. [2017]

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

Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes. [2021]