Sleep Extension Intervention for Type 2 Diabetes Adolescents

Overseen By Beth Schwartzman

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must be taking: Metformin, Insulin

Must not be taking: Steroids

Disqualifiers: Type 1 diabetes, Autism, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep affects blood sugar control in teens with Type 2 Diabetes, a condition where the body struggles to manage blood sugar. Researchers aim to determine if improving sleep through specific incentives, known as the loss frame sleep extension intervention (a behavioral sleep intervention), can enhance diabetes management. Teens with Type 2 Diabetes who typically sleep less than 8 hours a night might be suitable candidates. Participants will wear a device to track sleep and may receive incentives to help achieve sleep goals. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve diabetes management for teens.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on treatments like diet modification, Metformin, and/or insulin.

What prior data suggests that this sleep extension intervention is safe for adolescents with Type 2 Diabetes?

Research has shown that increasing sleep has been tested in teenagers at risk for type 2 diabetes. These studies examined whether more sleep could improve insulin use in the body. Although the studies did not focus on safety, they reported no serious side effects or harm.

In the SMART2D study, more sleep slightly increased daytime physical activity, suggesting it could be a healthy change. However, specific safety information for teenagers with type 2 diabetes is lacking.

Overall, more sleep appears safe. Studies on similar sleep interventions have reported no safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this sleep extension intervention for adolescents with Type 2 diabetes because it takes a unique behavioral approach. Unlike standard treatments that focus on medication and dietary changes, this intervention uses a loss-framed incentive strategy to encourage longer sleep duration. This approach could improve blood sugar control by addressing sleep, a factor often overlooked in diabetes management. By potentially enhancing adherence through incentives, this method offers a novel way to tackle diabetes management from a behavioral perspective.

What evidence suggests that this sleep extension intervention is effective for improving glycemic control in adolescents with Type 2 Diabetes?

Research has shown that more sleep might help teenagers with Type 2 Diabetes manage their blood sugar better. Studies have found that increased sleep can make the body use insulin more effectively, aiding in blood sugar control. This trial will use a loss-framed incentive intervention to encourage longer sleep duration. One study discovered that offering rewards for longer sleep successfully increased sleep duration in teenagers. By focusing on more sleep, teenagers might improve their overall diabetes management. ^{1 2 6 7 8}

Who Is on the Research Team?

Talia A Hitt, MD/MPH

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Adolescents aged 12-20 with Type 2 Diabetes, HbA1c ≤ 10%, sleeping less than 8 hours per night, and a low risk of sleep apnea can join. They must be on T2DM treatments like diet changes or medications, have good treatment adherence, and own a smartphone. Those with recent steroid use, other serious health issues affecting sleep, non-English speakers, certain hemoglobinopathies or behavioral disorders are excluded.

Inclusion Criteria

I am currently managing my type 2 diabetes with diet, Metformin, or insulin.

You sleep less than 8 hours per night on average, as measured by a special device called actigraphy.

I follow my treatment plan at least 80% of the time.

Exclusion Criteria

I am not pregnant, as pregnancy can affect sleep patterns.

I am not living in an institution which affects my sleep patterns.

I have a blood condition that affects my hemoglobin A1c levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete intake questionnaires and are provided with actigraphy watch devices and continuous glucose monitors for baseline data collection

2 weeks

1 visit (in-person)

Intervention

Participants undergo a loss-framed incentive intervention to increase sleep duration, with glycemic control measured pre- and post-intervention

13 weeks

Follow-up

Participants are monitored for changes in sleep duration and glycemic control after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Loss frame sleep extension intervention

Trial Overview The trial is testing if an incentive-based program encouraging more sleep can improve blood sugar control in teens with Type 2 Diabetes who don't get enough sleep. It involves tracking their sleep for two weeks and then seeing if rewards linked to achieving better sleep help them rest more and manage their diabetes better.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Adolescents with type 1 diabetes average only 7.4 hours of sleep, which is below the recommended amount for their age, indicating a need for better sleep hygiene.

Those using insulin pumps experienced fewer sleep disturbances and longer sleep duration compared to those using injections, suggesting that the method of insulin delivery may impact sleep quality and, consequently, diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Adolescents and Young Adults with Type 1 Diabetes: Associations with Diabetes Management and Glycemic Control. Jaser, SS., Ellis, D.[2020]

The study will involve up to 175 adolescents with type 1 diabetes and their caregivers, comparing the effects of a sleep extension intervention against family routines support to improve sleep duration and glycemic control.

It is hypothesized that increasing sleep duration will lead to better glycemic control, measured through continuous glucose monitoring and HbA1c levels, highlighting the importance of sleep in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. Perfect, MM., Silva, GE., Chin, CN., et al.[2023]

The Sleep Coach intervention for teens with type 1 diabetes (T1D) was found to be feasible and acceptable, with 80% of participants completing all sessions and a high retention rate of 90%.

Teens in the Sleep Coach group experienced significant improvements in sleep efficiency and duration, with an average increase of 48 minutes of sleep, while the control group reported poorer sleep quality, although there was no change in their HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep coach intervention for teens with type 1 diabetes: Randomized pilot study. Jaser, SS., Hamburger, ER., Bergner, EM., et al.[2022]

In a study of 119 adolescent girls at risk for type 2 diabetes, shorter sleep duration was linked to increased total energy intake during test meals, suggesting that sleep may influence eating behaviors.

Daytime sleepiness was associated with a higher likelihood of binge eating, indicating that poor sleep may contribute to disinhibited eating patterns that can lead to weight gain and metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of sleep duration and quality with disinhibited eating behaviors in adolescent girls at-risk for type 2 diabetes. Kelly, NR., Shomaker, LB., Radin, RM., et al.[2019]

A 6-week sleep-extension program based on cognitive behavioral principles significantly increased total sleep time by an average of 79 minutes in overweight/obese men who were short sleepers, compared to just 6 minutes in the control group.

Participants in the sleep-extension group also showed improvements in metabolic health markers, including lower fasting insulin levels, reduced blood pressure, and improved insulin resistance, indicating that longer sleep durations can positively impact metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial. Hartescu, I., Stensel, DJ., Thackray, AE., et al.[2022]

Sleep disturbances, including changes in sleep duration, architecture, fragmentation, circadian rhythm disorders, and obstructive sleep apnea, are significant contributors to the rising rates of obesity and related metabolic issues like insulin resistance and type 2 diabetes mellitus (T2DM) in both adults and children.

The review highlights the importance of addressing sleep disorders as a potential intervention to combat obesity and improve glycemic control, particularly in pediatric populations, where data is increasingly emerging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic and glycemic sequelae of sleep disturbances in children and adults. Koren, D., O'Sullivan, KL., Mokhlesi, B.[2022]

In a study of 62 obese adolescents, both insufficient and excessive sleep were linked to higher blood sugar levels and increased risk of type 2 diabetes, indicating that sleep duration is crucial for glycemic control.

Reduced slow-wave sleep (N3) was associated with lower insulin secretion, suggesting that improving sleep quality could help enhance insulin function and potentially prevent type 2 diabetes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep architecture and glucose and insulin homeostasis in obese adolescents. Koren, D., Levitt Katz, LE., Brar, PC., et al.[2022]

There is evidence suggesting that both sleep duration and sleep architecture are associated with type 2 diabetes (T2D) biomarkers in children and adolescents, based on a review of 23 studies, including 21 observational and 2 experimental studies.

The review highlights that while sleep duration is commonly linked to T2D biomarkers, the quality of sleep and its specific phases, like slow wave and REM sleep, also play a role in insulin resistance, indicating a complex relationship that requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadequate sleep as a contributor to type 2 diabetes in children and adolescents. Dutil, C., Chaput, JP.[2022]

In a study of 24 adults with maturity-onset diabetes of the young (MODY), significant sleep disturbances were found, with 88% reporting poor sleep quality and 54% sleeping less than the recommended 7 hours per night.

Participants with transcription factor-related MODY experienced worse sleep quality and more variability in sleep patterns compared to those with glucokinase (GCK)-MODY, highlighting the need for further research on the relationship between sleep and diabetes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective and Subjective Sleep Patterns in Adults With Maturity-Onset Diabetes of the Young (MODY). Arosemena, M., Salguero, MV., Naylor, RN., et al.[2023]

In a study of 37 adolescents with type 1 diabetes and their parents, the introduction of the Medtronic 670G hybrid closed-loop system did not significantly improve sleep duration for either group over a 3-month period, indicating ongoing sleep challenges related to diabetes management.

Despite no objective changes in sleep duration, parents reported moderate improvements in sleep quality and adolescents experienced increased satisfaction with glucose monitoring, suggesting potential psychosocial benefits from using the hybrid closed-loop system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Hybrid Closed-Loop System on Sleep and Quality of Life in Youth with Type 1 Diabetes and Their Parents. Cobry, EC., Hamburger, E., Jaser, SS.[2021]

In a study of 86 children and adolescents with type 1 diabetes, those with higher glycated hemoglobin (HbA1c) levels (≥7.5%) experienced more daytime sleepiness and shorter sleep duration during the week.

The research found that a shorter duration since diagnosis of type 1 diabetes also increased the likelihood of daytime sleepiness, indicating that both poor glycemic control and recent diagnosis may negatively impact sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sleep characteristics of children and adolescents with type 1 diabetes mellitus. Silva, RAE., Ganen, AP., Fernandes, VFT., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-8-2020-eb177

Sleep Extension Intervention for Type 2 Diabetes ... ... Loss frame sleep extension intervention will have tolerable side effects & efficacy for patients with Type 2 Diabetes and Type 2 Diabetes. See if you qualify

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/372616

Sleep and Glycemic Control in Type 2 Diabetes Adolescents A secondary objective is to determine if a loss-framed incentive for achieving sleep goals can increase sleep duration in 15 adolescent patients ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04467268

NCT04467268 | Sleep Extension for Metabolic Health The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1871402125001225

A Randomized Pilot Sleep and Circadian Behavior Clinical ... The cognitive behavioral sleep and circadian intervention improved glycemic outcomes and reduced diabetes distress. In contrast, the control ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03754036

Sleep Extension and Insulin Sensitivity in Adolescents BACKGROUND: The influence of sleep extension on glucose homeostasis in adolescents at risk for type 2 diabetes is unknown. This issue is of high clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11082473/

Sleep and insulin sensitivity in adolescents at risk of type 2 ... We hypothesized that in our population of adolescents at risk for type 2 diabetes, increasing sleep duration for 1 week would result in significant ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03500458

NCT03500458 | Impact of Sleep Extension in Adolescents Type 2 diabetes or prediabetes. IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes) ...

8. academic.oup.com academic.oup.com/sleep/article/47/5/zsae016/7577643

Waking up to sleep extension for cardiometabolic health In the SMART2D study, physical activity during wakefulness was marginally increased (6.8%) with sleep extension compared to habitual sleep but ...