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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

IDEA Trial Summary

This trial will test a new intervention to help 16-21 year olds with Type 1 Diabetes better manage their disease. The intervention is based on the idea that if these young adults feel more in control and supported, they will be more likely to stick to their care routine. If successful, this intervention could be used to help other groups manage chronic illnesses.

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.Check my eligibility

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).See study design

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.

IDEA Trial 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.

IDEA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hemoglobin A1c

Secondary outcome measures

Blood glucose testing

Diabetes Management Scale

IDEA 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

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,145 Total Patients Enrolled

Wayne State UniversityLead Sponsor

307 Previous Clinical Trials

108,133 Total Patients Enrolled

April Carcone, PhDPrincipal Investigator - Wayne State University

Wayne State University

Media Library

Motivational Enhancement System (MES) Clinical Trial Eligibility Overview. Trial Name: NCT04066959 — N/A

Type 1 Diabetes Research Study Groups: QPL & MES, Motivation Enhancement System (MES), Text Message Reminders (TXT), MES, QPL & TXT, Question Prompt List (QPL), Standard Medical Care, MES & TXT, QPL & TXT

Type 1 Diabetes Clinical Trial 2023: Motivational Enhancement System (MES) Highlights & Side Effects. Trial Name: NCT04066959 — N/A

Motivational Enhancement System (MES) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04066959 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study recruiting participants of 45 years or older?

"The researchers are hoping to enrol participants aged 16-25 in this trial."

Answered by AI

Are there any open slots for participants in this research program?

"Indeed, clinicaltrials.gov attests to the recruitment of this trial which was launched on November 16th 2020 and last updated on January 13th 2022. 350 participants need to be secured from a single medical facility."

Answered by AI

What qualifications must participants satisfy in order to be accepted into this research?

"To be included in this trial, potential participants must have diabetes and an autoimmune disorder while being between the ages of 16 and 25. In total, 350 individuals will take part in the study."

Answered by AI

How many participants are currently eligible for this research trial?

"Affirmative. According to clinicaltrials.gov, the trial was first posted on November 16th 2020 and is now actively recruiting participants. An approximate 350 people are needed at one research facility."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy

Idalski Carcone, April, Deborah A Ellis, Susan Eggly, Karen E MacDonell, Samiran Ghosh, Colleen Buggs-Saxton, and Steven J Ondersma. 2020. “Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/20191.

clinicaltrials.govStudy

Improving Diabetes in Emerging Adulthood

April Carcone 2020. "Improving Diabetes in Emerging Adulthood". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04066959.

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