Sleep Extension Intervention for Type 2 Diabetes Adolescents
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Sleep Extension Intervention for Type 2 Diabetes Adolescents?
Research on sleep extension in adolescents with type 1 diabetes suggests that improving sleep can lead to better blood sugar control. This implies that similar sleep-focused treatments might also help adolescents with type 2 diabetes manage their condition more effectively.
12345Is sleep extension intervention safe for adolescents with type 2 diabetes?
The available research does not specifically address the safety of sleep extension interventions for adolescents with type 2 diabetes, but sleep interventions have been studied in other contexts, such as type 1 diabetes, without reported safety concerns.
26789How does the sleep extension treatment for type 2 diabetes in adolescents differ from other treatments?
The sleep extension treatment is unique because it focuses on increasing sleep duration to improve blood sugar control in adolescents with type 2 diabetes, rather than using medication or dietary changes. This approach is novel as it targets sleep as a modifiable factor to enhance metabolic health, which is not a standard treatment for this condition.
2391011Eligibility Criteria
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.
+4 more
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.
+8 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of PhiladelphiaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Children's Hospital of PhiladelphiaLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Sleep in Adolescents and Young Adults with Type 1 Diabetes: Associations with Diabetes Management and Glycemic Control. [2020]To describe sleep in adolescents and young adults with type 1 diabetes and explore the association between sleep disturbances, diabetes management and glycemic control.
Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. [2023]Sleep deficiencies amongst individuals with type 1 diabetes mellitus (T1DM) have been linked with dysregulated glycemic control and greater morbidities. Sleep extension (EXT) has been identified as a viable intervention target to improve adolescent outcomes. The intervention aims to emphasize collaborative work with families to engage in behaviors that increase the likelihood of the youth increasing their sleep duration consistently. This study will randomize up to 175 youth with T1DM and at least one caregiver to either an EXT intervention or a family routines support (FRS) consultation. It is hypothesized that the EXT condition will lead to improvements in sleep, which in turn, will contribute to improved glycemic control. The primary endpoint is improved glycemic control assessed via a continuous glucose monitor (CGM) to ascertain average glucose levels across a week, glycemic variability, and percent time in the target range at one month and HbA1c at three months. Analyses will control for co-morbid conditions, including sleep-disordered breathing and obesity. This study will provide the needed data to support addressing sleep as part of the standards of care in youth with T1DM.
Sleep coach intervention for teens with type 1 diabetes: Randomized pilot study. [2022]Teens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep represents a novel target to improve outcomes in teens.
Evaluation of sleep characteristics of children and adolescents with type 1 diabetes mellitus. [2021]To evaluate sleep characteristics of children and adolescents with type 1 diabetes mellitus (T1DM) and their relationship with glycemic control.
Objective and Subjective Sleep Patterns in Adults With Maturity-Onset Diabetes of the Young (MODY). [2023]To examine sleep patterns in adults with maturity-onset diabetes of the young (MODY).
Sleep architecture and glucose and insulin homeostasis in obese adolescents. [2022]Sleep deprivation is associated with increased risk of adult type 2 diabetes mellitus (T2DM). It is uncertain whether sleep deprivation and/or altered sleep architecture affects glycemic regulation or insulin sensitivity or secretion. We hypothesized that in obese adolescents, sleep disturbances would associate with altered glucose and insulin homeostasis.
Metabolic and glycemic sequelae of sleep disturbances in children and adults. [2022]The prevalence of obesity in adults and children has increased greatly in the past three decades, as have metabolic sequelae, such as insulin resistance and type 2 diabetes mellitus (T2DM). Sleep disturbances are increasingly recognized as contributors to this widespread epidemic in adults, and data are emerging in children as well. The categories of sleep disturbances that contribute to obesity and its glycemic co-morbidities include the following: (1) alterations of sleep duration, chronic sleep restriction and excessive sleep; (2) alterations in sleep architecture; (3) sleep fragmentation; (4) circadian rhythm disorders and disruption (i.e., shift work); and (5) obstructive sleep apnea. This article reviews current evidence supporting the contributions that these sleep disorders play in the development of obesity, insulin resistance, and T2DM as well as possibly influences on glycemic control in type 1 diabetes, with a special focus on data in pediatric populations.
Impact of the Hybrid Closed-Loop System on Sleep and Quality of Life in Youth with Type 1 Diabetes and Their Parents. [2021]Background: Insufficient sleep is common in youth with type 1 diabetes (T1D) and parents, likely secondary to diabetes-related disturbances, including fear of hypoglycemia, nocturnal glucose monitoring, hypoglycemia, and device alarms. Hybrid closed-loop (HCL) systems improve glycemic variability and potentially reduce nocturnal awakenings. Methods: Adolescents with T1D (N = 37, mean age 13.9 years, 62% female, mean HbA1c 8.3%) and their parents were enrolled in this observational study when starting the Medtronic 670G HCL system. Participants completed study measures (sleep and psychosocial surveys and actigraphy with sleep diaries) before starting auto mode and ∼3 months later. Results: Based on actigraphy data, neither adolescents' nor parents' sleep characteristics changed significantly pre-post device initiation. Adolescents' mean total sleep time decreased from 7 h 16 min (IQR: [6:43-7:47]) to 7 h 9 min (IQR: [6:44-7:52]), while parents' total sleep time decreased from 6 h 47 min (IQR: [6:16-7:10]) to 6 h 38 min (IQR: [5:57-6:57]). Although there were no significant differences in most of the survey measures, there was a moderate effect for improved sleep quality in parents and fear of hypoglycemia in adolescents. In addition, adolescents reported a significant increase in self-reported glucose monitoring satisfaction. Adolescents averaged 44.7% use of auto mode at 3 months. Conclusions: Our data support previous research showing youth with T1D and their parents are not achieving the recommended duration of sleep. Lack of improvement in sleep may be due to steep learning curves involved with new technology. We observed moderate improvements in parental subjective report of sleep quality despite no change in objective measures of sleep duration. Further evaluation of sleep with long-term HCL use and larger sample size is needed.
Associations of sleep duration and quality with disinhibited eating behaviors in adolescent girls at-risk for type 2 diabetes. [2019]Short sleep duration and daytime sleepiness have been associated with an increased risk for the onset of type 2 diabetes in adults. There has been far less attention to the characterization of sleep in adolescents at-risk for diabetes or to the possible behavioral mechanisms, such as disinhibited eating, through which sleep may affect metabolic functioning.
Inadequate sleep as a contributor to type 2 diabetes in children and adolescents. [2022]Lack of sleep is a modifiable risk factor for adverse health in humans. Short sleep duration and poor sleep quality are common in the pediatric population; the largest decline in sleep duration over the past decades has been seen in children and adolescents. The objective of the present narrative review was to provide for the first time an overview of the literature on sleep and its association with type 2 diabetes mellitus (T2D) biomarkers in children and adolescents. For this narrative review, 23 studies were retained (21 observational and 2 experimental studies). Notwithstanding the conflicting results found in these studies and despite being attenuated by adiposity level, maturity, sex and age, there is still some compelling evidence for an association between sleep duration (for both objective or subjective measurements of duration) and architecture with one or more T2D biomarkers in children and adolescents. The majority of the studies reviewed did focus on sleep duration and one or more T2D biomarkers in children and adolescents, but sleep architecture, more precisely the suppression of slow wave sleep and rapid eye movement sleep, has also been shown to be associated with insulin resistance. Only two studies looked at sleep quality, and the association between sleep quality and insulin resistance was not independent of level of adiposity. Future experimental studies will help to better understand the mechanisms linking insufficient sleep with T2D. Work also needs to be carried out on finding novel and effective strategies aimed at improving sleep hygiene and health outcomes of children and adolescents.
Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial. [2022]While limited evidence suggests that longer sleep durations can improve metabolic health in habitual short sleepers, there is no consensus on how sustained sleep extension can be achieved. A total of 18 men (mean [SD] age 41 [ 9] years), who were overweight/obese (mean [SD] body mass index 30 [3] kg/m2 ) and short sleepers at increased risk of type 2 diabetes were randomised to a 6-week sleep-extension programme based on cognitive behavioural principles (n = 10) or a control (n = 8) group. The primary outcome was 6-week change in actigraphic total sleep time (TST). Fasting plasma insulin, insulin resistance (Homeostatic Model Assessment for Insulin Resistance [HOMA-IR]), blood pressure, appetite-related hormones from a mixed-meal tolerance test, and continuous glucose levels were also measured. Baseline to 6-week change in TST was greater in the sleep-extension group, at 79 (95% confidence interval [CI] 68.90, 88.05) versus 6 (95% CI -4.43, 16.99) min. Change in the sleep-extension and control groups respectively also showed: lower fasting insulin (-11.03 [95% CI -22.70, 0.65] versus 7.07 [95% CI -4.60, 18.74] pmol/L); lower systolic (-11.09 [95% CI -17.49, -4.69] versus 0.76 [95% CI -5.64, 7.15] mmHg) and diastolic blood pressure (-12.16 [95% CI -17.74, -6.59] versus 1.38 [95% CI -4.19, 6.96] mmHg); lower mean amplitude of glucose excursions (0.34 [95% CI -0.57, -0.12] versus 0.05 [95% CI -0.20, 0.30] mmol/L); lower fasting peptide YY levels (-18.25 [95%CI -41.90, 5.41] versus 21.88 [95% CI -1.78, 45.53] pg/ml), and improved HOMA-IR (-0.51 [95% CI -0.98, -0.03] versus 0.28 [95% CI -0.20, 0.76]). Our protocol increased TST and improved markers of metabolic health in male overweight/obese short sleepers.