Sleep and Glycemic Control in Type 2 Diabetes Adolescents

March 30, 2026 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Talia Hitt, MD/MPH
  • Phone Number: 215-590-3174
  • Email: hittt@chop.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep duration (for Aim 2)
Time Frame: 13 weeks
Will assess for sleep extension throughout intervention
13 weeks
Hemoglobin A1c (for Aim 1)
Time Frame: baseline
Aim 1 is assessing cross-sectional relationship of A1c to sleep duration
baseline
BMI (for Aim 1)
Time Frame: baseline
Aim 1 is assessing cross-sectional relationship of BMI to sleep duration
baseline
Qualitative data from focus group
Time Frame: baseline at focus group
Qualitative output from focus group discussion on text messages
baseline at focus group

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 13 weeks
Will assess for change in hemoglobin a1c throughout intervention
13 weeks
Glycemic control
Time Frame: 13 weeks
Will assess for change in continuous glucose monitor measures throughout intervention
13 weeks
BMI
Time Frame: 13 weeks
Will assess for change in body mass index (BMI) throughout intervention
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Study Director: Talia A Hitt, MD/MPH, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 26, 2019

First Submitted That Met QC Criteria

December 26, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-016599
  • 2T32DK063688-16 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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