Virtual Group Visits for Type 2 Diabetes

(VIDA Trial)

Recruiting at 1 trial location

Overseen By Danielle Lazar

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Disqualifiers: Type 1 diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

720 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is it safe to participate in virtual group visits for diabetes management?

The available research on virtual group visits for diabetes management does not report any specific safety concerns. These visits are generally considered safe, as they involve education and support rather than direct medical interventions. ^{1 2 3 4 5}

How is the Virtual Group Visit treatment for type 2 diabetes different from other treatments?

Virtual Group Visits for type 2 diabetes are unique because they combine group education and individual medical consultations in a virtual setting, providing patients with social support and frequent contact with healthcare providers. This approach is different from traditional treatments as it leverages telehealth to improve patient engagement, diabetes knowledge, and emotional support, especially beneficial for those with limited access to in-person care. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment Virtual Group Visits for Type 2 Diabetes?

Research shows that virtual group visits for diabetes can help lower blood sugar levels, especially in patients with higher initial levels, and increase diabetes knowledge and support. These visits also reduce stress related to diabetes and empower patients to manage their condition better. ^{1 4 5 9 10}

Who Is on the Research Team?

Arshiya Baig, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 2 diabetes and an A1C level above 8%, who also have a cardiovascular condition like high blood pressure, heart disease, or obesity. Participants must be from certain clinics, speak English or Spanish, and their primary care doctor must agree to their involvement.

Inclusion Criteria

I visited a participating clinic in the last year.

Patient must have Type 2 diabetes

Patient must have A1C greater than 8% within 6 months prior to the first study visit (recruitment priority: A1C>9%, then A1C>8.5%, then A1C>8%)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff

6 months

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Group Visit

Trial Overview The study is testing the effectiveness of virtual group visits as a treatment method for patients with type 2 diabetes. It aims to see if these online meetings can help manage diabetes better than traditional methods.

How Is the Trial Designed?

Group I: Virtual Group Visit Arm Experimental Treatment 1 Intervention

These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.

Group II: Usual Care Arm Active Control 1 Intervention

These subjects will receive usual diabetes care at ACCESS or Advocate health centers.

Virtual Group Visit is already approved in United States for the following indications:

Approved in United States as Virtual Diabetes Group Visits for:

• Type 2 Diabetes Mellitus (T2DM)

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

ACCESS Community Health Network

Collaborator

Trials

7

Recruited

62,700+

Advocate Health Care

Collaborator

Trials

57

Recruited

1,412,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Midwest Clinicians' Network

Collaborator

Trials

3

Recruited

2,200+

Published Research Related to This Trial

In a study involving 53 young adults with type 1 diabetes, those who participated in virtual group appointments (VGA) reported significantly reduced diabetes distress compared to those who only received telehealth services, indicating that VGA can enhance emotional well-being.

Participants in the CoYoT1 Clinic with VGA also showed improvements in self-management skills and communication with healthcare providers, suggesting that this approach may foster better diabetes care and support among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Group Appointments Reduce Distress and Improve Care Management in Young Adults with Type 1 Diabetes. Bisno, DI., Reid, MW., Fogel, JL., et al.[2022]

A pilot study involving 34 patients at five community health centers showed that virtual diabetes group visits (GVs) can lead to significant improvements in diabetes knowledge and support, as well as a reduction in diabetes distress.

While there was a nonsignificant overall decrease in A1C levels, patients with a baseline A1C of 9% or higher experienced a significant reduction, suggesting that virtual GVs may be particularly beneficial for those with more severe diabetes management challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Effects of Virtual Diabetes Group Visits in Community Health Centers During the COVID-19 Pandemic. Dinh, T., Staab, EM., Nuñez, D., et al.[2023]

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]

A 5-year study involving 48 adults with type 2 diabetes mellitus (T2DM) demonstrated that virtual diabetes group visits (GVs) can improve patient engagement and self-management, with 71% of participants attending at least one session.

Staff reported that virtual GVs fostered better relationships with patients and enhanced team collaboration, although challenges such as technology access and patient recruitment were noted, highlighting the need for support in implementing these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting in-person diabetes group visits to a virtual setting across federally qualified health centers. Nuñez, D., Marino-Nuñez, D., Staab, EM., et al.[2023]

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]

Virtual group visits (VGVs) are emerging as a promising approach for health promotion and chronic disease management, adapted from the shared medical appointment model.

To establish VGVs as a standard care practice, further evidence is needed regarding their clinical effectiveness, financial sustainability, and accessibility for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Group Visits: Hope for Improving Chronic Disease Management in Primary Care During and After the COVID-19 Pandemic. Mirsky, JB., Thorndike, AN.[2021]

In a study comparing Diabetes Group Medical Visits (DGMVs) to usual care among 111 low-income patients with diabetes, those attending DGMVs showed a significant decrease in systolic blood pressure, indicating some effectiveness of group visits in managing certain health metrics.

However, the overall impact on health outcomes was limited, likely due to low attendance, as most participants attended three or fewer DGMVs in a year, suggesting that more frequent participation may be necessary for better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes group medical visits and outcomes of care in low-income, rural, uninsured persons. Mallow, JA., Theeke, LA., Whetsel, T., et al.[2020]

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]

In a study involving 230 participants in group medical visits (GMVs) for type 2 diabetes management, attendees averaged only one session, indicating low engagement with the program.

The evaluation found no significant differences in clinical outcomes, care processes, or healthcare utilization between GMV participants and a matched comparison group, suggesting that the GMV model may not be effective in improving diabetes management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Ongoing Diabetes Group Medical Visit in a Family Medicine Practice. Cunningham, AT., Delgado, DJ., Jackson, JD., et al.[2022]

In a 12-month study involving 186 diabetic patients, group visits significantly improved adherence to American Diabetes Association guidelines and increased cancer screening rates compared to traditional care, with breast and cervical cancer screening rates rising to 80%.

However, there were no significant differences in clinical outcomes like HbA1c, blood pressure, and lipid levels between patients in group visits and those receiving usual care, suggesting that while group visits enhance care quality, they may need adjustments to improve clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group visits: promoting adherence to diabetes guidelines. Clancy, DE., Huang, P., Okonofua, E., et al.[2022]

Citations

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

Virtual Group Appointments Reduce Distress and Improve Care Management in Young Adults with Type 1 Diabetes. [2022]

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

Evaluating Effects of Virtual Diabetes Group Visits in Community Health Centers During the COVID-19 Pandemic. [2023]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Adapting in-person diabetes group visits to a virtual setting across federally qualified health centers. [2023]

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

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

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

Virtual Group Visits: Hope for Improving Chronic Disease Management in Primary Care During and After the COVID-19 Pandemic. [2021]

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

Diabetes group medical visits and outcomes of care in low-income, rural, uninsured persons. [2020]

8. 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]

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

Evaluation of an Ongoing Diabetes Group Medical Visit in a Family Medicine Practice. [2022]

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

Group visits: promoting adherence to diabetes guidelines. [2022]