Research on Optimizing the Use of Technology With Education (ROUTE-T1D)

July 1, 2025 updated by: Randi Streisand, Children's National Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate 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).
Behavioral: diabetes education and parent coaching support
Intervention sessions will include parent/child discussion about barriers to CGM use, review of CGM data, problem solving, and working as a team.
Active Comparator: Wait-list/delayed 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).
Behavioral: diabetes education and parent coaching support
Intervention sessions will include parent/child discussion about barriers to CGM use, review of CGM data, problem solving, and working as a team.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Baseline
hemoglobin A1c (HbA1c)
Baseline
Glycemic control
Time Frame: 3 months post randomization
hemoglobin A1c (HbA1c)
3 months post randomization
Glycemic control
Time Frame: 6 months post randomization
hemoglobin A1c (HbA1c)
6 months post randomization
Glycemic control
Time Frame: 12 months post randomization
hemoglobin A1c (HbA1c)
12 months post randomization
glycemic variability
Time Frame: Baseline
Using 14-30 days of CGM data
Baseline
glycemic variability
Time Frame: 3 months post randomization
Using 14-30 days of CGM data
3 months post randomization
glycemic variability
Time Frame: 6 months post randomization
Using 14-30 days of CGM data
6 months post randomization
glycemic variability
Time Frame: 12 months post randomization
Using 14-30 days of CGM data
12 months post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Family Conflict
Time Frame: Baseline
The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict
Baseline
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 months post randomization
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
6 months post randomization
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
12 months post randomization
Diabetes Distress
Time Frame: Baseline
Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress
Baseline
Diabetes Distress
Time Frame: 3 months post randomization
Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress
3 months post randomization
Diabetes Distress
Time Frame: 6 months post randomization
Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress
6 months post randomization
Diabetes Distress
Time Frame: 12 months post randomization
Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress
12 months post randomization
CGM benefits and burdens
Time Frame: Baseline
Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM
Baseline
CGM benefits and burdens
Time Frame: 3 months post randomization
Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM
3 months post randomization
CGM benefits and burdens
Time Frame: 6 months post randomization
Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM
6 months post randomization
CGM benefits and burdens
Time Frame: 12 month post randomization
Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM
12 month post randomization
CGM use
Time Frame: Baseline
Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM.
Baseline
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.
3 months post randomization
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.
6 months post randomization
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.
12 months post randomization
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
Baseline
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
3 months post randomization
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
6 months post randomization
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
12 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's National Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Randi Streisand, PhD, Children's National Hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00016314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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