Technology-Education Intervention for Type 1 Diabetes

(ROUTE-T1D Trial)

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. The proposed study will conduct a feasibility trial of a behavioral intervention designed to optimize use of CGM in adolescents specifically targeting underrepresented populations in diabetes technology research.

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 data supports the effectiveness of the treatment Diabetes Education and Parent Coaching Support for Type 1 Diabetes?

Research shows that parent-focused interventions, like phone-based support, can improve blood sugar control and well-being in children with type 1 diabetes. Additionally, parents using remote monitoring technology report positive experiences, suggesting that technology-education interventions can be beneficial. ^{1 2 3 4 5}

Is the Technology-Education Intervention for Type 1 Diabetes safe for humans?

The research articles do not provide specific safety data for the Technology-Education Intervention or its related programs, but they focus on self-management and support tools for type 1 diabetes, which generally aim to improve well-being without indicating any safety concerns. ^{1 6 7 8 9}

How is the Diabetes Education and Parent Coaching Support treatment different from other treatments for type 1 diabetes?

This treatment is unique because it combines education and coaching support specifically for parents, helping them manage their child's type 1 diabetes more effectively. Unlike traditional treatments that focus solely on the patient, this approach involves parents in the management process, which can improve both glycemic control and family well-being. ^{1 7 8 10 11}

Research Team

Randi Streisand, PhD

Principal Investigator

Children's National Hosptial

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

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

The Feasibility of a Pilot Intervention for Parents of Young Children Newly Diagnosed with Type 1 Diabetes. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Parental experiences of short term supported use of a do-it-yourself continuous glucose monitor (DIYrtCGM): A qualitative study. [2022]

3. England 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. [2022]

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

Learning by supporting others-experienced parents' development process when supporting other parents with a child with type 1 diabetes. [2018]

5. Norway pubmed.ncbi.nlm.nih.gov

Persistent effects of a pedagogical device targeted at prevention of severe hypoglycaemia: a randomized, controlled study. [2019]

6. Denmark pubmed.ncbi.nlm.nih.gov

Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP). [2022]

7. United States 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. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness. [2023]

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

Patient Input for Design of a Decision Support Smartphone Application for Type 1 Diabetes. [2021]

11. England pubmed.ncbi.nlm.nih.gov

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