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Sleep and Glycemic Control in Type 2 Diabetes Adolescents

Primary Purpose

Type 2 Diabetes

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Loss frame sleep extension intervention

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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) 5 Average sleep duration < 8 hours per night as determined by actigraphy in Aim 1

6. HbA1c ≤ 10% as HbA1c >10 correlates to poor adherence 7. Adherence > 80%

Exclusion Criteria:

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 2 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.
Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes)
Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment
Do not own a smart phone or tablet device

Sites / Locations

Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Sleep duration

Will assess for sleep extension throughout intervention

Secondary Outcome Measures

Glycemic control

Will assess for change in hemoglobin a1c throughout intervention

Glycemic control

Will assess for change in continuous glucose monitor measures throughout intervention

BMI

Will assess for change in body mass index (BMI) throughout intervention

Full Information

NCT ID

NCT04213547

First Posted

December 26, 2019

Last Updated

February 10, 2023

Sponsor

Children's Hospital of Philadelphia

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04213547

Brief Title

Sleep and Glycemic Control in Type 2 Diabetes Adolescents

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 16, 2020 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Loss frame sleep extension intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sleep duration

Description

Will assess for sleep extension throughout intervention

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Glycemic control

Description

Will assess for change in hemoglobin a1c throughout intervention

Time Frame

13 weeks

Title

Glycemic control

Description

Will assess for change in continuous glucose monitor measures throughout intervention

Time Frame

13 weeks

Title

BMI

Description

Will assess for change in body mass index (BMI) throughout intervention

Time Frame

13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 5 Average sleep duration < 8 hours per night as determined by actigraphy in Aim 1 6. HbA1c ≤ 10% as HbA1c >10 correlates to poor adherence 7. Adherence > 80% Exclusion Criteria: 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 2 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. Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes) Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment Do not own a smart phone or tablet device

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Talia A Hitt, MD/MPH

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Study Director

Facility Information:

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28402773

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.

Results Reference

background

PubMed Identifier

18517032

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.

Results Reference

background

PubMed Identifier

27054407

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.

Results Reference

background

PubMed Identifier

20585000

Citation

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.

Results Reference

background

PubMed Identifier

16227462

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.

Results Reference

background

PubMed Identifier

21411507

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.

Results Reference

background

PubMed Identifier

26881417

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.

Results Reference

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Sleep and Glycemic Control in Type 2 Diabetes Adolescents

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