What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes (T1D) include insulin therapy, continuous glucose monitoring (CGM), and lifestyle interventions. Insulin therapy, whether through injections or pumps, can cause side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions. Continuous glucose monitoring (CGM) devices may cause skin irritation or discomfort at the sensor site. Lifestyle interventions, including diet and exercise, generally have fewer side effects but require consistent adherence and can be challenging to maintain. Enhanced patient education, self-management, and peer support, as studied in Shared Medical Appointments (SMA), aim to mitigate these side effects by improving adherence and providing emotional and practical support.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes that align with the principles of enhanced patient education, self-management, and peer support. Insulin therapy remains the cornerstone of treatment, with various formulations such as rapid-acting, long-acting, and premixed insulins being approved. Additionally, continuous glucose monitors (CGMs) and insulin pumps have been approved to aid in better self-management and glycemic control. These technologies, combined with structured education programs and peer support groups, can significantly improve outcomes for individuals with Type 1 Diabetes. While specific drugs like teplizumab have been approved for delaying the onset of Type 1 Diabetes in high-risk individuals, the integration of these therapies with SMA principles can enhance overall disease management.

What other types of research exist?

Promising alternatives to SMAs for T1D patients include: 1) Web-based self-management tools that offer additional support and complement traditional healthcare services, such as interactive platforms for patient education and peer engagement. 2) Telemedicine and video-conference shared medical appointments, which provide remote access to healthcare professionals and peer support, especially beneficial for patients in rural or underserved areas. 3) Advanced insulin delivery systems like hybrid closed-loop (HCL) systems, which automate insulin delivery based on continuous glucose monitoring, improving glycemic control and quality of life.

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Group Visits for Type 1 Diabetes

Washington, United States

N/A

Recruiting

Led By Shideh Majidi, MD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

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

Must have

Poorly controlled T1D: one A1c value > 8% in the preceding year

Patients clinically diagnosed with T1D managed with insulin injections for at least 1 year

Must not have

Use of insulin pump therapy for diabetes management at time of enrollment

Concurrent use of any non-insulin diabetes medication to control blood glucose levels

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess if shared medical appointments help underserved youth with poorly controlled type 1 diabetes in terms of glycemic control, self-management skills, and health related quality of life.

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Who is the study for?

This trial is for underserved youth aged 8-11 with poorly controlled type 1 diabetes (T1D), who have public healthcare insurance, speak English, and are managed on insulin injections. Participants must be Non-Hispanic Black or Latinx and have had an A1c value over 8% in the past year. Those using insulin pumps, with significant cognitive issues or major psychiatric disorders, taking non-insulin diabetes meds, or involved in other studies can't join.Check my eligibility

What is being tested?

The study tests shared medical appointments (SMA) every three months for one year to see if they help improve blood sugar control, self-care skills, and quality of life in these kids. After the SMA visits end, there's a six-month observation period to evaluate how well SMAs work and if people like this approach.See study design

What are the potential side effects?

Since this trial focuses on group medical visits rather than a new medication or treatment device, traditional side effects aren't expected. However, participants may experience stress or discomfort from discussing their condition in a group setting.

Eligibility Criteria

Inclusion Criteria

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

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My diabetes control has been poor, with an A1c over 8% in the last year.

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I have been managing my Type 1 Diabetes with insulin injections for over a year.

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I am between 8 and 11 years old.

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Exclusion Criteria

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

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I use an insulin pump to manage my diabetes.

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I am using non-insulin medication to manage my diabetes.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 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

Frequency of SMA sessions attended, as assessed by tracking study visit attendance.

Perceived benefit of the SMA intervention content, as measured by user satisfaction surveys summary statistics (mean and standard deviation as well as percent answering a specific Likert level)

Perceived satisfaction of SMA intervention as assessed by user satisfaction surveys summary statistics (mean and standard deviation as well as percent answering a specific Likert level), and semi-structured interviews.

+3 more

Secondary study objectives

CGM Benefits and Burdens scale

Diabetes Self-Management Profile (DSMP) survey

Problem Areas in Diabetes (PAID) scale

+13 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: SMA visit intervention armExperimental Treatment1 Intervention

SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver

0 / 5Eligibility 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 treatment for Type 1 Diabetes (T1D) is insulin therapy, which involves administering exogenous insulin to regulate blood glucose levels due to the body's inability to produce insulin. Enhanced patient education and self-management skills are crucial as they enable patients to make informed decisions about insulin dosing, diet, and lifestyle, which are essential for maintaining optimal glycemic control. Peer support offers emotional and practical assistance, helping patients adhere to their treatment plans and improve their quality of life. These combined approaches address both the physiological and psychosocial aspects of T1D, leading to better clinical outcomes and overall well-being.

Dietitians' perspectives on challenges and prospects for group-based education to adults with type 1 diabetes - a qualitative study.E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.The role of theories in interventions targeting preteens with Type 1 diabetes: A critical literature review.