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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BMI (for Aim 1)
Hemoglobin A1c (for Aim 1)
Qualitative data from focus group
+1 more
Secondary outcome measures
BMI
Glycemic control

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
708 Previous Clinical Trials
8,580,969 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,502 Total Patients Enrolled
Talia A Hitt, MD/MPHStudy DirectorChildren's Hospital of Philadelphia

Media Library

Loss frame sleep extension intervention Clinical Trial Eligibility Overview. Trial Name: NCT04213547 — N/A
Type 2 Diabetes Research Study Groups: Intervention
Type 2 Diabetes Clinical Trial 2023: Loss frame sleep extension intervention Highlights & Side Effects. Trial Name: NCT04213547 — N/A
Loss frame sleep extension intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04213547 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for enrolment in this experiment?

"Affirmative. According to information located on clinicaltrials.gov, this research is currently recruiting participants. The trial was first published on September 16th of 2020 and modified most recently in March 2022; 15 patients are being sought at a single site for the study's duration."

Answered by AI

What is the participant count of this research endeavor?

"Affirmative. Documentation housed on clinicaltrials.gov reveals that this research endeavour, which was first announced on September 16th 2020, is currently looking for volunteers. 15 individuals across 1 medical centre need to be enrolled in the trial."

Answered by AI

Does this trial encompass participants who exceed thirty years of age?

"The eligibility for this investigation necessitates that patients are between 12 to 20 years old. Specifically, 192 trials require those under 18 and 1103 studies focus on adults over 65."

Answered by AI

What is the criteria for enrollment in this medical research study?

"This study is open to 15 adolescents living with type 2 diabetes mellitus. To be included, minors must have been diagnosed using laboratory tests and have a low risk of obstructive sleep apnea as assessed by validated surveys. Participants are also required to report an average nightly sleep duration under 8 hours, HbA1c below 10%, and medication adherence above 80%."

Answered by AI
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~33 spots leftby May 2026