Can Your Teen’s Time in Range Improve with Help from a Family Support Program?
By Wilson Murane
This clinical trial is currently recruiting. Families will participate in weekly sessions that focus on topics related to diabetes distress and parent-teen communication, with the hopes of improving Time in Range and lowering A1C levels in the teen with type 1 diabetes.
Clinical Trials Identifier: NCT04589689
Trial name: Insul-In This Together Program for Adolescents with Type 1 Diabetes and Their Parents (IITT)
Diabetes type: Type 1
What is the trial testing?
The study is designed for teens with type 1 diabetes and their families, to evaluate a new family-based support program. The goal is to study the relationship between diabetes management and adolescent mental health, to decrease stress related to diabetes for the entire family, and to improve glucose management in the teen. Ultimately, these researchers want to know how changes in managing stress might relate to glucose stability.
165 teens and their parents will be split into two experimental groups. The first group will participate in the program immediately, which consists of six weekly 30-minute family sessions to discuss topics related to diabetes distress and parent-teen communication (all held virtually, via Zoom). The second group will begin the same program six months into the trial.
At the beginning of the trial and at three, six, and twelve-month follow-ups, online surveys (for both teen and parent) will be given, and glucose data from the teen’s continuous glucose monitor (CGM) will be recorded. In addition to the quarterly surveys, participants will be given a brief survey after every two weekly sessions. Participants will also be asked to provide A1C levels at the start of the trial, after 6 months, and after 12-months.
What is the trial measuring?
The trial will measure a variety of outcomes in both the teens and their parents, including:
Time in Range, based on two weeks of CGM data at the six-month follow-up
Adolescent quality of life based on the Type 1 Diabetes and Life survey
Survey data on depression (for teens and parents), distress (teens), diabetes distress (parents), and parenting stress
Why is this new and important?
For many families living with type 1 diabetes, diabetes stress can pose a significant mental and emotional challenge for the parent and the teen with diabetes. It can also take a toll on the teen’s glucose levels. This study wants to validate a new support intervention program to reduce some of the negative psychological aspects of diabetes, resulting in a higher quality of life for the family and improved glucose outcomes for the teen.
Trial length: 1 year
Trial location: This trial is fully virtual so you can participate from anywhere in the US.
Are you interested?
The trial is enrolling families now! You may be eligible to join the study if your family:
Has a teenager between the ages of 12-19 who was diagnosed with type 1 diabetes at least 6 months ago and who has an A1C above 7.5%
Has at least one parent or caregiver that lives with the teen and is willing to participate
Has access to a smartphone or laptop with WiFi