Clinical trial NCT04213547: 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
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-12-30
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.

A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep duration (for Aim 2)
timeFrame: 13 weeks
measure: Hemoglobin A1c (for Aim 1)
timeFrame: baseline
measure: BMI (for Aim 1)
timeFrame: baseline
measure: Qualitative data from focus group
timeFrame: baseline at focus group
Secondary outcomes:
measure: Glycemic control
timeFrame: 13 weeks
measure: Glycemic control
timeFrame: 13 weeks
measure: BMI
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Talia A Hitt, MD/MPH
role: STUDY_DIRECTOR
References:
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