Clinical trial NCT05564481: Research on Optimizing the Use of Technology With Education
Official title: Optimizing Technology Uptake and Use in Hard to Reach Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Continuous Glucose Monitoring
Behavioral Intervention
Parent-Child Relations
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: wait-list control; all participants receive intervention- randomized to start immediately or 6 months after CGM start
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control
timeFrame: Baseline
measure: Glycemic control
timeFrame: 3 months post randomization
measure: Glycemic control
timeFrame: 6 months post randomization
measure: Glycemic control
timeFrame: 12 months post randomization
measure: glycemic variability
timeFrame: Baseline
measure: glycemic variability
timeFrame: 3 months post randomization
measure: glycemic variability
timeFrame: 6 months post randomization
measure: glycemic variability
timeFrame: 12 months post randomization
Secondary outcomes:
measure: Family Conflict
timeFrame: Baseline
measure: Family Conflict
timeFrame: 3 months post randomization
measure: Family Conflict
timeFrame: 6 months post randomization
measure: Family Conflict
timeFrame: 12 months post randomization
measure: Diabetes Distress
timeFrame: Baseline
measure: Diabetes Distress
timeFrame: 3 months post randomization
measure: Diabetes Distress
timeFrame: 6 months post randomization
measure: Diabetes Distress
timeFrame: 12 months post randomization
measure: CGM benefits and burdens
timeFrame: Baseline
measure: CGM benefits and burdens
timeFrame: 3 months post randomization
measure: CGM benefits and burdens
timeFrame: 6 months post randomization
measure: CGM benefits and burdens
timeFrame: 12 month post randomization
measure: CGM use
timeFrame: Baseline
measure: CGM use
timeFrame: 3 months post randomization
measure: CGM use
timeFrame: 6 months post randomization
measure: CGM use
timeFrame: 12 months post randomization
measure: Diabetes self-management
timeFrame: Baseline
measure: Diabetes self-management
timeFrame: 3 months post randomization
measure: Diabetes self-management
timeFrame: 6 months post randomization
measure: Diabetes self-management
timeFrame: 12 months post randomization
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Research Institute
state: District of Columbia
Study officials:
affiliation: Children's National Hosptial
name: Randi Streisand, PhD
role: PRINCIPAL_INVESTIGATOR
References: