Research on Optimizing the Use of Technology With Education

NCT05564481 | Active Not Recruiting

• 1 other identifier: Pro00016314
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Continuous Glucose Monitoring; Behavioral Intervention; Parent-Child Relations

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (20)

• Family Conflict

  Baseline

• Family Conflict

  3 months post randomization

• Family Conflict

  6 months post randomization

• Family Conflict

  12 months post randomization

• Diabetes Distress

  Baseline

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Wait-list/delayed intervention

ACTIVE COMPARATOR

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

Interventions

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.

Immediate intervention; Wait-list/delayed intervention

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Research Institute

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Randi Streisand, PhD

  Children's National Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: a research assistant blind to condition of participant will complete outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psych/Behavioral Hlth

Model Details: wait-list control; all participants receive intervention- randomized to start immediately or 6 months after CGM start

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: October 3, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)