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RECRUITING

NCT04213547

Sleep and Glycemic Control in Type 2 Diabetes Adolescents

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 20 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-09-16

Completion Date

2026-06-01

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Type 2 Diabetes

Interventions

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.

Inclusion Criteria: Aim 1 for child: 1. Subjects age 12-20 2. Diagnosed with T2DM by standard laboratory criteria without pancreatic autoimmunity 3. Low probability of obstructive sleep apnea (OSA) assessed via validated sleep survey 4. Subjects will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and/or insulin) 5. 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: 1. Completed Aim 1 evaluation 2. Average sleep duration \< 8 hours per night as determined by actigraphy in Aim 1 3. HbA1c ≤ 10% as HbA1c \>10 correlates to poor adherence 4. Adherence \> 80% Focus group for child: 1. Subjects aged 12-20 2. Diagnosed with type 2 diabetes without pancreatic autoimmunity Exclusion Criteria: Aim 1 for child: 1. Non-English speaking subject (as questionnaires used are validated in English) 2. Institutionalized patients as sleep duration will not be of their own accord, and therefore is not generalizable to the rest of the adolescent T2DM population. 3. Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes) 4. Behavioral disorders that may affect data collection (e.g. autism spectrum disorder) will be determined on a case-by-case basis. These include patients that are unable to answer questionnaires on their own, participate in a sleep diary, wear devices and/or understand incentives. 5. Oral or IV steroid treatment within the past month 6. Females with known pregnancies as these patients will not be generalizable to the rest of the adolescent T2DM population and pregnancy may alter sleep duration. 7. Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep. 8. Subjects with hemoglobinopathies that affect hemoglobin A1c measurement. 9. Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment 10. Known diagnosis of obstructive sleep apnea or other sleep disorder Aim 1 for Parent: 1. Non-English speaking subject (as questionnaires used are validated in English) 2. Parent/guardians with cognitive disorders that may affect data collection (determined on a case-by-case basis) Aim 2 for child: 1\. Do not own a smart phone or tablet Focus group for child: 1. Non-English speaking subject (as focus group will be conducted in English) 2. Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States