No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 20
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
90 (estimated)
Sponsor
Children's Hospital of Philadelphia · Other
Who this trial is looking for
This trial is looking for teenagers aged 12-20 who have type 2 diabetes and want to improve their sleep. Participants will take part in activities related to their sleep patterns and how it affects their blood sugar control.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 12 and 20 years old.
I have been diagnosed with type 2 diabetes.
I have parental or guardian permission.
I have average sleep duration of less than 8 hours per night.
My blood sugar levels (HbA1c) are 10% or lower.
You may not be able to join if
I do not speak English.
I have type 1 diabetes.
I have a serious medical condition that affects my sleep.
I am currently pregnant.
I have been on steroid treatment in the past month.
I have obstructive sleep apnea or another sleep disorder.
I have a behavioral disorder that affects how I answer questions.
I cannot participate in activities using my phone or tablet.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 insuffici…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.