What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes, such as insulin therapy and continuous glucose monitoring (CGM), have known side effects. Insulin therapy, including multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII), can lead to hypoglycemia, weight gain, and injection site reactions. CGM systems, which aid in self-regulation, may cause skin irritation or allergic reactions at the sensor site. These treatments are crucial for managing blood glucose levels but come with these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes (T1D) that focus on improving glycemic control and patient outcomes. These include insulin therapies, such as rapid-acting, long-acting, and premixed insulin formulations, which are essential for managing blood glucose levels. Additionally, continuous glucose monitors (CGMs) and insulin pumps have been approved to aid in better self-regulation and management of T1D. While the FAMS-T1D trial focuses on enhancing self-regulation and social support, these FDA-approved treatments provide the necessary tools for effective diabetes management, which can be complemented by behavioral interventions.

What other types of research exist?

Promising alternatives to FAMS-T1D for Type 1 Diabetes patients in 2024 include hybrid closed-loop (HCL) systems, such as the MiniMed 670G and Tandem T Slim X2 with Basal-IQ, which have shown to improve glycemic outcomes and patient satisfaction. Continuous glucose monitoring (CGM) systems and sensor-augmented insulin pumps are also effective in enhancing diabetes management. These technologies offer automated insulin delivery and predictive low glucose suspend functions, which can significantly improve time in range (TIR) and reduce hypoglycemia.

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Behavioral Intervention

FAMS-T1D Support Program for Type 1 Diabetes (FAMS-T1D Trial)

N/A

Waitlist Available

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Persons with diabetes aged 18-24

Diagnosed with T1D and has been taking insulin for at least one year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6, 9, and 12 months post baseline

Summary

This trial tests a program called FAMS-T1D that helps young adults with type 1 diabetes manage their condition. The program includes regular coaching calls, frequent text messages, and optional support from a friend or family member. The goal is to improve blood sugar control and reduce diabetes-related stress by providing consistent advice and encouragement.

Who is the study for?

This trial is for adults over 18 with Type 1 Diabetes who are comfortable texting and fluent in English. They need a support person who can communicate in English or Spanish. Participants should either have an A1c value of 7.5% or higher, or show signs of diabetes distress. Those with severe mental illness, sensory disabilities, or plans to live abroad during the study cannot join.

What is being tested?

The FAMS-T1D program aims to help young adults manage their Type 1 Diabetes by setting goals and getting social support. The study checks if this digital intervention improves blood glucose control, self-management, reduces stress related to diabetes, and helps without burdening the support persons.

What are the potential side effects?

Since this trial involves a behavioral intervention using digital resources rather than medication, traditional side effects like those seen with drugs are not expected.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 24 years old and have diabetes.

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I have Type 1 Diabetes and have been on insulin for over a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6, 9, and 12 months post baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6, 9, and 12 months post baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6, 9, and 12 months post baseline 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 (Person with Diabetes)

Change in Self-Management (Person with Diabetes)

Secondary study objectives

Diabetes Distress (Person with Diabetes)

Other study objectives

Change in Diabetes Distress (support person)

Change in Disclosure (Person with Diabetes)

Change in Goal planning (Person with Diabetes)

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FAMS-T1DExperimental Treatment2 Interventions

Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support person will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.

Group II: Digital resources for diabetesPlacebo Group1 Intervention

Persons with type 1 diabetes will receive text messages as to how to access their HbA1c results and digital materials related to self-care behaviors for their diabetes. All support persons will receive digital materials about type 1 diabetes and how to provide helpful support to the person with diabetes.

0 / 2Eligibility 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 insulin to manage blood glucose levels. Insulin works by facilitating the uptake of glucose into cells, thereby lowering blood glucose levels. This is crucial for T1D patients, who lack the ability to produce insulin naturally. Additionally, treatments that enhance self-regulation and social support, such as those studied in the FAMS-T1D trial, focus on helping patients set and achieve diabetes management goals and providing emotional and practical support. These mechanisms are important because they not only improve glycemic control but also reduce diabetes-related distress, leading to better overall health outcomes.

Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes.Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes.Person-Centered Interactive Self-Management Support in Primary Health Care for People with Type 2 Diabetes: Protocol for a Randomized Controlled Trial.