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Active, Not Recruiting

NCT Number: NCT05564481

Research on Optimizing the Use of Technology With Education

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Research Institute

Washington D.C., District of Columbia, 20010, United States

About this study

Young adolescents (ages 10-15) with type 1 diabetes (T1D) are at high risk for deterioration of glycemic control and relatedly poor overall T1D self-management. Continuous glucose monitors (CGM) provide real-time indicators of glucose levels and alert users to hypoglycemia and hyperglycemia. Consistent, informed use of CGM has the potential to improve glycemic control and related T1D health outcomes. However, adolescents with T1D are the least likely age group to utilize CGM and significant health disparities exist in access to and use of CGM among youth from racial and ethnic minority backgrounds and youth with public insurance. Adolescent CGM users also continue to evidence A1c levels above recommended targets, potentially due challenges related to perceived CGM burden and related family functioning. Novel, developmentally targeted interventions delivered early in adolescence could promote optimal uptake and use of CGM and reduce psychosocial barriers to sustained use but must be evaluated in rigorous pilot trials that attend to health disparities. The current study proposes to evaluate an innovative behavioral intervention that utilizes certified diabetes care and education specialists (CDCES) to teach problem-solving and communication skills around CGM data and use, targeting adolescent-parent T1D interactions related to glucose data, individualized CGM challenges, and weekly adolescent-parent joint review of CGM reports. The intervention also addresses HCP knowledge of health disparities in diabetes technology through interactive education, and boosts family support through connection with peer parent consultants. This study aims to evaluate the preliminary efficacy of the behavioral intervention to enhance CGM use and resulting T1D health outcomes. Sixty adolescents and their parents will be recruited for this pilot randomized trial, randomly assigned to either an immediate intervention group or a delayed intervention group serving as a standard care comparison. Intervention content will be delivered via 3 telemedicine sessions with adolescents and a parent and supported by connection with a peer parent consultant. Medical and psychosocial data (including A1c, CGM indicators, CGM burdens and benefits, diabetes distress, and diabetes-related family conflict) will be collected from adolescents and a parent at baseline and three follow-up time points across the first year after CGM initiation. The investigators will employ quantitative and qualitative analyses to evaluate intervention feasibility, acceptability, and impact. Enhancing CGM access and use at this key developmental juncture provides an excellent opportunity for tailored support and problem-solving, resulting in potentially lasting improvement in diabetes self-management. Results of this pilot trial will directly inform a multi-site randomized clinical trial to evaluate efficacy, with the long term goal of identifying effective behavioral strategies that can be integrated into routine diabetes education and care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 10-15 years old
  • Type 1 diabetes
  • Type 1 diabetes diagnosis ≥ 6 months \\
  • Starting a continuous glucose monitor for the first time or restarting after ≥ 1 year

Exclusion criteria

  • Younger than 10, older than 15
  • Diagnosed less than 6 months
  • Already using CGM or has used within last year
  • Other major medical condition such as cancer, cystic fibrosis

Treatment and study plan

diabetes education and parent coaching support

Behavioral

Intervention sessions will include parent/child discussion about barriers to CGM use, review of CGM data, problem solving, and working as a team.

Primary outcomes

  1. Glycemic control

    Time frame: Baseline

    hemoglobin A1c (HbA1c)

  2. Glycemic control

    Time frame: 3 months post randomization

    hemoglobin A1c (HbA1c)

  3. Glycemic control

    Time frame: 6 months post randomization

    hemoglobin A1c (HbA1c)

  4. Glycemic control

    Time frame: 12 months post randomization

    hemoglobin A1c (HbA1c)

  5. glycemic variability

    Time frame: Baseline

    Using 14-30 days of CGM data

  6. glycemic variability

    Time frame: 3 months post randomization

    Using 14-30 days of CGM data

  7. glycemic variability

    Time frame: 6 months post randomization

    Using 14-30 days of CGM data

  8. glycemic variability

    Time frame: 12 months post randomization

    Using 14-30 days of CGM data

Secondary outcomes

  1. Family Conflict

    Time frame: Baseline

    The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict

  2. Family Conflict

    Time frame: 3 months post randomization

    The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict

  3. Family Conflict

    Time frame: 6 months post randomization

    The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict

  4. Family Conflict

    Time frame: 12 months post randomization

    The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict

  5. Diabetes Distress

    Time frame: Baseline

    Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress

  6. Diabetes Distress

    Time frame: 3 months post randomization

    Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress

  7. Diabetes Distress

    Time frame: 6 months post randomization

    Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress

  8. Diabetes Distress

    Time frame: 12 months post randomization

    Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress

  9. CGM benefits and burdens

    Time frame: Baseline

    Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM

  10. CGM benefits and burdens

    Time frame: 3 months post randomization

    Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM

  11. CGM benefits and burdens

    Time frame: 6 months post randomization

    Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM

  12. CGM benefits and burdens

    Time frame: 12 month post randomization

    Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM

  13. CGM use

    Time frame: Baseline

    Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM.

  14. CGM use

    Time frame: 3 months post randomization

    Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM.

  15. CGM use

    Time frame: 6 months post randomization

    Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM.

  16. CGM use

    Time frame: 12 months post randomization

    Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM.

  17. Diabetes self-management

    Time frame: Baseline

    The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.

    Scored 0-100 with higher scores indicating higher adherence to diabetes management

  18. Diabetes self-management

    Time frame: 3 months post randomization

    The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.

    Scored 0-100 with higher scores indicating higher adherence to diabetes management

  19. Diabetes self-management

    Time frame: 6 months post randomization

    The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.

    Scored 0-100 with higher scores indicating higher adherence to diabetes management

  20. Diabetes self-management

    Time frame: 12 months post randomization

    The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.

    Scored 0-100 with higher scores indicating higher adherence to diabetes management

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

Optimizing Technology Uptake and Use in Hard to Reach Adolescents With Type 1 Diabetes

Acronym: ROUTE-T1D

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Oct 3, 2022
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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