What side effects are associated with this type of intervention?

Common treatments for blood sugar control include lifestyle interventions, metformin, sulfonylureas, insulin, GLP-1 receptor agonists, and SGLT2 inhibitors. Lifestyle interventions generally have minimal side effects but may include fatigue and muscle soreness. Metformin is often associated with gastrointestinal issues such as diarrhea and nausea. Sulfonylureas can cause hypoglycemia and weight gain. Insulin therapy also carries a risk of hypoglycemia and potential weight gain. GLP-1 receptor agonists may cause gastrointestinal symptoms like nausea and vomiting, while SGLT2 inhibitors can lead to urinary tract infections and genital infections.

What prior FDA approvals exist?

The FDA has approved several drugs for blood sugar control in type 2 diabetes that align with patient-centered, team-based care models. Notable approvals include metformin, which is often used as a first-line treatment, and GLP-1 agonists like liraglutide and extended-release exenatide, which have shown efficacy in improving glycemic control and are approved for use in both adults and children. These medications are often integrated into comprehensive care plans that include lifestyle interventions and behavioral support, similar to the approach studied in the LUNA-E trial, which combines medical and behavioral care with E-Health enhancements to improve glycemic control and reduce psychological distress.

What other types of research exist?

Promising alternatives for blood sugar control in 2024 include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in sleep-related quality of life and insomnia symptoms, potentially benefiting overall diabetes management. 2) Hybrid Closed-Loop (HCL) insulin delivery systems, which automatically adjust insulin delivery based on continuous glucose monitoring, improving glycemic outcomes and quality of life. 3) Telemedicine interventions, which have demonstrated modest reductions in A1C levels and can enhance patient engagement and adherence through remote monitoring and virtual consultations.

← Back to Search

E-Health Intervention for Type 2 Diabetes (LUNA-E Trial)

N/A

Recruiting

Led By Gregory A Talavera, MD/MPH

Research Sponsored by San Diego State University

Eligibility Criteria Checklist

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

Must have

Type 2 diabetes with hemoglobin A1C (HbA1c) >8% in past 90 days

18 years of age or older

Must not have

Actively being treated for cancer or Parkinson's Disease

Have severe diabetes complications (e.g., renal disease, or on dialysis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a team-based healthcare approach with online tools to help Latino patients with type 2 diabetes manage their condition. The goal is to improve blood sugar control and reduce stress and anxiety related to diabetes.

Who is the study for?

This trial is for Hispanic/Latino adults with Type 2 diabetes and poor blood sugar control (HbA1c >8%). Participants must be registered at a qualifying health center, not in other diabetes programs, and have their doctor's approval. Exclusions include severe diabetes complications, current cancer or Parkinson's treatment, plans to move soon, severe health issues preventing consent, or being pregnant/nursing.

What is being tested?

The LUNA-E study is testing a patient-centered care approach using virtual visits, coordinated care management, integrated medical and behavioral support alongside educational videos. This randomized trial aims to improve blood sugar levels and reduce psychological distress among participants.

What are the potential side effects?

Since the interventions involve non-medical treatments like e-health services and education rather than drugs or invasive procedures, side effects are minimal but may include discomfort from increased attention to health status or anxiety about technology use.

Eligibility Criteria

Inclusion Criteria

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

Select...

My last HbA1c level was over 8%.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I am currently receiving treatment for cancer or Parkinson's Disease.

Select...

I have severe diabetes complications like kidney problems or need dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Glycosylated hemoglobin A

Anxiety

Mental Depression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LUNA GroupExperimental Treatment4 Interventions

The LUNA Group is a culturally appropriate, E-Health enhanced, patient-centered, team-care model that includes: 1) care coordination by a Care Coordinator (CC) trained in electronic health records (EHR) clinical decision support and health promotion methods; 2) visits with a specially trained Behavioral Health Provider (BHP) with knowledge of diabetes and psychosocial aspects of diabetes; 3) care integration with primary care provider (PCP) implemented using the clinical decision support dashboard and/or synchronous communication during visits; and 4) a video adapted, evidence-based diabetes self-management education and support curriculum delivered through a learning management system.

Group II: Care CoordinationActive Control1 Intervention

The Care Coordination group applies the current methods of the federally qualified health center (FHQC) Patient Centered Medical Home initiative. Participants assigned to the care coordination group will continue with their regular medical visits with their primary care provider. In addition, they will receive care coordination and brief targeted health education provided by a specially trained medical assistant/care coordinator. This will involve 1 or more brief sessions with a care coordinator to provide health education, assist with appointments and referrals, and review medications. The care coordinator will work closely with their primary care provider. The care coordinator will also assist with referrals to behavioral health that may be initiated by the primary care provider.

0 / 4Eligibility 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

Common treatments for blood sugar control include lifestyle interventions, medications, and technology-assisted care. Lifestyle changes such as diet and exercise improve insulin sensitivity and lower blood glucose levels. Medications like metformin reduce hepatic glucose production and enhance insulin sensitivity, while insulin therapy directly facilitates glucose uptake by cells. E-Health tools, including web portals and telemedicine, improve patient engagement and adherence through secure messaging and remote monitoring. These treatments are essential for blood sugar control patients as they offer comprehensive, coordinated care that addresses both medical and psychological needs, leading to better glycemic control and reduced psychological distress.

Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care-results of the cluster-randomised controlled DEBATE trial.A systematic review of studies of web portals for patients with diabetes mellitus.Telemedicine for the Management of Glycemic Control and Clinical Outcomes of Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Studies.