Supportive Intervention for Type 1 Diabetes

(IDEA Trial)

Overseen By Abigale Vaquera, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

350 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Supportive Intervention for Type 1 Diabetes is an effective treatment?

The available research shows that a text-messaging system called Sweet Talk was tested to help young people with Type 1 diabetes. This system aimed to boost their confidence in managing their condition and improve their blood sugar control. The study found that using Sweet Talk helped these young patients better manage their diabetes, suggesting that Supportive Intervention for Type 1 Diabetes can be an effective treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Motivational Enhancement System (MES) and related components for Type 1 Diabetes?

Research shows that text messaging systems, like those used in the Motivational Enhancement System, have been effective in supporting young people with diabetes by improving their confidence in managing their condition and helping them maintain better blood sugar control. ^{1 2 3 4 5}

What safety data is available for the supportive intervention for Type 1 Diabetes?

The available research primarily focuses on text messaging interventions for asthma management, not Type 1 Diabetes. These studies indicate that text messaging systems are generally well-received and can improve adherence and quality of life in asthma patients. However, specific safety data for the intervention in Type 1 Diabetes is not provided in the available research. ^{1 2 6 7 8}

Is the text messaging intervention generally safe for humans?

The text messaging intervention has been tested in studies with teenagers and adults for asthma management, and participants found it acceptable and safe. There were no reports of harm or safety concerns in these studies. ^{1 2 6 7 8}

Is the treatment in the trial 'Supportive Intervention for Type 1 Diabetes' a promising treatment?

The information provided does not directly relate to the trial 'Supportive Intervention for Type 1 Diabetes', so we cannot determine if it is a promising treatment based on the given data. ^{1 6 7 9 10}

How does the supportive intervention for Type 1 Diabetes differ from other treatments?

The supportive intervention for Type 1 Diabetes may involve a novel approach similar to text messaging programs used in asthma management, which provide tailored and interactive messages to support self-management. This approach is unique as it focuses on enhancing patient engagement and adherence through personalized communication, rather than traditional medication or insulin therapy. ^{1 6 7 9 10}

Research Team

April Carcone, PhD

Principal Investigator

Wayne State University

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with type 1 diabetes.

I have had diabetes for at least 6 months.

English fluency, both verbal and written

Exclusion Criteria

You have a serious mental illness like schizophrenia or bipolar disorder.

You have a significant learning delay or difficulty reading at a level below sixth grade.

You have thoughts of hurting yourself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multi-component behavioral intervention including MES, QPL, and TXT to improve metabolic control

3 months

2 sessions (in-person) for MES, routine diabetes clinic visits every 3-4 months

Follow-up

Participants are monitored for changes in HbA1c and diabetes management behaviors post-treatment

3 months

Treatment Details

Interventions

• Motivational Enhancement System (MES)
• Question Prompt List (QPL)
• Text Message Reminders (TXT)

Trial Overview 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).

Participant Groups

Group I: Text Message Reminders (TXT) Experimental Treatment 1 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 Treatment 1 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 & TXT Experimental Treatment 2 Interventions

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

Group IV: QPL & MES Experimental Treatment 2 Interventions

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

Group V: Motivation Enhancement System (MES) Experimental Treatment 1 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 & TXT Experimental Treatment 3 Interventions

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

Group VII: MES & TXT Experimental Treatment 1 Intervention

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

Group VIII: Standard Medical Care Active Control 1 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 Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A pilot study with 12 teenagers showed that a customizable text messaging system for asthma reminders was well-received, with high ratings for usefulness and ease of use.

While the teens created 18 unique medication reminders, there was no change in their self-reported asthma control, suggesting that while the system is acceptable, it may not directly improve asthma management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot and feasibility test of adolescent-controlled text messaging reminders. Britto, MT., Munafo, JK., Schoettker, PJ., et al.[2015]

In a 6-month study with 64 adolescents aged 12 to 22 with poorly controlled asthma, personalized text messaging improved adherence to asthma management by 2.75% each month during the intervention period.

Participants reported better quality of life and reduced worry about their asthma while receiving text messages, although these improvements in asthma control were not sustained after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. Britto, MT., Rohan, JM., Dodds, CM., et al.[2017]

The Question Prompt List for Clinical Trials (QPL-CT) was developed and tested with 30 cancer patients, showing that it effectively encourages patients to ask questions about their personal benefits from clinical trials during consultations with oncologists.

Despite the QPL-CT's potential to improve communication, some patients still had unasked and unanswered questions, indicating that further research is needed to fully assess its impact on patient outcomes in clinical trial discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the utility of a cancer clinical trial specific Question Prompt List (QPL-CT) during oncology consultations. Brown, RF., Bylund, CL., Li, Y., et al.[2021]

A study involving 20 adults with asthma and/or COPD highlighted the importance of accessible and timely support from healthcare professionals, particularly during exacerbations, to enhance self-management.

Participants emphasized the need for comprehensive, person-centered care and valued strong relationships with healthcare providers who acknowledge their concerns, suggesting that effective communication and continuity of care are crucial for managing their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The preferences of people with asthma or chronic obstructive pulmonary disease for self-management support: A qualitative descriptive study. O'Connell, S., McCarthy, VJC., Queally, M., et al.[2021]

The Sweet Talk text-messaging system significantly improved diabetes self-efficacy and adherence among adolescents with Type 1 diabetes, with patients reporting better self-management and a desire to continue using the service.

While Sweet Talk alone did not lead to improved glycaemic control, it was effective in supporting the transition to intensive insulin therapy, suggesting its potential as a valuable tool in managing diabetes in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. Franklin, VL., Waller, A., Pagliari, C., et al.[2022]

A study involving 43 participants with persistent asthma showed that most were receptive to an SMS intervention for asthma management, particularly favoring tailored and interactive messages.

Adolescents expressed interest in sending messages to a support person, while adults were less enthusiastic; participants preferred directive educational content over general reminders about their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspectives on a Text Messaging Program to Support Asthma Management: A Qualitative Study. Doyle, R., Albright, K., Hurley, LP., et al.[2022]

A systematic review of five randomized controlled trials found mixed results regarding the effectiveness of text message reminders in improving asthma medication adherence, indicating that while results vary, reminders can help address forgetfulness.

Despite limited evidence supporting widespread effectiveness, text messaging is recognized as a promising tool for enhancing medication adherence in patients with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Effectiveness of Text Message Reminders on Asthma Medication Adherence. Dong, J., Reeves, L., Ali, A., et al.[2022]

A study involving 171 patients showed that SMS-based health education messages significantly improved fasting plasma glucose levels and control rates compared to regular education, indicating the effectiveness of this intervention for managing chronic diseases.

The intervention group also demonstrated better self-management behaviors, including increased vegetable and fruit consumption, weight control, and physical activity, highlighting the feasibility of using SMS to promote healthier habits in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial. Wang, X., Liu, D., Du, M., et al.[2020]

A new 17-item questionnaire was developed to categorize adolescents with asthma into six motivation-based archetypes, which can help tailor self-management interventions for better adherence.

This study demonstrates that a brief questionnaire can effectively identify different motivational profiles, allowing healthcare professionals to customize interventions like motivational interviewing during clinic visits, especially in time-constrained primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a motivation-based tool to facilitate individualized self-management interventions for adolescents with asthma. Byczkowski, TL., Vockell, AB., Krier, DJ., et al.[2022]

A motivational interviewing (MI) based asthma self-management program was developed and successfully implemented with 37 inner-city African-American adolescents, showing high completion rates (95%) and positive feedback from caregivers and adolescents about its benefits.

Post-intervention, caregivers reported improved medication adherence and adolescents expressed increased motivation to manage their asthma, along with significant improvements in asthma-related quality of life, indicating that MI could be an effective strategy for enhancing asthma management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a motivational interviewing intervention to promote medication adherence among inner-city, African-American adolescents with asthma. Riekert, KA., Borrelli, B., Bilderback, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot and feasibility test of adolescent-controlled text messaging reminders. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. [2017]

3. Ireland pubmed.ncbi.nlm.nih.gov

Testing the utility of a cancer clinical trial specific Question Prompt List (QPL-CT) during oncology consultations. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The preferences of people with asthma or chronic obstructive pulmonary disease for self-management support: A qualitative descriptive study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Patient Perspectives on a Text Messaging Program to Support Asthma Management: A Qualitative Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Effectiveness of Text Message Reminders on Asthma Medication Adherence. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Development of a motivation-based tool to facilitate individualized self-management interventions for adolescents with asthma. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

The development of a motivational interviewing intervention to promote medication adherence among inner-city, African-American adolescents with asthma. [2022]