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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 20
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Talia Hitt, MD/MPH
hittt@chop.edu
215-590-3174
Backup
Beth Schwartzman
schwartzmann@chop.edu
215-590-3174
Time Frame
Start Date: 2020-09-16
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 90
Treatments
Experimental: Intervention
This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Children's Hospital of Philadelphia

This content was sourced from clinicaltrials.gov