Investigating the link between sleep and blood sugar control in adolescents with Type 2 Diabetes

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

This study is testing if getting more sleep can help teenagers with Type 2 Diabetes better control their blood sugar levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 12 Years to 20 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT04213547 on ClinicalTrials.gov

What this trial studies

This study aims to explore the relationship between sleep duration and glycemic control in adolescents aged 12-20 diagnosed with Type 2 Diabetes. Participants will wear actigraphy devices for 14 days to monitor their sleep patterns and use continuous glucose monitors to assess their blood sugar levels. Additionally, a loss-framed incentive intervention will be implemented to encourage increased sleep duration in a subset of participants with insufficient sleep. The study will also involve focus groups to gather insights on effective communication strategies for participants.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-20 diagnosed with Type 2 Diabetes who are currently undergoing treatment.

Not a fit: Patients who are non-English speaking or have severe obstructive sleep apnea may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved sleep habits and better glycemic control in adolescents with Type 2 Diabetes.

How similar studies have performed: Other studies have shown promising results in improving glycemic control through lifestyle interventions, making this approach both relevant and potentially impactful.

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

Where this trial is running

Philadelphia, Pennsylvania

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Talia Hitt, MD/MPH

Conditions Type 2 Diabetes