T1DAL Program for Type 1 Diabetes
(T1DAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test the T1DAL Program, a new initiative designed to help teens with type 1 diabetes (T1D) manage their weight and improve overall health. Teens with T1D often face unique challenges, such as needing to eat when not hungry to manage blood sugar, which can lead to weight issues and increase the risk of heart disease. The study will compare the new program to usual diabetes care to determine if it better supports healthy habits and prevents eating disorders. Teens who have had T1D for at least six months, have a body mass index in the higher range for their age, and live with a caregiver may be a good fit for this trial. As an unphased trial, this study offers teens a unique opportunity to contribute to innovative diabetes care solutions.
Do I have to stop taking my current medications for the T1DAL trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking a medication known to impact weight or appetite.
What prior data suggests that the T1DAL program is safe for teens with type 1 diabetes?
Research has shown that participants receive the T1DAL program positively. Previous studies indicate that it can be successfully conducted in various locations and receives favorable feedback. Participants reported feeling better overall, indicating an improvement in their health-related quality of life. These findings suggest that the T1DAL program is safe, with no significant reports of harmful effects. This should reassure teens with type 1 diabetes about its safety.12345
Why are researchers excited about this trial?
The T1DAL Program is unique because it focuses on an intensive health behavior and lifestyle treatment specifically tailored for adolescents with type 1 diabetes. Unlike standard care options, which often include insulin therapy and glucose monitoring, this program emphasizes behavioral and lifestyle changes aimed at improving diabetes management. Researchers are excited about this approach because it has the potential to empower young patients to take better control of their condition through sustainable lifestyle adjustments, which could lead to improved long-term health outcomes.
What evidence suggests that the T1DAL program could be an effective treatment for type 1 diabetes?
Research has shown that behavior-focused programs can help people with Type 1 Diabetes (T1D) enhance their quality of life, mental health, and condition management. Studies have found that intensive health behavior and lifestyle treatments (IHBLTs) effectively address childhood obesity, which is increasingly common among young people with T1D. This trial features the T1DAL program, specifically designed for teens with T1D, to improve their eating habits and diabetes management. Early results suggest that these tailored programs can lead to better diabetes control and healthier lifestyles. Participants in similar programs have reported improved condition management and overall well-being.26789
Who Is on the Research Team?
Jenny Warnick, PhD
Principal Investigator
The Miriam Hospital
Are You a Good Fit for This Trial?
This trial is for teens who have had type 1 diabetes for at least 6 months, live with a parent or caregiver, have a BMI in the top 30% for their age and sex (overweight), speak English fluently with their caregiver, and have access to a smartphone.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the T1DAL group undergo a 16-week intensive health behavior and lifestyle treatment program adapted for a type 1 diabetes population
Usual Care
Participants in the Usual Care group continue their regular endocrinology appointments
Follow-up
Participants are monitored for changes in BMI, time in glucose range, and unhealthy weight control behaviors
Open-label extension (optional)
Usual Care group participants are offered a shortened version of the T1DAL program
What Are the Treatments Tested in This Trial?
Interventions
- T1DAL Program
Trial Overview
The study compares the T1DAL program—a special 16-week lifestyle and health behavior program designed for teens with type 1 diabetes—to usual care. Teens are randomly assigned to either group. The goal is to see if T1DAL improves eating habits, mood, weight management, and diabetes control.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Adolescent intensive health behavior and lifestyle treatment adapted for a type 1 diabetes population
Adolescents continue their typical diabetes treatment management.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Miriam Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
About T1DAL
A clinical research trial for people recently diagnosed with type 1 diabetes. T1DAL is no longer accepting study participants.
Design of the type 1 diabetes and life (T1DAL) pilot and ... - PMC
Behavioral interventions for people with T1D have been shown to impact HRQOL, psychological outcomes, self-management, and glycemic outcomes [[ ...
Type 1 Diabetes Adolescents for Healthier Lifestyles Study
Those in the T1DAL group will take part in a 16-week program designed specifically for teens with T1D to improve eating habits and diabetes management. Those in ...
Type 1 Diabetes Glycemic Outcomes Are Improving
Type 1 Diabetes Glycemic Outcomes Are Improving: Real World Data of Over 80,000 People in the T1D Exchange Quality Improvement Collaborative · Related Stories.
Health-Related Quality of Life in Parents and Partners ... - PMC
This study aimed to develop and evaluate the psychometric properties of new measures of diabetes-specific HRQOL for parents and partners of people with T1D.
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diabetesjournals.org
diabetesjournals.org/diabetes/article/74/Supplement_1/299-OR/158750/299-OR-Outcomes-of-Type-1-Diabetes-and-Life-T1DAL299-OR: Outcomes of Type 1 Diabetes and Life (T1DAL ...
Conclusion: The T1DAL intervention was feasible to conduct across settings and participants were largely satisfied. Improvements in HRQOL ...
T1DAL | A clinical research trial for people recently diagnosed ...
A clinical research trial for people recently diagnosed with type 1 diabetes. T1DAL is no longer accepting study participants.
Design of the type 1 diabetes and life (T1DAL) pilot ...
This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members.
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