NCT04213547Recruiting
Sleep and Glycemic Control in Type 2 Diabetes Adolescents
Sleep Duration and Glycemic Control in Adolescents With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 26 Dec 2019
- Start date
- Sept 2020
- Primary completion date
- Jul 2028
- Lead sponsor
- Children's Hospital of Philadelphia
- Diseases
- Type 2 diabetes
- NCT number
- NCT04213547
What you commit to
- Study type: Interventional
- Planned participants: 90
- From Sept 2020 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Oral or IV steroid treatment within the past month
Other illness
- Patients with other forms of Diabetes Mellitus (e.g. Type 1 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.
- Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep.
- Known diagnosis of obstructive sleep apnea or other sleep disorder
- Aim 1 for Parent:
- 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:
Lab values
- Subjects with hemoglobinopathies that affect hemoglobin A1c measurement.
- Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment
Other
- Aim 1 for child:
- 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.
- 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.
- Non-English speaking subject (as questionnaires used are validated in English)
- Non-English speaking subject (as focus group will be conducted in English)
- Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing
Who the study is looking for
- Aim 1 for child:
- 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)
- 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:
- Completed Aim 1 evaluation
- Average sleep duration \< 8 hours per night as determined by actigraphy in Aim 1
- HbA1c ≤ 10% as HbA1c \>10 correlates to poor adherence
- Adherence \> 80%
- Focus group for child:
- Subjects aged 12-20
- Diagnosed with type 2 diabetes without pancreatic autoimmunity
Age in the registry: 12 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.