Digital Health Platform for Type 2 Diabetes

(GUIDE Trial)

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Overseen BySoohyun Nam, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an Integrated Digital Health (IDH) platform to help manage Type 2 diabetes. The researchers aim to determine if using the platform, with or without healthcare provider assistance, improves blood sugar control and other diabetes-related outcomes. The trial also explores how to integrate this platform into regular primary care. Participants should have had Type 2 diabetes for at least one year, a recent HbA1c blood sugar level between 8-11%, and own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care solutions.

What prior data suggests that this digital health platform is safe for adults with Type 2 diabetes?

Research has shown that the Integrated Digital Health (IDH) platform is generally safe for people with type 2 diabetes. Studies have found that digital health tools can improve blood sugar control and aid in weight loss. For instance, one study reported that users of digital health platforms lost 6.2% of their weight over six months, indicating that the platform is well-tolerated, with no major side effects reported.

Another study demonstrated that these digital tools effectively manage diabetes, helping users improve their blood sugar levels and overall health. This suggests that the IDH platform is safe for managing type 2 diabetes, with or without a healthcare provider's involvement. Overall, existing research supports the safety of digital health tools like the IDH platform, making them a promising option for managing diabetes.12345

Why are researchers excited about this trial?

Researchers are excited about the Integrated Digital Health (IDH) platform for type 2 diabetes because it offers a fresh approach to managing the condition. Unlike traditional treatments that often rely solely on medication and periodic glucose monitoring, the IDH platform integrates continuous digital monitoring with real-time data analysis. This setup can provide personalized feedback and support, potentially improving patient engagement and self-management. Additionally, the IDH platform with provider engagement takes it a step further by facilitating direct communication between patients and healthcare providers, allowing for timely adjustments in treatment plans. These features could lead to more precise and responsive diabetes management compared to the current standard of care.

What evidence suggests that this trial's treatments could be effective for Type 2 diabetes?

Research has shown that digital health tools can effectively manage Type 2 diabetes. In this trial, participants will divide into different groups to evaluate these tools' effectiveness. Group A will use Continuous Glucose Monitoring (CGM) only. Group B will use the Integrated Digital Health (IDH) platform without provider engagement, while Group C will use the IDH platform with provider engagement. Studies have found that digital tools can lead to better blood sugar control without increasing the risk of severe low blood sugar. Specifically, one study found that patients using digital tools experienced significant improvements in blood sugar levels and overall health. Another study showed that involving healthcare providers in these digital platforms can further enhance diabetes management. This evidence suggests that digital health tools, combined with support from healthcare providers, can improve diabetes outcomes.678910

Who Is on the Research Team?

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Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN

Principal Investigator

Yale University School of Nursing

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 diabetes. Participants should be able to use digital health tools and are likely receiving care in a primary care setting. Specific inclusion or exclusion details were not provided.

Inclusion Criteria

Recent 3 month-HbA1c between 8-11%
Ownership of a smartphone
I have had type 2 diabetes for at least one year.
See 1 more

Exclusion Criteria

Pregnant
I am not able or willing to use a continuous glucose monitor or the study device.
Serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline visit
1 visit (in-person)

Treatment

Participants engage with the Integrated Digital Health (IDH) intervention, with or without healthcare provider engagement, to improve glycemic control and diabetes-related outcomes

16 weeks
Ongoing engagement with digital health tools and potential telehealth visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks
2 follow-up visits (in-person) at 16 weeks and 32 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Digital Health (IDH) platform
  • Provider engagement

Trial Overview

The study is testing an Integrated Digital Health (IDH) platform, both alone and combined with extra support from healthcare providers, to see if it helps people manage their blood sugar better compared to usual care.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Group C: Integrated Digital Health (IDH) platform with provider engagementExperimental Treatment2 Interventions
Group II: Group B: Integrated Digital Health (IDH) platform without provider engagementExperimental Treatment1 Intervention
Group III: Group A: Continuous Glucose Monitoring (CGM)-onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Glucose, Understanding, Integrated Digital... | Clinical Trial

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Clinical outcomes of a digitally delivered structured lifestyle ...

This digitally delivered lifestyle intervention program produced clinically meaningful improvements in glycemic control, anthropometric measures, and diabetes ...

Clinical Effects of a Digital Health Intervention for Adults ...

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(PDF) Validation of the effectiveness of a digital integrated ...

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Project Grant R01DK149276

The award funds a three-arm randomized controlled trial enrolling 300 adults with type 2 diabetes to assess a unified digital health ...

48-Week Results From a Randomized Controlled Trial.

We investigated the efficacy of an integrated digital health care platform with artificial intelligence (AI)-based dietary management in adults ...

Digital Health Solutions for Type 2 Diabetes and Prediabetes

This systematic review provides important insights into the design and implementation of digital health interventions for T2DM and prediabetes management, ...

The effects of mobile health on self-management of patients ...

A novel mobile health (mHealth) intervention intends to assist diabetics in managing the levels of their blood sugar and improving self-care.

1469-P: Real-World Weight Loss with Digital Health with and ...

22.7% had type 2 diabetes based on diagnostic claims. Digital health alone resulted in clinically meaningful weight loss (-6.2% at 6 months; -6 ...

Digital diabetes platform improves outcomes and lowers costs

A digital self-management platform for people with type 2 diabetes has been associated with improved clinical outcomes and could reduce long- ...