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Sleep Extension Intervention for Type 2 Diabetes Adolescents
N/A
Recruiting
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether more sleep leads to better blood sugar control in teenagers with Type 2 Diabetes, and whether a reward system can help them get more sleep.
Who is the study for?
Adolescents aged 12-20 with Type 2 Diabetes, HbA1c ≤ 10%, sleeping less than 8 hours per night, and a low risk of sleep apnea can join. They must be on T2DM treatments like diet changes or medications, have good treatment adherence, and own a smartphone. Those with recent steroid use, other serious health issues affecting sleep, non-English speakers, certain hemoglobinopathies or behavioral disorders are excluded.
What is being tested?
The trial is testing if an incentive-based program encouraging more sleep can improve blood sugar control in teens with Type 2 Diabetes who don't get enough sleep. It involves tracking their sleep for two weeks and then seeing if rewards linked to achieving better sleep help them rest more and manage their diabetes better.
What are the potential side effects?
Since this intervention focuses on behavior modification through incentives rather than medication or medical procedures, side effects are minimal but may include potential stress from changing routines or disappointment from not meeting goals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
BMI (for Aim 1)
Hemoglobin A1c (for Aim 1)
Qualitative data from focus group
+1 moreSecondary study objectives
BMI
Glycemic control
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,472,944 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,449 Previous Clinical Trials
4,332,377 Total Patients Enrolled
Talia A Hitt, MD/MPHStudy DirectorChildren's Hospital of Philadelphia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently managing my type 2 diabetes with diet, Metformin, or insulin.I am not pregnant, as pregnancy can affect sleep patterns.You sleep less than 8 hours per night on average, as measured by a special device called actigraphy.I follow my treatment plan at least 80% of the time.I am unlikely to have sleep apnea, based on a sleep survey.I am not living in an institution which affects my sleep patterns.Your HbA1c level (a measure of blood sugar over time) should be 10% or less. Having higher levels may mean you have trouble sticking to the treatment plan.I have a blood condition that affects my hemoglobin A1c levels.I have a condition like hyperthyroidism or chronic pain that affects my sleep.I can participate in studies, answer questionnaires, and wear devices as needed.I have taken steroids by mouth or IV in the last month.I am not fluent in English.I am between 12 and 20 years old.I have a form of diabetes that is not type 2.I couldn't get a hemoglobin A1c test in the clinic on the day I was recruited.I have a form of diabetes that is not Type 1.I have type 2 diabetes without an autoimmune cause.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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