Actively Recruiting
Sleep and Glycemic Control in Type 2 Diabetes Adolescents
Led by Children's Hospital of Philadelphia · Updated on 2026-04-03
90
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective is to determine the cross-sectional relationship between sleep duration (as measured by 14 days of actigraphy) and glycemic control in an adolescent Type 2 Diabetes (T2DM) cohort (age 12-20y, n=67). A secondary objective is to determine if a loss-framed incentive for achieving sleep goals can increase sleep duration in 15 adolescent patients diagnosed with T2DM with insufficient sleep. Another secondary objective is to test if increasing sleep duration leads to improved glycemic control in 15 adolescents with T2DM identified in Aim 1 as having \<8 hr sleep/evening. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
CONDITIONS
Official Title
Sleep and Glycemic Control in Type 2 Diabetes Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 to 20 years
- Diagnosed with Type 2 Diabetes by standard laboratory criteria without pancreatic autoimmunity
- Low probability of obstructive sleep apnea assessed by validated sleep survey
- Receiving treatment for Type 2 Diabetes such as diet modification, Metformin, or insulin
- Parental or guardian permission and child assent
- Completed Aim 1 evaluation (for Aim 2 intervention)
- Average sleep duration less than 8 hours per night as measured by actigraphy (for Aim 2 intervention)
- Hemoglobin A1c 10% or less (for Aim 2 intervention)
- Adherence greater than 80% (for Aim 2 intervention)
- Parent or legal guardian of child who meets inclusion criteria (for Aim 1 parent participation)
- Subjects aged 12 to 20 years diagnosed with Type 2 Diabetes without pancreatic autoimmunity (for focus group)
You will not qualify if you...
- Non-English speaking participants (questionnaires and focus group conducted in English)
- Institutionalized patients
- Diagnosis of other types of Diabetes Mellitus such as Type 1 Diabetes
- Behavioral disorders that affect data collection, including inability to answer questionnaires, participate in sleep diary, wear devices, or understand incentives
- Use of oral or IV steroid treatment within the past month
- Known pregnancy in female participants
- Known hyperthyroidism, pain syndrome, or serious medical conditions affecting sleep
- Hemoglobinopathies affecting hemoglobin A1c measurement
- Unable to obtain point-of-care hemoglobin A1c on recruitment date
- Known diagnosis of obstructive sleep apnea or other sleep disorders
- Parent or guardian with cognitive disorders affecting data collection
- Do not own a smartphone or tablet (for Aim 2 intervention participation)
- Lack of access to a computer, tablet, or smartphone for video conferencing (for focus group participation)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
T
Talia Hitt, MD/MPH
CONTACT
B
Beth Schwartzman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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