What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include lifestyle interventions, metformin, sulphonylureas, insulin, and GLP-1 receptor agonists. Lifestyle interventions, such as diet and exercise, generally have minimal side effects but can be challenging to maintain. Metformin is usually well-tolerated but can cause gastrointestinal issues like nausea and diarrhea. Sulphonylureas may lead to hypoglycemia and weight gain. Insulin therapy, while effective, carries risks of hypoglycemia and potential cardiovascular issues. GLP-1 receptor agonists can cause gastrointestinal side effects, including nausea and vomiting. Mobile monitoring devices and nursing support aim to enhance these treatments by providing real-time health tracking and professional guidance, potentially improving adherence and outcomes.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes, including GLP-1 agonists like liraglutide and extended-release exenatide, which are effective in improving glycemic control and have been approved for use in children aged 10 and older. Liraglutide, for instance, was approved based on the ELLIPSE trial, which demonstrated significant improvements in hemoglobin A1c levels and blood lipid profiles. Extended-release exenatide was approved following a trial that showed improved glycemic control and modest weight loss. These treatments, along with the use of mobile monitoring devices and nursing support, represent a comprehensive approach to managing Type 2 Diabetes by combining pharmacologic intervention with real-time health tracking and professional guidance.

What other types of research exist?

Promising alternatives for Type 2 Diabetes management in 2024 include: 1) Continuous Glucose Monitoring (CGM) systems integrated with decision support smartphone applications, which provide real-time data and personalized recommendations. 2) Telemedicine platforms offering remote consultations and continuous support from healthcare providers. 3) Algorithm-driven insulin pumps (Hybrid Closed-Loop systems) that automatically adjust insulin delivery based on real-time glucose readings. 4) Digital health coaching programs that use AI to offer personalized lifestyle and medication management advice.

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Behavioral Intervention

Technology-Enabled Nursing for Type 2 Diabetes and High Blood Pressure (EXTEND Trial)

N/A

Waitlist Available

Led By Ryan J Shaw, RN, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of type 2 diabetes by International Classification of Diseases (ICD) code or treatment with glucose-lowering medication or mention in clinical notes

Diagnosis of hypertension by ICD code or treatment with blood pressure-lowering medication or mention in clinical notes

Must not have

Acute coronary event in past year

Diagnosis of dementia, psychosis, or life-limiting illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 9, 12, 18 and 24 months

Awards & highlights

Summary

This trial investigates if using mobile devices to monitor health and getting support from nurses can help people with poorly controlled diabetes and high blood pressure who haven't improved with regular treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves technology use and nurse support rather than medication, traditional side effects are not applicable. However, participants may experience issues related to technology use such as privacy concerns or stress from constant health monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 2 diabetes.

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

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

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My diabetes control is poor, with my HbA1c always above 8.0% in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with dementia, psychosis, or a terminal illness.

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I have had a seizure or coma due to low blood sugar in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 9, 12, 18 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 9, 12, 18 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9, 12, 18 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c

Secondary study objectives

Change in Diabetes Self-Management Questionnaire

Change in Perceived Competence Scale

Change in blood pressure

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EXTEND PlusExperimental Treatment1 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: EXTENDActive Control1 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).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 2 Diabetes include metformin, sulfonylureas, insulin, SGLT2 inhibitors, and GLP-1 receptor agonists. Metformin works by reducing glucose production in the liver and improving insulin sensitivity. Sulfonylureas increase insulin secretion from the pancreas. Insulin therapy directly supplements the body's insulin levels. SGLT2 inhibitors prevent glucose reabsorption in the kidneys, leading to glucose excretion in urine. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. These mechanisms are crucial for Type 2 Diabetes patients as they help manage blood glucose levels, reduce complications, and improve overall health. Real-time health tracking and professional guidance can optimize these treatments by providing timely adjustments and personalized care, enhancing their effectiveness and patient outcomes.

A Systematic Review of Collective Evidences Investigating the Effect of Diabetes Monitoring Systems and Their Application in Health Care.