Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALLoss 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.
Sponsors
Children's Hospital of Philadelphia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep duration (for Aim 2) | 13 weeks | Will assess for sleep extension throughout intervention |
| Hemoglobin A1c (for Aim 1) | baseline | Aim 1 is assessing cross-sectional relationship of A1c to sleep duration |
| BMI (for Aim 1) | baseline | Aim 1 is assessing cross-sectional relationship of BMI to sleep duration |
| Qualitative data from focus group | baseline at focus group | Qualitative output from focus group discussion on text messages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 13 weeks | Will assess for change in hemoglobin a1c throughout intervention |
| BMI | 13 weeks | Will assess for change in body mass index (BMI) throughout intervention |
Countries
United States
Contacts
CONTACTTalia Hitt, MD/MPH
CONTACTBeth Schwartzman
STUDY_DIRECTORTalia A Hitt, MD/MPH
Children's Hospital of Philadelphia
Outcome results
None listed