Technology-Education Intervention for Type 1 Diabetes

(ROUTE-T1D Trial)

Not currently recruiting at 1 trial location

Overseen By Emma Straton

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Cancer, Cystic fibrosis, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young adolescents with type 1 diabetes consistently use continuous glucose monitors (CGM) to better manage their blood sugar levels. It provides diabetes education and parent coaching support to make CGM use easier and more effective for both children and their parents. Participants will either receive immediate support or begin support after a few months. Children aged 10 to 15, who have had type 1 diabetes for at least six months and are new to or restarting CGM, are ideal candidates for this trial. As an unphased trial, this study offers families a unique opportunity to receive tailored support and education to improve diabetes management.

Will I have to stop taking my current medications?

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

What prior data suggests that this behavioral intervention is safe for adolescents with Type 1 Diabetes?

Research has shown that diabetes education and parent coaching are generally well-received by families managing type 1 diabetes. In one study, parents who received coaching felt better emotionally after their child's diagnosis, suggesting that a support system can be beneficial and safe for families. Another study found that parents had positive experiences with coaching, which helped them manage their child's diabetes more effectively. Reports indicate no harm or negative effects from these types of support, making them a safe option for those joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a fresh approach to managing Type 1 Diabetes through technology and education, rather than traditional medication or insulin management alone. Unlike standard treatments that focus on direct physiological interventions, this trial emphasizes empowering individuals and families with knowledge and support. The program includes interactive video sessions with certified diabetes educators and peer parent consultants, fostering a community-based support system. This innovative method aims to enhance self-management skills and improve quality of life for both patients and their families.

What evidence suggests that this intervention is effective for improving CGM use in adolescents with type 1 diabetes?

This trial will compare two approaches: an immediate intervention and a wait-list/delayed intervention. Research has shown that teaching families about diabetes and coaching parents can assist those dealing with type 1 diabetes (T1D). Studies indicate that health coaching helps families provide better diabetes care, even if it doesn't change the child's overall quality of life. One study found that parental support can boost children's confidence in managing their diabetes and improve their blood sugar control. With the right guidance, children can manage their blood sugar levels more effectively. Coaching parents may also help them cope better with the stress of managing their child's diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Randi Streisand, PhD

Principal Investigator

Children's National Hosptial

Are You a Good Fit for This Trial?

This trial is for young adolescents aged 10-15 with type 1 diabetes for at least 6 months, who are starting or restarting a continuous glucose monitor (CGM) after not using it for a year. It's not suitable for those under 10 or over 15, currently using CGM, diagnosed less than 6 months ago, or with major conditions like cancer.

Inclusion Criteria

I have been diagnosed with type 1 diabetes for over 6 months.

I am starting or restarting a continuous glucose monitor after a year.

I am between 10 and 15 years old.

Exclusion Criteria

You have been using a continuous glucose monitor recently.

I am either under 10 or over 15 years old.

I have a major medical condition like another cancer or cystic fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Intervention

Participants in the immediate intervention group participate in 3 video-conferencing sessions with a Certified Diabetes Care and Education Specialist (CDCES) and connect with a peer parent consultant

3 months

3 video-conferencing sessions

Delayed Intervention

Participants in the delayed intervention group receive no intervention for 6 months post-randomization, then participate in 3 video-conferencing sessions with a CDCES and connect with a peer parent consultant

9 months

3 video-conferencing sessions after 6 months

Follow-up

Participants are monitored for CGM use, diabetes self-management, glycemic control, glycemic variability, family conflict, diabetes distress, and CGM benefits and burdens

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Education and Parent Coaching Support

Trial Overview The study tests a behavioral intervention aimed to help these adolescents use CGM effectively. The focus is on optimizing technology usage through diabetes education and parent coaching support, especially targeting groups often left out of such research.

How Is the Trial Designed?

Group I: Immediate intervention Experimental Treatment 1 Intervention

Participants randomized to the immediate intervention group will participate in 3 video-conferencing sessions with a Certified Diabetes Care and Education Specialist (CDCES) interventionist and connect with a peer parent consultant immediately post randomization (expected intervention duration: 3 months).

Group II: Wait-list/delayed intervention Active Control 1 Intervention

Participants randomized to the delayed intervention group will receive no intervention for 6 months post-randomization; after the 6-month follow-up period, the delayed intervention group also will participate in 3 video conferencing sessions with a CDCES interventionist and connect with a peer parent consultant (expected intervention duration: 3 months).

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Published Research Related to This Trial

A trial involving 308 children with type 1 diabetes found that standardized self-management kits did not improve glycemic control, as evidenced by no significant change in HbA1c levels after 6 months, with only 18% of participants achieving recommended levels.

While the kits initially reduced worry about diabetes management at 3 months, they ultimately led to increased worry and decreased treatment adherence by 6 months, suggesting that the kits may have hindered effective self-management rather than helping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness. Noyes, J., Allen, D., Carter, C., et al.[2023]

Parents of young children with type 1 diabetes reported that remote monitoring technology significantly improved their ability to manage their child's glucose levels, allowing them to engage in non-diabetes-related activities while still overseeing their child's care.

The use of a hybrid closed-loop insulin delivery system increased parents' confidence in allowing others to care for their children, enabling kids to enjoy activities like sleepovers and parties without constant parental supervision, although some parents expressed a need for breaks from caregiving responsibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study. Hart, RI., Kimbell, B., Rankin, D., et al.[2022]

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 pilot study involving 30 mothers of young children with type 1 diabetes showed that a phone-based intervention was feasible and well-accepted, with over 80% of participants completing the program and reporting high satisfaction.

The intervention group experienced significant improvements in social support and quality of life over time, and there was a trend suggesting it may help mitigate the impact of maternal depressive symptoms on the child's glycemic control (HbA1c).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of a Pilot Intervention for Parents of Young Children Newly Diagnosed with Type 1 Diabetes. Mackey, ER., Herbert, L., Monaghan, M., et al.[2020]

In a 12-month randomized controlled trial involving 92 adolescents with type 1 diabetes, the diabetes self-management app 'bant' did not show significant changes in overall clinical outcomes like HbA1c compared to usual care.

However, for participants using self-monitoring of blood glucose (SMBG) at least 5 times daily, there was a notable improvement in HbA1c by 0.58%, suggesting that increased engagement with the app may enhance glycemic control in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. Goyal, S., Nunn, CA., Rotondi, M., et al.[2023]

A mobile application was developed to help adolescents with type 1 diabetes manage their condition as they transition to adulthood, based on their specific care needs and expectations.

In a test with 35 participants aged 16-25, the app received high user satisfaction scores, indicating it effectively supports disease self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing the "Healthcare CEO App" for patients with type 1 diabetes transitioning from adolescence to young adulthood: A mixed-methods study. Chiang, YT., Chang, CW., Yu, HY., et al.[2023]

Citations

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Coaching for parents of children with type 1 diabetes A health coach was a positive addition to pediatric T1D care for most families. Coaching did not impact overall child quality of life.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38422950/

Coaching for parents of children with type 1 diabetes To assess the effectiveness of a standardized bi-weekly six-month telephone coaching intervention for parents of children with type 1 diabetes.

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Parenting interventions for parents of children with type 1 ... This systematic review (1) summarizes and appraises the effectiveness of parenting interventions in pediatric diabetes on outcomes related to ...

4. formative.jmir.org formative.jmir.org/2023/1/e41193

Supporting Parents of Children With Type 1 Diabetes This pilot study sought to find ways to help parents with children with T1D in coping with stresses related to managing and monitoring their child's disease.

5. jcrpe.org jcrpe.org/articles/the-effect-of-parental-collaboration-on-diabetes-self-efficacy-quality-of-life-and-hba1c-level-in-adolescents-diagnosed-with-type-1-diabetes/jcrpe.galenos.2024.2024-4-7

The Effect of Parental Collaboration on Diabetes Self ... This study was conducted to determine the effect of parental support on adolescents' self-efficacy, quality of life (QoL) and glycaemic control in adolescents ...

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First STEPS: Primary Outcomes of a Randomized ... First STEPS improved parents' mood following young children's type 1 diabetes diagnosis. Results indicate likely benefits of parent coach support.

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Parent Engagement in School Health Decisions for Type 1 ... Parent engagement is a frequently cited barrier to school health interventions. Little is known about what influences parent involvement in ...

8. mdpi.com mdpi.com/2227-9067/11/9/1036

Experiences of Parent Coaches in an Intervention for ... This paper explores parent coaching experiences supporting parents of young children newly diagnosed with type 1 diabetes in a clinical trial.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02527525

NCT02527525 | First STEPS- Study of Type 1 in Early ... The aim of this randomized controlled trial (RCT) is to determine the efficacy of a stepped care intervention that provides participants with up to 3 intensity ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822724006636

Participation and psychosocial supports in the school ... This discrete-choice experiment describes parental preference for enhanced psychosocial and activity-focused supports over academic supports for children with ...