Technology-Enabled Nursing for Type 2 Diabetes and High Blood Pressure

(EXTEND Trial)

Overseen By Gina N Pennington, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Glucose-lowering, Blood pressure-lowering

Disqualifiers: Dementia, Psychosis, Life-limiting illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mobile devices and nursing support can help people manage type 2 diabetes and high blood pressure more effectively. Participants will use devices like a glucometer and blood pressure cuff to monitor their health at home. Nurses will review the data and adjust medication as needed. This trial suits individuals with uncontrolled type 2 diabetes (consistently high blood sugar levels) and high blood pressure who use a smartphone and can communicate in English. As an unphased trial, it offers a unique opportunity to contribute to innovative healthcare solutions and enhance personal health management.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves monitoring diabetes and hypertension, it's likely you will continue your current treatment.

What prior data suggests that these mobile monitoring devices and nursing support are safe for managing diabetes and hypertension?

Research has shown that using mobile devices to manage diabetes and high blood pressure is generally safe. Similar studies have demonstrated that these tools help people track their health and make necessary changes with few issues. Major reports of problems or side effects from using these devices have not emerged.

In this trial, the EXTEND Plus and EXTEND treatments include tools such as a glucometer (to check blood sugar), a blood pressure cuff, a scale, and an accelerometer (to track movement). These tools are commonly used in everyday health monitoring. Users typically find them easy to use, aiding in the management of long-term conditions like diabetes and high blood pressure.

While specific data from past studies on EXTEND or EXTEND Plus is limited, the use of these monitoring tools is widely accepted in medical settings, suggesting they are safe and well-tolerated. Additionally, the involvement of registered nurses and pharmacists in the EXTEND Plus treatment should help address any issues promptly, adding another layer of safety.

Overall, using these devices with support from healthcare professionals can help manage health without significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EXTEND and EXTEND Plus treatments for type 2 diabetes and high blood pressure because they integrate technology into chronic disease management in a unique way. Unlike traditional treatments that rely mainly on medication and periodic doctor visits, these methods use four mobile monitoring devices—like a glucometer and BP cuff—to provide real-time health data. This data is shared with Duke University Health System, allowing registered nurses to deliver personalized care and medication management remotely. EXTEND Plus goes a step further by involving clinical pharmacists in the medication management process, adding another layer of tailored support. This tech-enabled approach aims to empower patients to take control of their health more actively and conveniently, potentially improving outcomes and reducing the burden on healthcare systems.

What evidence suggests that these mobile monitoring devices and nursing support are effective for managing type 2 diabetes and high blood pressure?

Research has shown that maintaining blood pressure below 120 mmHg in individuals with both type 2 diabetes and high blood pressure can reduce the risk of heart-related deaths and strokes by 25%. Studies also indicate that having both high blood pressure and diabetes doubles the risk of dying from any cause compared to having diabetes alone. Keeping blood pressure under 140 mmHg can significantly lower the risk of heart issues in those with diabetes. In this trial, participants in the EXTEND and EXTEND Plus arms will use mobile devices to track these health measures. The EXTEND Plus arm will also receive nurse support, combining mobile monitoring with self-management support and medication management. These technology-based methods aim to simplify and enhance the management of these conditions. ^{1 4 5 6 7}

Who Is on the Research Team?

Ryan J Shaw, RN, PhD

Principal Investigator

Duke University School of Nursing

Matthew Crowley, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults with uncontrolled high blood pressure and type 2 diabetes, who have had poor management of these conditions over the past year. Participants must be able to give informed consent, speak English, use a smartphone, and have been seen at the primary clinic site in the last year. Pregnant individuals or those living in nursing homes are not eligible.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

I have been diagnosed with high blood pressure or am on medication for it.

My blood pressure has been above 140/90 in the past year.

Exclusion Criteria

Unable or unwilling to use necessary technology to participate in study

I had a heart attack or similar heart issue in the last year.

You live in a nursing home.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mobile monitoring devices and nursing support for chronic disease self-management

12 months

Initial encounters every two weeks, extended to every four weeks upon achieving treatment goals

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EXTEND
• EXTEND-Monitoring
• EXTEND-Nursing
• EXTEND Plus

Trial Overview

The study is testing two programs: EXTEND and EXTEND Plus. Both involve using mobile devices for monitoring health and receiving nurse support to see if they help patients better manage their diabetes and hypertension on their own.

How Is the Trial Designed?

Group I: EXTEND Plus Experimental Treatment 1 Intervention

EXTEND Plus participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS) for use as part of nurse-delivered intervention combining mobile monitoring, self-management support, and medication management. The intervention is administered by clinical registered nurses (RNs) from Duke Primary Care (DPC) or Duke Endocrinology. For the medication management component, RNs work with a study PharmD affiliated with the participant's clinic. The PharmD determines if medication changes are needed, and prescribes accordingly. The RNs deliver EXTEND Plus via scheduled telephone encounters throughout the 12-month intervention. The initial encounter frequency is every two weeks, but may be extended to every four weeks for patients achieving treatment goals.

Group II: EXTEND Active Control 1 Intervention

EXTEND participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS). Participants can review data and trends within the device apps and modify self-management practices accordingly. The EXTEND group continues chronic disease care with their existing providers during the study, and are instructed at baseline to address management questions via their primary clinics' established avenues (as would be the case for any patient using mobile monitoring in clinical practice).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Nurse-led telephone counseling significantly improved health behaviors and self-care for hypertension in low-income older adults, with a medium effect size (Cohen's d = 1.16) after 8 weeks.

The intervention also led to a reduction in systolic blood pressure (Cohen's d = -0.61), suggesting that personalized support can enhance health outcomes in disadvantaged populations using telemonitoring systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone Support and Telemonitoring for Low-Income Older Adults. Jeong, S., Choi, H., Gwon, SH., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12112238/

Pillars of Blood Pressure Management in Patients with Type 2 ...

This five-pillar approach offers a comprehensive and evolving perspective on BP management in patients with T2DM, although certain aspects continue to be ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9224227/

Hypertension and Type 2 Diabetes—The Novel Treatment ...

After 9 years of intensive blood pressure control (systolic BP < 120 mmHg), a 25% reduction in composite cardiovascular death, nonfatal stroke ...

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patientcareonline.com

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Coexisting Hypertension and Type 2 Diabetes in US Adults ...

Compared to having T2D alone, having coexisting T2D and HTN was associated with a 25% higher risk of dying from any cause and more than double ...

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explorationpub.com

explorationpub.com/Journals/eemd/Article/101422

A brief approach to hypertension in type 2 diabetes mellitus

According to another meta-analysis, for achieved SBP of < 140 mmHg, most CVS outcomes were significantly more reduced in diabetic patients compared to ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1751991823001663

A systematic review and meta-analysis of 45 cohort studies

In diabetes, SBP ≥ 140 versus < 140 mmHg is associated with an increased risk of composite cardiovascular outcomes. •. SBP ≥ 140 versus < 140 mmHg is ...

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healio.com

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Concurrent type 2 diabetes, hypertension more than ...

Adults with both prediabetes and elevated BP had a 10% higher all-cause mortality risk and a 19% greater CV mortality risk than adults with ...

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Hypertension and Diabetes Mellitus

Elevated blood pressure (BP) values are a common finding in patients with type 2 diabetes mellitus (T2D) and are thought to reflect, at least in ...