Sleep and Glycemic Control in Type 2 Diabetes Adolescents

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04213547
• Other study ID #: 19-016599
• Secondary ID: 2T32DK063688-16
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital of Philadelphia
• Contact: Talia Hitt, MD/MPH
• Phone: 215-590-3174
• Email: hittt[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep duration (for Aim 2)	Will assess for sleep extension throughout intervention	13 weeks
Primary	Hemoglobin A1c (for Aim 1)	Aim 1 is assessing cross-sectional relationship of A1c to sleep duration	baseline
Primary	BMI (for Aim 1)	Aim 1 is assessing cross-sectional relationship of BMI to sleep duration	baseline
Primary	Qualitative data from focus group	Qualitative output from focus group discussion on text messages	baseline at focus group
Secondary	Glycemic control	Will assess for change in hemoglobin a1c throughout intervention	13 weeks
Secondary	Glycemic control	Will assess for change in continuous glucose monitor measures throughout intervention	13 weeks
Secondary	BMI	Will assess for change in body mass index (BMI) throughout intervention	13 weeks