Sleep and Glycemic Control in Type 2 Diabetes Adolescents

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Loss frame sleep extension intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration. | Behavioral: Loss frame sleep extension intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep duration | Will assess for sleep extension throughout intervention | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Will assess for change in hemoglobin a1c throughout intervention | 13 weeks | 
| Glycemic control | Will assess for change in continuous glucose monitor measures throughout intervention | 13 weeks | 
| BMI | Will assess for change in body mass index (BMI) throughout intervention | 13 weeks |