Taking people in United StatesNo phase

Tests a sleep lengthening program in teens with type 2 diabetes

Studies whether longer sleep, encouraged by a loss-framed incentive, affects blood sugar in teens.

Key facts

Who runs it: Children's Hospital of Philadelphia
Where: Philadelphia, United StatesSee the site
Trial code: NCT04213547
Registry title: Sleep and Glycemic Control in Type 2 Diabetes Adolescents
Status: Recruiting
People taking part: 90 people, planned
Started: 16 Sept 2020
Expected to end: 1 Jul 2028
Type of study: Interventional
Treatments tested: Loss frame sleep extension intervention
Record updated: 29 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for teenagers and young people aged 12-20 with type 2 diabetes. It studies how sleep relates to blood sugar control.

Age: 12 to 20 years
Sex: All sexes can join.
Disease stage: Type 2 diabetes confirmed by standard lab tests, with no pancreatic autoimmunity. Low chance of obstructive sleep apnea on a sleep survey. For the sleep-extension part: average sleep under 8 hours a night, HbA1c of 10% (86 mmol/mol) or less, and adherence above 80% (851 mmol/mol).
Earlier treatment: Taking diabetes treatment (diet changes, Metformin and/or insulin) is allowed. No oral or IV steroids in the past month.
Biomarker or test result: HbA1c must be measurable at the clinic on the day of recruitment. For the sleep-extension part, HbA1c of 10% (86 mmol/mol) or less.

Main reasons for not taking part

Other types of diabetes, such as type 1 diabetes
Known obstructive sleep apnea or another sleep disorder
Known pregnancy
Hyperthyroidism, pain syndrome, or a serious illness that can affect sleep
Does not speak English; for the sleep-extension part, no smartphone or tablet

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

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:
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

Who cannot take part

Oral or IV steroid treatment within the past month
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:
Subjects with hemoglobinopathies that affect hemoglobin A1c measurement
Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment
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)
Do not own a smart phone or tablet; Focus group for child:
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 12 and 20 years old?

Where in United States

Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Talia Hitt, MD/MPHTaking people

About the trial

What the trial wants 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 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.

The group in the trial

InterventionTreatment being tested
This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.
Treatment: Loss frame sleep extension intervention