Sleep and Glycemic Control in Type 2 Diabetes Adolescents

NCT04213547 | Recruiting

• 2 other identifiers: 19-0165992T32DK063688-16
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Sleep duration (for Aim 2)

  Will assess for sleep extension throughout intervention

  13 weeks

• Hemoglobin A1c (for Aim 1)

  Aim 1 is assessing cross-sectional relationship of A1c to sleep duration

  baseline

• BMI (for Aim 1)

  Aim 1 is assessing cross-sectional relationship of BMI to sleep duration

  baseline

• Qualitative data from focus group

  Qualitative output from focus group discussion on text messages

  baseline at focus group

Secondary Outcomes (3)

• Glycemic control

  13 weeks

• Glycemic control

  13 weeks

• BMI

  13 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Loss frame sleep extension intervention

Interventions

Loss frame sleep extension intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• Aim 1 for child:
• Non-English speaking subject (as questionnaires used are validated in English)
• 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.
• Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes)
• 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.
• Oral or IV steroid treatment within the past month
• 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.
• Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep.
• Subjects with hemoglobinopathies that affect hemoglobin A1c measurement.
• Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment
• Known diagnosis of obstructive sleep apnea or other sleep disorder
• Aim 1 for Parent:
• Non-English speaking subject (as questionnaires used are validated in English)
• Parent/guardians with cognitive disorders that may affect data collection (determined on a case-by-case basis)
• Aim 2 for child:

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (7)

• Mayer-Davis EJ, Lawrence JM, Dabelea D, Divers J, Isom S, Dolan L, Imperatore G, Linder B, Marcovina S, Pettitt DJ, Pihoker C, Saydah S, Wagenknecht L; SEARCH for Diabetes in Youth Study. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Apr 13;376(15):1419-1429. doi: 10.1056/NEJMoa1610187.

  PMID: 28402773 BACKGROUND

• Cappuccio FP, Taggart FM, Kandala NB, Currie A, Peile E, Stranges S, Miller MA. Meta-analysis of short sleep duration and obesity in children and adults. Sleep. 2008 May;31(5):619-26. doi: 10.1093/sleep/31.5.619.

  PMID: 18517032 BACKGROUND

• Wheaton AG, Olsen EO, Miller GF, Croft JB. Sleep Duration and Injury-Related Risk Behaviors Among High School Students--United States, 2007-2013. MMWR Morb Mortal Wkly Rep. 2016 Apr 8;65(13):337-41. doi: 10.15585/mmwr.mm6513a1.

  PMID: 27054407 BACKGROUND

• Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28.

  PMID: 20585000 BACKGROUND

• Spiegel K, Knutson K, Leproult R, Tasali E, Van Cauter E. Sleep loss: a novel risk factor for insulin resistance and Type 2 diabetes. J Appl Physiol (1985). 2005 Nov;99(5):2008-19. doi: 10.1152/japplphysiol.00660.2005.

  PMID: 16227462 BACKGROUND

• Knutson KL, Van Cauter E, Zee P, Liu K, Lauderdale DS. Cross-sectional associations between measures of sleep and markers of glucose metabolism among subjects with and without diabetes: the Coronary Artery Risk Development in Young Adults (CARDIA) Sleep Study. Diabetes Care. 2011 May;34(5):1171-6. doi: 10.2337/dc10-1962. Epub 2011 Mar 16.

  PMID: 21411507 BACKGROUND

• Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.

  PMID: 26881417 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Talia A Hitt, MD/MPH

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Central Study Contacts

Talia Hitt, MD/MPH

CONTACT

215-590-3174; hittt@chop.edu

Beth Schwartzman

CONTACT

215-590-3174; schwartzmann@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 with text message feedback. 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 Record Dates

• First Submitted: December 26, 2019
• First Posted: December 30, 2019
• Study Start: September 16, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)