Shared Medical Appointments for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Lily Chao, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must be taking: Type 2 diabetes medications

Disqualifiers: Non-verbal, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: 1 year

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether shared medical appointments effectively care for young people with type 2 diabetes. It aims to determine if these group sessions are acceptable and improve mental and social well-being. Participants will either attend shared appointments with group activities or receive standard care, and they will also complete surveys. Those managing type 2 diabetes with medication and receiving care at CHLA or UCSF may be suitable candidates, especially if they and their caregivers can attend group sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative care approaches that could enhance well-being for young people with type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves youth already prescribed medication for type 2 diabetes, it seems likely that you can continue your current treatment.

What prior data suggests that shared medical appointments are safe for youth with type 2 diabetes?

Research has shown that shared medical appointments (SMAs) for diabetes are generally well-received. Studies have found that these group appointments can improve the quality of care and increase patient satisfaction. For example, one study noted that SMAs helped lower blood pressure more effectively than regular care. Another study found that many patients attended SMAs regularly, indicating they found them helpful and worthwhile.

Although these studies did not specifically focus on safety, the regular attendance and positive results suggest that SMAs are unlikely to have major safety issues. Since this trial tests a new way to provide care, rather than a new drug or medical procedure, any safety risks are expected to be minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Shared Medical Appointments for Type 2 Diabetes because they offer a novel approach to managing the condition. Unlike standard care, which typically involves individual consultations with healthcare providers, this method includes group activities alongside regular clinician appointments. These group sessions provide a supportive environment where participants can learn from each other's experiences, potentially enhancing motivation and adherence to treatment plans. By fostering a community experience, Shared Medical Appointments aim to address not just the medical aspects of diabetes, but also the social and psychological facets, which are often overlooked in traditional care.

What evidence suggests that shared medical appointments are effective for type 2 diabetes?

Research has shown that shared medical appointments (SMAs), which participants in this trial may receive, can effectively manage type 2 diabetes. One study demonstrated that participants lowered their A1c levels, a measure of blood sugar control, from an average of 8.89% to 8.15% in six months. Another review found that SMAs might improve both health and behavior for people with type 2 diabetes. Additionally, group visits can reduce the emotional stress of managing diabetes. These findings suggest that SMAs could be a promising way to enhance diabetes care. ^{2 3 6 7 8}

Who Is on the Research Team?

Lily Chao, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for English-speaking youths aged 12-18 with type 2 diabetes who are on medication, and their caregivers if they speak English or Spanish. Participants must receive care at CHLA or UCSF and be willing to attend clinic visits, group sessions, and complete surveys.

Inclusion Criteria

Receives care for type 2 diabetes at either CHLA or UCSF

I am a young person who speaks English.

I am willing to go to clinic visits, join group sessions if needed, and fill out surveys.

Exclusion Criteria

Inability or unwillingness of individual to give written informed consent

Pregnancy

I am unable or unwilling to give consent for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend quarterly clinic appointments and group activities, and take surveys as part of the shared medical appointment model

1 year

4 quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shared Medical Appointments

Trial Overview

The TCT2 study is testing whether shared medical appointments are a good way to treat young people with type 2 diabetes. It compares the effectiveness of these group appointments against the usual one-on-one care by looking at how well patients accept this model and its impact on their mental health.

How Is the Trial Designed?

Group I: Shared Medical Appointment Active Control 1 Intervention

Participants will attend 4 quarterly appointments. In addition to time with their clinician, they will also have group activities that address relevant topics.

Group II: Standard Care Placebo Group 1 Intervention

Multidisciplinary team based care every 3 months.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

Shared medical appointments (SMA) for 30 male veterans with diabetes led to significant improvements in key health metrics, including A1c, blood pressure, and cholesterol levels over a 6-month period, with no hospitalizations reported.

Veteran satisfaction with the SMA approach increased significantly, highlighting its potential as an effective intervention for managing chronic conditions like diabetes in the veteran population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of Shared Medical Appointments in Veterans With Diabetes: A Quality Improvement Study. Omogbai, T., Milner, KA.[2019]

A systematic review of nine randomized trials involving various chronic illnesses (excluding diabetes and mental health) found that shared medical appointments do not negatively impact patient quality of life, knowledge, or satisfaction compared to usual care.

Patients attending shared medical appointments experienced fewer hospital admissions, suggesting potential benefits for healthcare systems, although more rigorous studies with larger sample sizes are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with a nondiabetic physical chronic illness: A systematic review. Kelly, F., Liska, C., Morash, R., et al.[2019]

Shared medical appointments (SMAs) may improve glycemic outcomes and diabetes knowledge in patients with type 2 diabetes mellitus (T2DM), based on a review of 19 studies.

However, the effectiveness of SMAs compared to standard care is still unclear due to limited studies and variability in study designs, indicating a need for larger, more standardized research to evaluate their practicality in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments May Be Effective for Improving Clinical and Behavioral Outcomes in Type 2 Diabetes: A Narrative Review. Menon, K., Mousa, A., de Courten, MP., et al.[2019]

Diabetes shared medical appointments (SMAs) significantly improved A1c levels in participants compared to usual care, with reductions of up to 0.53% for those attending at least half of the SMAs, based on a study involving 1537 adults with type 2 diabetes.

While SMAs showed immediate benefits in glycemic control, these improvements were not sustained at the 12-month follow-up, indicating a need for further research on long-term strategies to maintain these gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. Heisler, M., Burgess, J., Cass, J., et al.[2022]

Patients involved in shared medical appointments showed notable enhancements in their blood sugar levels, indicating improved glycemic control.

This approach suggests that collaborative care models may be effective in managing diabetes and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments and Their Effects on Achieving Diabetes Mellitus Goals in a Veteran Population. Tardi, A., Kapadia, S., Kurpius, M., et al.[2020]

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]

Shared medical appointments can improve education and outcomes for patients with chronic conditions, particularly among the elderly, as shown in several trials.

The effectiveness of shared medical appointments compared to traditional care remains uncertain, as it is unclear if benefits arise from the unique format or simply from increased provider interaction and time spent with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of shared medical appointments in the care of the elderly. Cherniack, EP.[2013]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8175536/

Evaluating the Effectiveness of Diabetes Shared Medical ...

05 level. The 59 P2P participants improved in A1c from a mean of 8.89% to 8.15% at 6 months and 8.25% at 12 months. All sensitivity analyses ...

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diabetesjournals.org

diabetesjournals.org/clinical/article/41/4/526/153574/A-Multi-Method-Study-of-Patient-Reach-and

A Multi-Method Study of Patient Reach and Attendance in a ...

Through this study, 22 practices reached 6.2% of patients with diabetes through SMAs over 3 years, with good attendance for both practice types ...

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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.

4.

frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2017.00263/full

Shared Medical Appointments May Be Effective for ...

Shared Medical Appointments May Be Effective for Improving Clinical and Behavioral Outcomes in Type 2 Diabetes: A Narrative Review.

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diabetes.jmir.org

diabetes.jmir.org/2025/1/e57526

Diabetes Medical Group Visits and Type 2 Diabetes Outcomes

We tested whether diabetes group medical visits (GMVs) reduced hemoglobin A 1c (HbA 1c ) by mitigating diabetes distress (DD), an emotional response affecting ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10921542/

Effectiveness of shared medical appointments delivered in ...

We found a statistically significant improvement in DBP for patients in SMAs compared with usual care, albeit a small effect size. In line with ...

7.

frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2020.570777/full

Shared Medical Appointments and Mindfulness for Type 2 ...

This study aimed to assess the feasibility and acceptability of SMAs with mindfulness for T2DM within primary care in Australia.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2464960/

Shared medical appointments based on the chronic care model

Shared medical appointments for diabetes constitute a practical system redesign that may help to improve quality of care. This approach has accommodated even ...