Diabetes Mellitus, Type 1IDEANCT04066959
Improving Diabetes in Emerging Adulthood
A study testing Motivational Enhancement System (MES), Question Prompt List (QPL) and Text Message Reminders (TXT) in people with Diabetes Mellitus, Type 1, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Motivational Enhancement System (MES), Question Prompt List (QPL) and Text Message Reminders (TXT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Diabetes Health in Emerging Adulthood Through an Autonomy Supportive Intervention
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).
Read the detailed description
This project will use the multiphase optimization strategy (MOST) approach to test the efficacy of an autonomy supportive behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-25) with T1D. Youth this age demonstrate chronic poor metabolic control that persists into adulthood leading to the premature emergence of short- and long-term diabetes complications. Developmentally, adolescence and emerging adulthood is a time when the need for independence and autonomy are particularly salient. This new intervention will leverage youths' desire for autonomy by designing an intervention to support diabetes self-management autonomy. This intervention is guided by self-determination theory (SDT) which suggests that autonomous (i.e., self-initiated, driven by intrinsic versus extrinsic motivation) diabetes management depends upon three conditions: 1) the perception that one's behavior is self-directed, 2) feelings of competence, or self-efficacy, and 3) the existence of caring relationships supportive of the behavior. The investigators have identified three intervention components that target the SDT constructs. A question prompt list (QPL) is a simple, inexpensive tool comprised of a list of questions that patients might consider asking their health care provider during a clinic visit. QPLs empower patients to assume a more active role (asking questions and stating concerns) during clinic visits. The Motivation Enhancing System (MES) is an eHealth intervention to increase intrinsic motivation for health behavior change. MES content is based on the Motivational Interviewing (MI) framework and the Information-Motivation-Behavioral Skills (IMB) model of health behavior change which posits that behavior change results from the joint function of three critical components: accurate information about risk behaviors or their replacement health behaviors, motivation to change behavior, and behavioral skills necessary to perform the behavior (self-efficacy). Text message reminders (TXT) are a strategy to encourage youth to complete their diabetes self-care that also lead to gains in self-efficacy and a stronger relationship with diabetes care providers through greater communication and satisfaction. The investigators will test the efficacy of these intervention components toward improving metabolic control in a component selection experiment (N=320). The experiment will use a full factorial research design with random assignment to determine which intervention components contribute to a clinically significant improvement (≥0.5%) in HbA1c. The result of this research will be an optimized, multi-component intervention with effect size estimates that will be used to inform a large scale, fully powered effectiveness trial. 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 behavioral interventions targeting this population (for which there currently are none).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Motivational Enhancement System (MES), Question Prompt List (QPL), Text Message Reminders (TXT)
- Keywords
- emerging adults, ehealth intervention, diabetes, diabetes management, adolescents, self-determination theory
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement System (MES)Behavioural
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.
Question Prompt List (QPL)Behavioural
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.
Text Message Reminders (TXT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Question Prompt List (QPL) | Experimental | 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. Receives: Behavioral: Question Prompt List (QPL) |
| Motivation Enhancement System (MES) | Experimental | 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. Receives: Behavioral: Motivational Enhancement System (MES) |
| Text Message Reminders (TXT) | Experimental | 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. Receives: Behavioral: Text Message Reminders (TXT) |
| QPL & MES | Experimental | Participants will receive the QPL and MES interventions as described above. Receives: Behavioral: Motivational Enhancement System (MES); Behavioral: Question Prompt List (QPL) |
| QPL & TXT | Experimental | Participants will receive the QPL and TXT interventions as described above. Receives: Behavioral: Question Prompt List (QPL); Behavioral: Text Message Reminders (TXT) |
| MES & TXT | Experimental | Participants will receive the MES and TXT interventions as described above. Receives: Behavioral: Motivational Enhancement System (MES); Behavioral: Text Message Reminders (TXT) |
| MES, QPL & TXT | Experimental | Participants will receive the MES, QPL, and TXT interventions as described above. Receives: Behavioral: Motivational Enhancement System (MES); Behavioral: Question Prompt List (QPL); Behavioral: Text Message Reminders (TXT) |
| Standard Medical Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Hb1Ac will be obtained by using the Accubase A1c test kit.
Measured: Baseline/0 month, Treatment End/3 months, and Follow Up/6 months
Secondary outcomes (1)
Diabetes Management Scale
The Diabetes Management Scale (DMS) is a self-report measure of diabetes illness management assessing a broad range of diabetes management behaviors, including insulin management, dietary management, blood glucose monitoring, and symptom response with good internal consistency (α=.74 to .84). Ten items ask "What percent of the time do you (diabetes care task)?" with a response scale of 0-100% where higher scores indicate greater (better) diabetes management. A total score, ranging form 0-100%, is obtained by calculating the average response across ten items to reflect overall management behavior.
Measured: Baseline/0 month, Treatment End/3 months, and Follow Up/6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start16 Nov 2020
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study will use an 8-arm full factorial design. In arms 1-3 participants will receive 1 of the 3 intervention components, arms 4-6 receive a combination of 2 components, arm 7 receives all 3 components, and arm 8 is the standard care control. The study will use the mixed effects linear model for the ANOVA of a factorial design powered on the main effects to identify the intervention components that significantly contribute to a clinically significant improvement in HbA1c. Each model will include a random intercept and slope and fixed effects for treatment combinations and time, as well as the stratification variable. The component selection experiment will result in empirical evidence supporting the efficacy of an autonomy support intervention composed of one or more components to improve metabolic control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Carcone, Wayne State University
- Investigators
- April Carcone, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066959
- Sponsor's protocol ID
- R01DK116901
- Other IDs
- 1R01DK116901-01A1
- Acronym
- IDEA
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2019
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Res Clin Pract. 2025 Sep;227:112415. doi: 10.1016/j.diabres.2025.112415. Epub 2025 Aug 7.
PubMed 40782842Idalski 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.
PubMed 39110496Idalski 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.
PubMed 41313164Idalski 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.
PubMed 33079068
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Health in Emerging Adulthood Through an Autonomy Supportive Intervention
- ClinicalTrials.gov ID
- NCT04066959
- Acronym / sponsor ID
- IDEA / R01DK116901
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- emerging adults, ehealth intervention, diabetes, diabetes management, adolescents, self-determination theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This project will use the multiphase optimization strategy (MOST) approach to test the efficacy of an autonomy supportive behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-25) with T1D. Youth this age demonstrate chronic poor metabolic control that persists into adulthood leading to the premature emergence of short- and long-term diabetes complications. Developmentally, adolescence and emerging adulthood is a time when the need for independence and autonomy are particularly salient. This new intervention will leverage youths' desire for autonomy by designing an intervention to support diabetes self-management autonomy. This intervention is guided by self-determination theory (SDT) which suggests that autonomous (i.e., self-initiated, driven by intrinsic versus extrinsic motivation) diabetes management depends upon three conditions: 1) the perception that one's behavior is self-directed, 2) feelings of competence, or self-efficacy, and 3) the existence of caring relationships supportive of the behavior. The investigators have identified three intervention components that target the SDT constructs. A question prompt list (QPL) is a simple, inexpensive tool comprised of a list of questions that patients might consider asking their health care provider during a clinic visit. QPLs empower patients to assume a more active role (asking questions and stating concerns) during clinic visits. The Motivation Enhancing System (MES) is an eHealth intervention to increase intrinsic motivation for health behavior change. MES content is based on the Motivational Interviewing (MI) framework and the Information-Motivation-Behavioral Skills (IMB) model of health behavior change which posits that behavior change results from the joint function of three critical components: accurate information about risk behaviors or their replacement health behaviors, motivation to change behavior, and behavioral skills necessary to perform the behavior (self-efficacy). Text message reminders (TXT) are a strategy to encourage youth to complete their diabetes self-care that also lead to gains in self-efficacy and a stronger relationship with diabetes care providers through greater communication and satisfaction. The investigators will test the efficacy of these intervention components toward improving metabolic control in a component selection experiment (N=320). The experiment will use a full factorial research design with random assignment to determine which intervention components contribute to a clinically significant improvement (≥0.5%) in HbA1c. The result of this research will be an optimized, multi-component intervention with effect size estimates that will be used to inform a large scale, fully powered effectiveness trial. 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 behavioral interventions targeting this population (for which there currently are none).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- Model description
- The study will use an 8-arm full factorial design. In arms 1-3 participants will receive 1 of the 3 intervention components, arms 4-6 receive a combination of 2 components, arm 7 receives all 3 components, and arm 8 is the standard care control. The study will use the mixed effects linear model for the ANOVA of a factorial design powered on the main effects to identify the intervention components that significantly contribute to a clinically significant improvement in HbA1c. Each model will include a random intercept and slope and fixed effects for treatment combinations and time, as well as the stratification variable. The component selection experiment will result in empirical evidence supporting the efficacy of an autonomy support intervention composed of one or more components to improve metabolic control.
| Arm | Type | Receives |
|---|---|---|
| Question Prompt List (QPL) | Experimental | Behavioral: Question Prompt List (QPL)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. |
| Motivation Enhancement System (MES) | Experimental | Behavioral: Motivational Enhancement System (MES)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. |
| Text Message Reminders (TXT) | Experimental | Behavioral: Text Message Reminders (TXT)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. |
| QPL & MES | Experimental | Behavioral: Motivational Enhancement System (MES), Behavioral: Question Prompt List (QPL)Participants will receive the QPL and MES interventions as described above. |
| QPL & TXT | Experimental | Behavioral: Question Prompt List (QPL), Behavioral: Text Message Reminders (TXT)Participants will receive the QPL and TXT interventions as described above. |
| MES & TXT | Experimental | Behavioral: Motivational Enhancement System (MES), Behavioral: Text Message Reminders (TXT)Participants will receive the MES and TXT interventions as described above. |
| MES, QPL & TXT | Experimental | Behavioral: Motivational Enhancement System (MES), Behavioral: Question Prompt List (QPL), Behavioral: Text Message Reminders (TXT)Participants will receive the MES, QPL, and TXT interventions as described above. |
| Standard Medical Care | No 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. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Enhancement System (MES)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. | Behavioural | MES & TXT, MES, QPL & TXT, Motivation Enhancement System (MES), QPL & MES |
| Question Prompt List (QPL)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. | Behavioural | MES, QPL & TXT, QPL & MES, QPL & TXT, Question Prompt List (QPL) |
| Text Message Reminders (TXT)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. | Behavioural | MES & TXT, MES, QPL & TXT, QPL & TXT, Text Message Reminders (TXT) |
Primary outcome
Hemoglobin A1c
Time frame: Baseline/0 month, Treatment End/3 months, and Follow Up/6 months
Hb1Ac will be obtained by using the Accubase A1c test kit.
1 secondary outcome
Diabetes Management Scale
Time frame: Baseline/0 month, Treatment End/3 months, and Follow Up/6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40782842Ellis 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 Res Clin Pract. 2025 Sep;227:112415. doi: 10.1016/j.diabres.2025.112415. Epub 2025 Aug 7.
- Results publication: PubMed 39110496Idalski 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.
- Results publication: PubMed 41313164Idalski 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.
- Results publication: PubMed 33079068Idalski 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.
- Principal Investigator-hosted website to share the dissemination products from the research.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April Carcone, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement System (MES), Question Prompt List (QPL) and Text Message Reminders (TXT) in people with Diabetes Mellitus, Type 1, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Baseline/0 month, Treatment End/3 months, and Follow Up/6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066959, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.