Recruiting

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT04213547

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 12 - 20

Healthy Volunteers: Not accepted

Interventions

Loss frame sleep extension intervention

Study Details

Brief 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.

Conditions

Type 2 Diabetes

Study ID

NCT04213547

Start date

Sep 16, 2020

Status verified date

Jun, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 20

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.

Interventions

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.

Primary outcome measure

  • Sleep duration (for Aim 2) [ Time Frame: 13 weeks ]
  • Hemoglobin A1c (for Aim 1) [ Time Frame: baseline ]
  • BMI (for Aim 1) [ Time Frame: baseline ]
  • Qualitative data from focus group [ Time Frame: baseline at focus group ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-06-29.