Research on Optimizing the Use of Technology With Education

Type 1 Diabetes Clinical Trial

— ROUTE-T1D  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05564481
• Other study ID #: Pro00016314
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2024
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 30, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Intervention
• Continuous Glucose Monitoring
• Diabetes Mellitus, Type 1
• Parent-Child Relations
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	hemoglobin A1c (HbA1c)	Baseline
Primary	Glycemic control	hemoglobin A1c (HbA1c)	3 months post randomization
Primary	Glycemic control	hemoglobin A1c (HbA1c)	6 months post randomization
Primary	Glycemic control	hemoglobin A1c (HbA1c)	12 months post randomization
Primary	glycemic variability	Using 14-30 days of CGM data	Baseline
Primary	glycemic variability	Using 14-30 days of CGM data	3 months post randomization
Primary	glycemic variability	Using 14-30 days of CGM data	6 months post randomization
Primary	glycemic variability	Using 14-30 days of CGM data	12 months post randomization
Secondary	Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	Baseline
Secondary	Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	3 months post randomization
Secondary	Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	6 months post randomization
Secondary	Family Conflict	The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict	12 months post randomization
Secondary	Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	Baseline
Secondary	Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	3 months post randomization
Secondary	Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	6 months post randomization
Secondary	Diabetes Distress	Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress	12 months post randomization
Secondary	CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	Baseline
Secondary	CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	3 months post randomization
Secondary	CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	6 months post randomization
Secondary	CGM benefits and burdens	Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM	12 month post randomization
Secondary	CGM use	Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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