Improving Diabetes in Emerging Adulthood
IDEA
Improving Diabetes Health in Emerging Adulthood Through an Autonomy Supportive Intervention
2 other identifiers
interventional
113
1 country
1
Brief Summary
This project will test the efficacy of a multi-component behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-21) with T1D, a group with chronic poor metabolic control. This intervention is grounded in self-determination theory which states that a youth who believes their diabetes management is self-directed, competent, and supported by others is more likely to consistently complete their diabetes self-care. This theory-driven intervention will be scalable to a variety of chronic illness contexts and the knowledge gained from this research will inform self-determination theory and different interventions targeting this population (currently there are no interventions that directly target emerging adults).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2025
CompletedResults Posted
Study results publicly available
May 5, 2026
CompletedMay 5, 2026
April 1, 2026
4.2 years
July 24, 2019
March 26, 2026
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
Hb1Ac will be obtained by using the Accubase A1c test kit.
Baseline/0 month, Treatment End/3 months, and Follow Up/6 months
Secondary Outcomes (1)
Diabetes Management Scale
Baseline/0 month, Treatment End/3 months, and Follow Up/6 months
Study Arms (8)
Question Prompt List (QPL)
EXPERIMENTALA 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.
Motivation Enhancement System (MES)
EXPERIMENTALMES 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.
Text Message Reminders (TXT)
EXPERIMENTALParticipants 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.
QPL & MES
EXPERIMENTALParticipants will receive the QPL and MES interventions as described above.
QPL & TXT
EXPERIMENTALParticipants will receive the QPL and TXT interventions as described above.
MES & TXT
EXPERIMENTALParticipants will receive the MES and TXT interventions as described above.
MES, QPL & TXT
EXPERIMENTALParticipants will receive the MES, QPL, and TXT interventions as described above.
Standard Medical Care
NO INTERVENTIONParticipants 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.
Interventions
MES is a brief eHealth intervention delivered via an internet-based software application. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. The goal of MES is to increase motivation to complete daily diabetes care tasks. MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting.
A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit. The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations. Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care. QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit.
TXT is a behavioral support strategy composed of one-way text message reminders to promote daily diabetes care task completion. TXT is supported by social cognitive theory which suggests that consistent task completion leads to perceptions of control and supports goal attainment. TXT may also foster a stronger relationship with diabetes care providers through greater communication and satisfaction. Youth will receive daily reminders to complete key diabetes care tasks.
Eligibility Criteria
You may qualify if:
- Age 16 years, 0 months - 25 years, 11 months
- Type 1 diabetes (T1D)
- HbA1c ≥7.5% currently and averaged over the previous 6 months
- Duration of diabetes ≥6 months
- English fluency, both verbal and written
- Cell phone access with texting capability
You may not qualify if:
- Psychosis (e.g., schizophrenia or bipolar disorder)
- Suicidal
- Developmental delay (moderate or severe mental retardation, or autism) or reading level below sixth grade
- The presence of another physical health condition that results in atypical diabetes management (e.g., cystic fibrosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Detroit Medical Center
Detroit, Michigan, 48201, United States
Related Publications (4)
Ellis DA, Carcone AI, Buggs-Saxton C, Bhan A, Dekelbab MB. Effects of individual, health system and neighborhood risks on diabetes health outcomes among emerging adults with type 1 diabetes. Diabetes research and clinical practice. 2025 Aug 7:112415.
RESULTIdalski Carcone A, Holtz BE, Reardon M, Vesey D, Ellis DA, Parks M. Meeting the Needs of Emerging Adults With Type 1 Diabetes Living in a Rural Area With Mobile Health Interventions: Focus Group Study. JMIR Form Res. 2024 Aug 7;8:e55650. doi: 10.2196/55650.
PMID: 39110496RESULTIdalski Carcone A, Baskar D, Mahmood A, MacDonell K, Eggly S, Ghosh S, Buggs-Saxton C, Ondersma SJ, Ellis DA. Developing eHealth Interventions to Improve Diabetes Management in Emerging Adulthood: Qualitative Formative Study. JMIR Form Res. 2025 Nov 27;9:e75623. doi: 10.2196/75623.
PMID: 41313164RESULTIdalski Carcone A, Ellis DA, Eggly S, MacDonell KE, Ghosh S, Buggs-Saxton C, Ondersma SJ. Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy. JMIR Res Protoc. 2020 Oct 20;9(10):e20191. doi: 10.2196/20191.
PMID: 33079068RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1\) COVID-19 interruptions and other recruitment challenges led to under-enrollment and an an inability to conduct the planned analyses. 2) Changes in clinical practice over the course of the study resulted in many participants experiencing a change in their blood glucose monitoring device which, in turn, made the blood glucose monitoring metric (i.e., tests/day) missing for a significant proportion of the sample with and across participants.
Results Point of Contact
- Title
- April Idalski Carcone, PhD, MSW
- Organization
- Wayne State University
Study Officials
- PRINCIPAL INVESTIGATOR
April Carcone, PhD
Wayne State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor/data collector will be kept blind to treatment assignments to the extent possible in a behavioral trial.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 24, 2019
First Posted
August 26, 2019
Study Start
November 16, 2020
Primary Completion
January 13, 2025
Study Completion
January 13, 2025
Last Updated
May 5, 2026
Results First Posted
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share