Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT04213547
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.
Interested in participating?
Request Info12 year–20 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Aim 1 will be a cross-sectional study design utilizing actigraphy watch devices to estimate sleep duration. Participants will be recruited either before or after a routine outpatient clinic visit and asked to complete intake questionnaires. They will then be provided an actigraphy watch device which will be worn for 14 days to estimate sleep duration, and Libre continuous glucose monitor (CGM) to estimate glycemic control. After their visit, clinical data will be extracted from the electronic medical record.
Aim 2 will be an interventional study design utilizing Fitbit 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aim 1 for child:
Aim 1 for parent:
Aim 2 for child:
Focus group for child:
Exclusion criteria
Aim 1 for child:
Aim 1 for Parent:
Aim 2 for child:
Focus group for child:
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.
Time frame: 13 weeks
Will assess for sleep extension throughout intervention
Time frame: baseline
Aim 1 is assessing cross-sectional relationship of A1c to sleep duration
Time frame: baseline
Aim 1 is assessing cross-sectional relationship of BMI to sleep duration
Time frame: baseline at focus group
Qualitative output from focus group discussion on text messages
Time frame: 13 weeks
Will assess for change in hemoglobin a1c throughout intervention
Time frame: 13 weeks
Will assess for change in continuous glucose monitor measures throughout intervention
Time frame: 13 weeks
Will assess for change in body mass index (BMI) throughout intervention
Contact information is provided by the study sponsor or research team.
Beth Schwartzman
CONTACT
Talia Hitt, MD/MPH
CONTACT
Children's Hospital of Philadelphia
Other
Sleep Duration and Glycemic Control in Adolescents With Type 2 Diabetes Mellitus
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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