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New treatment option for Type 1 Diabetes (T1D)
Official title Type 1 Diabetes REst for Metabolic Health
ClinicalTrials.gov ID: NCT06627504
What this study is testing
- What it's testing
- Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 19
You may be able to join if
- High school students between the ages of 14-19 years;
- Diagnosed with T1D for ≥1 year;
- Using an insulin pump or other automated insulin delivery system;
- Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
- With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
You likely can't join if
- Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep...
- Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
- Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
- HbA1c ≥12%;
- Severe illness or DKA within 60 days;
- IQ\<70 or severe mental illness impacting sleep or ability to participate in the study;
See the full eligibility criteria
- High school students between the ages of 14-19 years;
- Diagnosed with T1D for ≥1 year;
- Using an insulin pump or other automated insulin delivery system;
- Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
- With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
- Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
- Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure
- Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
- Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
- HbA1c ≥12%;
- Severe illness or DKA within 60 days;
- IQ\<70 or severe mental illness impacting sleep or ability to participate in the study;
- Night-shift employment or other obligations that would preclude adherence to the intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 19 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.