Virtual Care for Type 2 Diabetes

(virtual care Trial)

Recruiting at 1 trial location

Overseen By Toya Williams, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Insulin

Disqualifiers: Pregnancy, Cognitive impairment

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

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual care program designed to help people with type 2 diabetes manage their condition more effectively. The program, called Virtual Diabetes Care, employs a nurse-led approach with an app to provide education and problem-solving support. Participants will also use a diabetes app to track health data. This trial suits Medicaid recipients with type 2 diabetes who are on insulin, own a smartphone, and can use apps. As an unphased trial, it offers the opportunity to explore innovative care solutions that could enhance diabetes management.

What prior data suggests that this virtual diabetes care is safe for patients?

Research has shown that virtual diabetes care is generally safe for people with type 2 diabetes. Studies have found that virtual care can improve health outcomes, such as better blood sugar control, without causing harm. One review found that 28 out of 30 studies reported improved blood sugar levels with virtual care compared to regular care. During the pandemic, patients using telehealth also had better blood sugar control than those who only had in-person care.

Most reports suggest that virtual care is as effective as face-to-face visits for managing diabetes. It also helps reduce stress and worries about low blood sugar. This indicates that virtual care is well-tolerated and does not lead to significant negative effects. Overall, the evidence supports the safety and effectiveness of using virtual care tools to manage type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Diabetes Care because it offers a new way to manage type 2 diabetes using digital technology. Unlike standard treatments that often require frequent in-person visits, this method allows patients to access care remotely, which can improve convenience and accessibility. Additionally, the trial explores both immediate and delayed intervention models, potentially providing insights into the most effective timing for virtual interventions. This approach could lead to more personalized and flexible diabetes management, catering to individual needs and lifestyles.

What evidence suggests that this virtual diabetes care is effective for type 2 diabetes?

Research has shown that virtual care can significantly benefit people with type 2 diabetes. In this trial, participants will divide into two groups: one receiving immediate virtual diabetes care intervention and another starting the intervention three months after enrollment. One study found that 89% of participants reached their target blood sugar levels after a year of using digital tools. Another review concluded that virtual care is as effective as in-person visits for managing diabetes. Additionally, a comprehensive telehealth approach proved more successful than simpler methods for those with poorly controlled diabetes. Overall, digital tools and virtual consultations help manage blood sugar and enhance the quality of care. ^{1 6 7 8 9}

Who Is on the Research Team?

Helen NC Chen, PhD

Principal Investigator

Rutgers School of Nursing

Are You a Good Fit for This Trial?

Inclusion Criteria

My recent A1C was above 7 (if under 65) or above 8 (if 65 or older).

I am 18 years old or older.

I have type 2 diabetes.

Exclusion Criteria

Pregnancy

Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Nurse-led, app-based intervention to improve diabetes self-management, including education via MyChart, problem-solving with clinicians, and remote monitoring via mySugr app

12 months

Virtual visits at baseline, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Diabetes Care

How Is the Trial Designed?

Group I: Experimental with intervention Experimental Treatment 1 Intervention

Intervention starts at enrollment

Group II: Delayed Intervention Experimental Treatment 1 Intervention

Intervention delivery 3 months after enrollment

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11884068/

Effect of virtual care in type 2 diabetes management - PMC - NIH

This umbrella review strengthens the evidence that virtual care significantly improves clinical outcomes in people with type 2 diabetes, ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1871402125000694

a systematic review and meta-analysis of interventions

Our study demonstrates effectiveness for telemedicine-delivered interventions in preventing T2D in people at risk, specifically in people with overweight/ ...

3.

nature.com

nature.com/articles/s41598-024-76584-7

One-year outcomes of a digital twin intervention for type 2 ...

At the end of the one-year, 89.0% (1650 of 1853) of participants achieved HbA1c levels below 7%, a key target in diabetes management. 81.5% ( ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11833803/

The Impact of Virtual Consultations on Quality of Care ... - PMC

These results suggest that VC can maintain the quality of clinical outcomes in managing T2D and can be as effective as face-to-face interactions ...

5.

jmir.org

jmir.org/2025/1/e66441/

Effectiveness of Digital Diabetes Management Technology ...

Conclusions: Digital diabetes management has been shown to effectively improve blood glucose levels and BMI in individuals with T2DM in home ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666142X2300053X

Effectiveness of telehealth on the glycemic control ...

This study aimed to examine the impact of telehealth on the glycemic control of individuals with type 2 diabetes mellitus during the pandemic.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10899831/

Telehealth Technologies in Diabetes Self-management and ...

Efficacy of diabetes app use has been evaluated in several studies by demonstrating improvement in health-related outcomes, such as lower hemoglobin A1C, ...

8.

diabetesjournals.org

diabetesjournals.org/spectrum/article/35/1/33/144543/Challenges-and-Opportunities-in-Using-Telehealth

Challenges and Opportunities in Using Telehealth for ...

We examine new opportunities and ongoing challenges for using telehealth within diabetes management, based on data and experiences from the pre-pandemic and ...

9.

researchgate.net

researchgate.net/publication/389632198_Effect_of_virtual_care_in_type_2_diabetes_management_-_a_systematic_umbrella_review_of_systematic_reviews_and_meta-analysis

(PDF) Effect of virtual care in type 2 diabetes management

Of the 30 reviews, 28 reported that virtual care improved HbA1c compared to usual care. Meta-analysis of 16 reviews revealed a mean difference of -0.37% (-0.41% ...