What side effects are associated with this type of intervention?

The most common treatment for Type 1 Diabetes is insulin therapy, which can cause side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions. Behavioral interventions, like the multi-component behavioral intervention based on self-determination theory, focus on enhancing self-management and social support. These interventions typically have fewer physical side effects but may include psychological impacts such as stress or anxiety related to behavior change and adherence to the treatment regimen.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 1 Diabetes that support self-directed management and competence. Notably, the FDA has permitted the marketing of digital therapeutics, such as game-based interventions, to improve attention and self-management in children with ADHD, which can be analogous to similar approaches in T1D. Additionally, insulin therapy remains a cornerstone of T1D management, with various formulations available to optimize glycemic control. Behavioral interventions, such as the Multi-component Behavioral Intervention grounded in self-determination theory, are being studied to enhance self-management, competence, and social support, although specific FDA approvals for such comprehensive behavioral programs in T1D are not detailed.

What other types of research exist?

Promising alternatives for T1D management in 2024 include: 1) Hybrid Closed-Loop (HCL) insulin delivery systems, which automate insulin dosing based on continuous glucose monitoring, improving glycemic control and quality of life. 2) Advanced digital health platforms offering personalized diabetes management plans, real-time data sharing, and remote monitoring by healthcare providers. 3) New pharmacological agents like dual-hormone artificial pancreas systems that use both insulin and glucagon to better mimic natural pancreatic function. 4) Integrated care models combining telemedicine, behavioral health support, and community resources to provide comprehensive, patient-centered care.

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Supportive Intervention for Type 1 Diabetes (IDEA Trial)

N/A

Recruiting

Led By April Carcone, PhD

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

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

Must have

Diagnosed with type 1 diabetes (T1D)

Duration of diabetes ≥6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program to help young people aged 16-25 with Type 1 Diabetes manage their condition better by making them feel more in control, confident, and supported.

Who is the study for?

This trial is for young people aged 16-25 with Type 1 Diabetes who have had high blood sugar levels over the past six months. Participants must speak and write English, be able to text, and have been diagnosed with diabetes for at least half a year. It's not open to those with severe mental health issues, developmental delays, or other conditions affecting diabetes management.

What is being tested?

The study tests a behavioral intervention based on self-determination theory aimed at improving how well these young adults manage their diabetes. The program includes a Question Prompt List (QPL), Motivational Enhancement System (MES), and Text Message Reminders (TXT).

What are the potential side effects?

Since this trial focuses on behavioral interventions rather than medication, traditional side effects are not expected. However, participants may experience stress or anxiety related to managing their condition more actively.

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 1 diabetes.

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I have had diabetes for at least 6 months.

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I am between 16 and 25 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hemoglobin A1c

Secondary study objectives

Blood glucose testing

Diabetes Management Scale

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Text Message Reminders (TXT)Experimental Treatment1 Intervention

Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.

Group II: Question Prompt List (QPL)Experimental Treatment1 Intervention

A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.

Group III: QPL & TXTExperimental Treatment2 Interventions

Participants will receive the QPL and TXT interventions as described above.

Group IV: QPL & MESExperimental Treatment2 Interventions

Participants will receive the QPL and MES interventions as described above.

Group V: Motivation Enhancement System (MES)Experimental Treatment1 Intervention

MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.

Group VI: MES, QPL & TXTExperimental Treatment3 Interventions

Participants will receive the MES, QPL, and TXT interventions as described above.

Group VII: MES & TXTExperimental Treatment1 Intervention

Participants will receive the MES and TXT interventions as described above.

Group VIII: Standard Medical CareActive Control1 Intervention

Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.

0 / 3Eligibility 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 is essential for replacing the insulin that the pancreas cannot produce, thereby maintaining normal blood glucose levels and preventing complications. Additionally, behavioral interventions like the Multi-component Behavioral Intervention enhance self-directed management, competence, and social support based on self-determination theory. These interventions empower patients to take control of their diabetes care, improve adherence to treatment, and foster a supportive environment, ultimately leading to better 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.