An interventional study of Loss frame sleep extension intervention in Type 2 Diabetes, sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 12 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Supportive care
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.
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.
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
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Aim 1 for child:
Aim 1 for parent:
1. Parent or legal guardian of child that meets inclusion criteria for Aim 1.
Aim 2 for child:
Focus group for child:
Exclusion Criteria:
Aim 1 for child:
Aim 1 for Parent:
Aim 2 for child:
1. Do not own a smart phone or tablet
Focus group for child:
This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.
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.
Sleep duration (for Aim 2)
Will assess for sleep extension throughout intervention
Time frame: 13 weeks
Hemoglobin A1c (for Aim 1)
Aim 1 is assessing cross-sectional relationship of A1c to sleep duration
Time frame: baseline
BMI (for Aim 1)
Aim 1 is assessing cross-sectional relationship of BMI to sleep duration
Time frame: baseline
Qualitative data from focus group
Qualitative output from focus group discussion on text messages
Time frame: baseline at focus group
Glycemic control
Will assess for change in hemoglobin a1c throughout intervention
Time frame: 13 weeks
Glycemic control
Will assess for change in continuous glucose monitor measures throughout intervention
Time frame: 13 weeks
BMI
Will assess for change in body mass index (BMI) throughout intervention
Time frame: 13 weeks
Plan to share: No
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Children's Hospital of Philadelphia