N/A
N=314
Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04589689 ↗Enrolled (actual)
314
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Glucose Levels Percent Time in Target Range Based on Glucose Monitoring — 61.185; 64.542; 62.223; 64.571 percentage of time-in-range — p=0.777
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insul-In This Together (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Levels Percent Time in Target Range Based on Glucose Monitoring |
61.185; 64.542; 62.223; 64.571; 61.680; 65.908 | 0.777 |
| PRIMARY Adolescent Quality of Life |
67.902; 64.633; 67.965; 63.675; 69.523; 65.511 | 0.160 |
| SECONDARY Adolescent Depression |
2.278; 2.718; 2.411; 3.130; 2.419; 2.963 | 0.509 |
| SECONDARY Parent Depression |
4.772; 5.167; 4.099; 4.346; 4.088; 4.409 | 0.807 |
| SECONDARY Adolescent Diabetes Distress |
28.608; 32.064; 27.847; 32.219; 27.883; 30.265 | 0.076 |
| SECONDARY Parent Diabetes Distress |
43.177; 44.859; 36.405; 38.817; 36.393; 40.542 | 0.154 |
| SECONDARY Parenting Stress |
73.633; 71.256; 74.706; 71.777; 74.376; 71.865 | 0.445 |
| SECONDARY Hemoglobin A1c (HbA1c) |
7.166; 7.19; 7.260; 7.069 | 0.157 |
Summary
The "Insul-In This Together" intervention is designed for teens with Type 1 Diabetes and their parents. This study seeks to evaluate an evidence-based family intervention for teens with type 1 diabetes and their parents to offset the psychosocial and diabetes self-management risks. This information will provide a more in-depth understanding of family-based program efficacy for teens with adolescents and provide more judicious and streamlined intervention options to be offered in diabetes clinics in the future.
Eligibility Criteria
Inclusion Criteria
- Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months
- Teen subject is age 12-19 years at time of screening (no age limit for parent participants)
- Participation of at least one cohabitating parent/caregiver.
Exclusion Criteria
- Subject lacks access to a smartphone or Wi-Fi via computer
- Subject has restricted or no English proficiency
- Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study
Data sourced from ClinicalTrials.gov (NCT04589689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.