NCT04213547 · Children's Hospital of Philadelphia
Sleep and Glycemic Control in Type 2 Diabetes Adolescents
What this study 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) group of participants (age 12-20y, n=67).
View original scientific description
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.
Interventions
BEHAVIORAL
Loss frame sleep extension intervention
Aim 2 will be an interventional study design utilizing Fitbit and text messaging to perform a loss-framed incentive intervention designed to motivate participants to increase their sleep duration. Glycemic control will be measured via laboratory testing of hemoglobin A1c and Libre continuous glucose monitoring (CGM) for 2 weeks pre- and post-intervention. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
Primary outcome measures
Sleep duration (for Aim 2)
Time frame: 13 weeks
Will assess for sleep extension throughout intervention
Hemoglobin A1c (for Aim 1)
Time frame: baseline
Aim 1 is assessing cross-sectional relationship of A1c to sleep duration
BMI (for Aim 1)
Time frame: baseline
Aim 1 is assessing cross-sectional relationship of BMI to sleep duration
Qualitative data from focus group
Time frame: baseline at focus group
Qualitative output from focus group discussion on text messages
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aim 1 for child:
- Subjects age 12-20
- Diagnosed with T2DM by standard laboratory criteria without pancreatic autoimmunity
- Low probability of obstructive sleep apnea (OSA) assessed via validated sleep survey
- Subjects will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and/or insulin)
- Parental/guardian permission and child assent Aim 1 for parent: 1\. Parent or legal guardian of child that meets inclusion criteria for Aim 1. Aim 2 for child:
- Completed Aim 1 evaluation
- Average sleep duration \< 8 hours per night as determined by actigraphy in Aim 1
- HbA1c ≤ 10% as HbA1c \>10 correlates to poor adherence
- Adherence \> 80% Focus group for child:
- Subjects aged 12-20
- Diagnosed with type 2 diabetes without pancreatic autoimmunity
Exclusion criteria
- Aim 1 for child:
- Non-English speaking subject (as questionnaires used are validated in English)
- Institutionalized patients as sleep duration will not be of their own accord, and therefore is not generalizable to the rest of the adolescent T2DM population.
- Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes)
- Behavioral disorders that may affect data collection (e.g. autism spectrum disorder) will be determined on a case-by-case basis. These include patients that are unable to answer questionnaires on their own, participate in a sleep diary, wear devices and/or understand incentives.
- Oral or IV steroid treatment within the past month
- Females with known pregnancies as these patients will not be generalizable to the rest of the adolescent T2DM population and pregnancy may alter sleep duration.
- Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep.
- Subjects with hemoglobinopathies that affect hemoglobin A1c measurement.
- Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment
- Known diagnosis of obstructive sleep apnea or other sleep disorder Aim 1 for Parent:
- Non-English speaking subject (as questionnaires used are validated in English)
- Parent/guardians with cognitive disorders that may affect data collection (determined on a case-by-case basis) Aim 2 for child: 1\. Do not own a smart phone or tablet Focus group for child:
- Non-English speaking subject (as focus group will be conducted in English)
- Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing
Where
- Philadelphia, Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations