RECRUITING

Sleep and Glycemic Control in Type 2 Diabetes Adolescents

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Conditions

Type 2 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-09-16
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04213547

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.

Ages Eligible for Study:12 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects age 12-20
  2. 2. Diagnosed with T2DM by standard laboratory criteria without pancreatic autoimmunity
  3. 3. Low probability of obstructive sleep apnea (OSA) assessed via validated sleep survey
  4. 4. Subjects will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and/or insulin)
  5. 5. Parental/guardian permission and child assent
  6. 1. Parent or legal guardian of child that meets inclusion criteria for Aim 1.
  7. 1. Completed Aim 1 evaluation
  8. 2. Average sleep duration \< 8 hours per night as determined by actigraphy in Aim 1
  9. 3. HbA1c ≤ 10% as HbA1c \>10 correlates to poor adherence
  10. 4. Adherence \> 80%
  11. 1. Subjects aged 12-20
  12. 2. Diagnosed with type 2 diabetes without pancreatic autoimmunity
  1. 1. Non-English speaking subject (as questionnaires used are validated in English)
  2. 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. 3. Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes)
  4. 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. 5. Oral or IV steroid treatment within the past month
  6. 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. 7. Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep.
  8. 8. Subjects with hemoglobinopathies that affect hemoglobin A1c measurement.
  9. 9. Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment
  10. 10. Known diagnosis of obstructive sleep apnea or other sleep disorder
  11. 1. Non-English speaking subject (as questionnaires used are validated in English)
  12. 2. Parent/guardians with cognitive disorders that may affect data collection (determined on a case-by-case basis)
  13. 1. Do not own a smart phone or tablet
  14. 1. Non-English speaking subject (as focus group will be conducted in English)
  15. 2. Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing

Contacts and Locations

Study Contact

Talia Hitt, MD/MPH
CONTACT
215-590-3174
hittt@chop.edu
Beth Schwartzman
CONTACT
215-590-3174
schwartzmann@chop.edu

Principal Investigator

Talia A Hitt, MD/MPH
STUDY_DIRECTOR
Children's Hospital of Philadelphia

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Talia A Hitt, MD/MPH, STUDY_DIRECTOR, Children's Hospital of Philadelphia

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 Registration Dates

Study Start Date2020-09-16
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2020-09-16
Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Type 2 Diabetes