Group Visits for Type 1 Diabetes

Not currently recruiting at 1 trial location

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

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 5 6}

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

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]

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 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]

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 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 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]

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) 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3915887/

Shared medical appointments for children and adolescents ...

This study examined the perspectives and experiences of patients, parents, and health care providers with shared medical appointments (SMAs) for children ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03590041

Comparative Effectiveness of Diabetes Shared Medical ...

In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs.

3.

diabetesincontrol.com

diabetesincontrol.com/wp-content/uploads/PDF/dcms25_intro_sma_pt1.pdf

UNDERSTANDING SHARED MEDICAL APPOINTMENTS

DIGMA and Physicals SMA models, studies have tracked the positive impact of group visits on physicians' productivity45 and on access.45 Preliminary data on the.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05431686

Group Visits for High Risk Type 1 Diabetes (T1D) | ...

The investigators propose to conduct a pilot prospective cohort study to assess the impact of shared medical appointments (SMA) visits in underserved youth ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7781059/

Lifestyle Medicine Shared Medical Appointments - PMC

This article offers a brief history of group visits and shared medical appointments and reviews the available data regarding their outcomes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4284267/

Shared Medical Appointments for Patients with Diabetes ...

We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes.