Sleep Health Self-Management for Type 1 Diabetes

Overseen By Estefania Hernandez, MPH, MA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Heart failure, Severe psychiatric illness, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

248 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C \<7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population. Our primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that if you have treated sleep apnea, you must continue your treatment during the study.

Is the Sleep Health Self-Management treatment safe for humans?

Research on sleep interventions for diabetes is still in early stages, but cognitive-behavioral therapy for insomnia (CBT-I), a similar approach, has been explored and is generally considered safe for improving sleep in people with diabetes. ^{1 2 3 4 5}

How is the CB Sleep treatment different from other treatments for type 1 diabetes?

The CB Sleep treatment is unique because it focuses on improving sleep through cognitive-behavioral techniques, which can help manage type 1 diabetes by addressing sleep disturbances that affect blood sugar control. Unlike traditional diabetes treatments that focus directly on insulin and blood sugar levels, this approach targets sleep as a modifiable factor to enhance overall diabetes management. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment CB Sleep for managing sleep health in people with Type 1 Diabetes?

Research suggests that improving sleep can help manage blood sugar levels in people with Type 1 Diabetes. Sleep disturbances are common in this group and can negatively impact diabetes management. Cognitive-behavioral sleep interventions, like CB Sleep, may support better sleep and potentially improve diabetes outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Stephanie Griggs, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-31 with Type 1 Diabetes who are not meeting their glycemic targets and have at least one issue with sleep health. They must have been diagnosed for over a year, speak English, and be willing to continue any current sleep apnea treatment. People with severe chronic conditions, psychiatric illnesses, untreated sleep apnea, or those unable to follow the study protocol cannot participate.

Inclusion Criteria

I have been diagnosed with Type 1 Diabetes for over a year and meet the additional criteria.

I have issues with my sleep, such as feeling unsatisfied, alertness problems, irregular sleep times, low efficiency, or sleeping less than 7 hours.

My blood sugar control is not on target.

Exclusion Criteria

Current pregnancy

Unable to complete protocol (e.g., bereavement, currently homeless)

You have recently worked night shifts or traveled across different time zones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline measures including questionnaires and 14-days of sleep/glucose monitoring

2 weeks

1 visit (in-person or virtual)

Treatment

Participants receive a 12-week CB-sleep intervention or enhanced usual care

12 weeks

Weekly follow-ups (email, phone, text, video chat) and telehealth 4-week booster sessions

Follow-up

Participants are monitored for sleep health and diabetes self-management outcomes

6 months

Follow-up assessments at 3, 6, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• CB Sleep

Trial Overview The trial tests a CB-sleep intervention against enhanced usual care in improving sleep health dimensions and diabetes self-management outcomes over nine months. The CB-sleep program includes motivational interviewing techniques tailored to participants' readiness to change their behavior.

How Is the Trial Designed?

Group I: CB-sleep Experimental Treatment 1 Intervention

Initial instruction for the CB-sleep intervention will occur 60-minute telehealth session. The initial action planning session with a sleep report and booster sessions will be interactive and stage matched. The intervention will include an interactive PowerPoint with the participant's clinician sleep report with personalized feedback. They will be encouraged to systematically extend their time in bed by 1 hour and maintain the extension on both weekends and weekdays. Weekly titration will occur according to the following parameters: if sleep efficiency is ≥ 85%, time in bed is increased by 15 minutes per week until a total of a 1 hour increase in time in bed is achieved, if sleep efficiency is \<85%, time in bed remains the same. There will be weekly follow-ups (email, phone, text, video chat) and telehealth 4-week booster sessions. Sleep reports generated by the baseline actigraphy report will be shared with participants with brief action planning and goal setting.

Group II: Attention Control Enhanced Usual Care arm Active Control 1 Intervention

After baseline, the RA assigned to this condition will schedule a 60-minute telehealth appointment to provide instruction for enhanced usual care at the initial consultation visit via contact at T1 (60-minute telehealth session in a private location). The time-balanced follow-up sessions will remain neutral and focused on health perceptions, current plan of care, and relationship building as opposed to the CB-sleep condition's focus on sleep promotion and extension. The RA assigned to the control condition will ask participants to (a) describe how they are doing and (b) ask how confident they are in achieving the goals they have set for themselves. These calls will help to build a relationship with participants to promote study retention. The investigators recognize that participants may obtain self-initiated diabetes self-management in this group, which will vary and will use a Diabetes Self-Management Tracking Form to monitor weekly information acquisition.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Numerous studies over the past 25 years indicate that poor sleep quality is linked to impaired glucose tolerance and decreased insulin sensitivity, which can lead to type 2 diabetes, affecting over half of people with type 2 diabetes and one-third of those with type 1 diabetes.

There is a need for more research on interventions to improve sleep in individuals with diabetes, as better sleep may enhance glycaemic control and overall self-care, highlighting the importance of addressing sleep in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sweet dreams or bitter nightmare: a narrative review of 25 years of research on the role of sleep in diabetes and the contributions of behavioural science. Nefs, GM., Bazelmans, E., Donga, E., et al.[2021]

This study will evaluate the effectiveness of a sleep optimization intervention (Sleep-Opt) in improving sleep quality and glycemic control in 120 adults with type 1 diabetes over 12 weeks, focusing on sleep variability, duration, and A1C levels.

The Sleep-Opt intervention combines technology-assisted behavioral strategies, including a wearable sleep tracker and a smartphone app, aiming to enhance self-management behaviors and overall quality of life for individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Martyn-Nemeth, P., Duffecy, J., Quinn, L., et al.[2023]

Individuals with type 1 diabetes often experience sleep disruptions due to both behavioral factors and the physiological effects of the disease and its management.

These sleep disturbances can have negative impacts on the progression of diabetes and the development of related complications, emphasizing the importance of addressing sleep quality in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 Diabetes and Sleep. Farabi, SS.[2020]

Individuals with type 1 diabetes (T1D) experience more sleep disturbances than those without diabetes, which negatively affects their blood sugar control and overall diabetes management.

Inconsistent sleep timing is linked to poorer glycemic control, suggesting that interventions aimed at improving sleep consistency could enhance diabetes management and psychosocial outcomes for people with T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. Perez, KM., Hamburger, ER., Lyttle, M., et al.[2020]

A study involving 16 young adults with type 1 diabetes revealed that a cognitive behavioral sleep self-management intervention (CB-sleep) is perceived as beneficial for improving sleep knowledge and health goals.

Participants identified various barriers and facilitators to the CB-sleep intervention, suggesting it could be effectively integrated into diabetes self-management programs to enhance both sleep quality and glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Sleep Self-Management Intervention for Young Adults With Type 1 Diabetes (NCT04975230). Griggs, S., Hernandez, E., Bolton, PJ., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved glycemic control, diabetes self-care behavior, and fatigue in individuals with type 2 diabetes and insomnia symptoms, based on a study of 28 participants over 6 weeks.

No adverse events were reported during the study, indicating that CBT-I is a safe intervention, and there was a notable association between the duration of CBT-I participation and lower blood glucose levels at bedtime and upon waking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes. Alshehri, MM., Alothman, SA., Alenazi, AM., et al.[2022]

An ongoing study is examining the relationship between sleep deficiency and glycemic control in 40 emerging adults with Type 1 Diabetes (T1D), using methods like wrist-worn actigraphy and continuous glucose monitoring over 14 days.

The study aims to develop a tailored sleep self-management intervention that could potentially improve sleep quality, neurocognitive function, and diabetes management, addressing the low glycemic control rates in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, self-management, neurocognitive function, and glycemia in emerging adults with Type 1 diabetes mellitus: A research protocol. Griggs, S., Redeker, NS., Crawford, SL., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Sweet dreams or bitter nightmare: a narrative review of 25 years of research on the role of sleep in diabetes and the contributions of behavioural science. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Type 1 Diabetes and Sleep. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Sleep Self-Management Intervention for Young Adults With Type 1 Diabetes (NCT04975230). [2023]

6. England pubmed.ncbi.nlm.nih.gov

The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sleep, self-management, neurocognitive function, and glycemia in emerging adults with Type 1 diabetes mellitus: A research protocol. [2021]