5000 Participants NeededMy employer runs this trial

Digital Health Coaching + Continuous Glucose Monitoring for Type 2 Diabetes

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Overseen ByRebecca Rogers, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
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?

The trial aims to identify the most effective telehealth approach for managing type 2 diabetes and other chronic conditions in individuals with physical disabilities. Participants will receive either digital health coaching, continuous glucose monitoring (CGM) with clinician support, or a combination of both. The researchers seek to determine which method best lowers blood sugar levels, reduces diabetes-related stress, and improves overall health. This trial suits individuals with type 2 diabetes, a physical disability, and at least one other chronic condition, such as high blood pressure or asthma. As an unphased trial, it offers a unique opportunity to explore innovative telehealth solutions that could significantly enhance health management.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found continuous glucose monitoring (CGM) devices easy for users to handle. These devices send blood sugar information to healthcare providers, enabling remote diabetes monitoring. Many users expressed high satisfaction with CGM, giving it positive reviews. This feedback suggests that CGM is generally safe and easy to use.

Digital health coaching, which provides personalized support for lifestyle changes, is also considered safe. It focuses on improving habits related to diet and exercise, which are generally safe activities.

Both methods aim to help people with type 2 diabetes manage their condition. Current research shows that these approaches are not only effective but also safe for most participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines digital health coaching with continuous glucose monitoring (CGM) teleconsults, offering a personalized approach to managing Type 2 diabetes. Unlike standard treatments that often rely on medication and periodic doctor visits, this approach provides ongoing support and real-time data tracking. Digital health coaching helps individuals set and achieve lifestyle goals through regular phone check-ins, while CGM teleconsults allow healthcare providers to tailor treatments based on detailed glucose patterns. This integrated method could lead to better understanding and management of individual glucose levels, potentially improving overall health outcomes for those with Type 2 diabetes.

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

This trial will evaluate the effectiveness of different approaches for managing type 2 diabetes. Participants in one arm will receive digital health coaching, which research has shown can lower A1C levels by an average of 0.32%. One study found that digital coaching improved A1C levels by 13% and reduced diabetes-related stress by 22%. In another arm, participants will use continuous glucose monitoring (CGM) with online consultations. Studies have shown that CGM can lower A1C levels by 0.42% and help maintain blood sugar levels within the target range. A third arm will combine digital coaching with CGM, and evidence suggests even better blood sugar control, with A1C reductions between 0.4% and 1.5%. Together, these methods may offer a comprehensive way to manage type 2 diabetes effectively.678910

Who Is on the Research Team?

TM

Tapan Mehta, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults with a physical disability, diagnosed with type 2 diabetes, whose recent average blood sugar (A1c) is 8% or higher. Participants must also have at least one other chronic health condition like high blood pressure, heart disease, arthritis, asthma, cancer, kidney disease (not on dialysis), COPD, osteoporosis, multiple sclerosis or Parkinson's.

Inclusion Criteria

Must have at least 1 additional chronic condition from the following: Hypertension, Congestive Heart Failure, Coronary Artery Disease, Hyperlipidemia, Stroke, Arthritis, Asthma, Cancer, Chronic Kidney Disease (Stages 1-4), COPD, Osteoporosis, Multiple Sclerosis, Parkinsons
Physical Disability
Hemoglobin A1c ≥7% within 3 months of screening
See 1 more

Exclusion Criteria

Non-english speakers
Currently pregnant
Intellectual, Learning, Developmental Disabilities
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Health Coaching

Participants receive individual digital health coaching by phone: weekly calls for the first 12 weeks addressing goal setting, supportive environments for behavior change, physical activity, and nutrition, followed by biweekly calls for an additional 12 weeks to reinforce habits and advance goals.

24 weeks
Weekly calls for 12 weeks, biweekly calls for 12 weeks

Continuous Glucose Monitoring Teleconsults

Participants receive continuous glucose monitoring with periodic clinician teleconsults over 6 months. Study staff ship a CGM kit to the participant's home; sensors are replaced per manufacturer guidelines. During each teleconsult, the primary care team reviews glucose data and adjusts goals or medications as needed.

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on long-term outcomes such as changes in Hemoglobin A1c and diabetes distress.

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Glucose Monitoring Teleconsults
  • Digital Health Coaching

Trial Overview

The study compares two telehealth approaches: digital health coaching and remote glucose monitoring via online consultations. Some participants may receive both interventions together. The goal is to see which method better helps people manage their diabetes and overall health.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Digital Health CoachingExperimental Treatment1 Intervention
Group II: Continuous Glucose Monitoring TeleconsultsExperimental Treatment1 Intervention
Group III: Combination of Digital Health Coaching and CGM-TeleconsultsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

Outcomes of Diabetes Management with Continuous ...

CGM use was consistently associated with improvements in glycemic control, with HbA1c reductions ranging from approximately 0.4% to 1.5% across studies, and the ...

Health Coaching for Diabetes Patients

Digital Health Intervention for Self-Management in Type 2 Diabetes. Intervention to Improve Diabetes-Related Outcomes in Chinese Americans With Type 2 Diabetes ...

Gamified Optimized Diabetes Management With Artificial ...

digital health coaching has been shown to be effective in improving T2DM outcomes, particularly lowering HbA1c. A systematic review and meta- ...

Combining Flash Glucose Monitoring and Online Peer ...

These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.

2020 Study on Digital Health: Diabetes Apps and Virtual ...

These technologies are engaging and empowering patients, improving glycemic control, and lowering complications. Digital health technologies are ...

Continuous Glucose Monitoring and Telehealth Integration ...

CGM devices automatically transmit glucose data to cloud-based platforms, allowing healthcare providers to monitor patients remotely. This integration enables:.

The impact of telehealth remote patient monitoring on ...

Conclusion: Current evidence suggests that telehealth is effective in controlling HbA1c levels in people living with type 2 diabetes. However ...

Telehealth Technologies and Their Benefits to People With ...

Even for people with diabetes who lack internet access or a smartphone, a CGM system's receiver can provide data they can report to their HCP ...

Remote diabetes management using CGM and ...

New case studies show the benefits of remote management based on continuous glucose monitoring (CGM) and telemedicine visits for patients ...

High User Satisfaction Rates with DEXCOM™ Continuous ...

DCGM was associated with good levels of glucose monitoring satisfaction with an overall satisfaction score of 3.67 ± 1.24 out of 5. Participants ...