RecruitingNot ApplicableNCT04213547

Sleep and Glycemic Control in Type 2 Diabetes Adolescents

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


Sponsor

Children's Hospital of Philadelphia

Enrollment

90 participants

Start Date

Sep 16, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the relationship between sleep duration and blood sugar control in teenagers and young adults with Type 2 diabetes, and whether improving sleep can lead to better diabetes management. **You may be eligible if...** - You are 12 to 20 years old - You have been diagnosed with Type 2 diabetes (not Type 1) - Your blood sugar is somewhat controlled (HbA1c at or below 10%) - You are getting less than 8 hours of sleep per night on average (for the sleep intervention phase) - Parents or guardians of eligible children are also invited to participate **You may NOT be eligible if...** - You have Type 1 diabetes or autoimmune diabetes - You are suspected of having obstructive sleep apnea - Your adherence to treatment is poor - You are unwilling to participate Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLoss 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.


Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT04213547


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