Sleep and Glycemic Control in Type 2 Diabetes Adolescents

Official title

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

Overview

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.

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.

Interventions

• 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 tex

Primary outcome measures

• 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]

Secondary outcome measures (3)

• Glycemic control [Time frame: 13 weeks]
• Glycemic control [Time frame: 13 weeks]
• BMI [Time frame: 13 weeks]

Eligibility criteria

Inclusion criteria

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:

1\. Parent or legal guardian of child that meets inclusion criteria for Aim 1.

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

Exclusion criteria

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:

1\. Do not own a smart phone or tablet

Focus group for child:

• Non-English speaking subject (as focus group will be conducted in English)
• Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Children's Hospital of Philadelphia — Philadelphia

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT04213547 · 19-016599 · 2T32DK063688-16

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗