NCT04213547

Sleep and Glycemic Control in Type 2 Diabetes Adolescents

Sleep Duration and Glycemic Control in Adolescents With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-16
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2019-12-30
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States