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

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: Active, not recruiting
• Conditions: Type 1 Diabetes; Parent-Child Relations; Continuous Glucose Monitoring; Behavioral Intervention
• Intervention / Treatment: Behavioral: diabetes education and parent coaching support

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Straton; Phone Number: 202-476-5360; Email: estraton@childrensnational.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Glycemic control	hemoglobin A1c (HbA1c)	Baseline
Glycemic control	hemoglobin A1c (HbA1c)	3 months post randomization
Glycemic control	hemoglobin A1c (HbA1c)	6 months post randomization
Glycemic control	hemoglobin A1c (HbA1c)	12 months post randomization
glycemic variability	Using 14-30 days of CGM data	Baseline
glycemic variability	Using 14-30 days of CGM data	3 months post randomization
glycemic variability	Using 14-30 days of CGM data	6 months post randomization
glycemic variability	Using 14-30 days of CGM data	12 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	Baseline
Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	3 months post randomization
Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	6 months post randomization
Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	12 months post randomization
Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	Baseline
Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	3 months post randomization
Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	6 months post randomization
Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	12 months post randomization
CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	Baseline
CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	3 months post randomization
CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	6 months post randomization
CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	12 month post randomization
CGM use	Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM.	Baseline
CGM use	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	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	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	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	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	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	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

• Sponsor: Children's National Research Institute
• Investigators: Principal Investigator: Randi Streisand, PhD, Children's National Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID 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