Type 1 DiabetesSLEEPT1DNCT04975230
Self-Management in Young Adults With Type 1 Diabetes
A study testing Sleep Self-Management in people with Type 1 Diabetes, run by Case Western Reserve University at 1 site in United States.
Trial summary
Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes… Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sleep Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) Age range: from 18 to 26 years
- 2) Diagnosed with T1D for at least 6 months
- 3) No other major health problems (e.g., chronic medical condition or major psychiatric illness
- 4) Not currently participating in any intervention studies
- 5) Read/speak English
- 6) Have a most recent A1C or eA1C value ≥ 7%.
Who cannot join
- 1) Previous OSA diagnosis/high-risk sleep apnea
- 2) Current pregnancy
- 3) Night shift workers
- 4) Habitually sleep > 7 hours on work or school days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106-4904
About this study
Official title: Sleep, Glycemia, and Self-Management in Young Adults With Type 1 Diabetes
Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. Modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with T1D. Therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population.
The overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.
Read the detailed description
This is a two-arm randomized controlled trial, with participants assigned to either the Sleep Self-Management arm or the attention control arm (Diabetes Self-Management Education). The Sleep Self-Management condition involves an initial 50-minute face-to-face consultation with brief 5-10 minute weekly follow-ups in a format TBD by aim 1 (e.g., call, text, video conference) with 3-week booster sessions in person. The Sleep Self-Management intervention activities are provided in addition to "usual care."
- Conditions
- Type 1 Diabetes
- Being tested
- Sleep Self-Management
- Keywords
- Young Adult
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Self-ManagementBehavioural
Intervention delivered by a sleep coach will include 1) initial in-person 50 min consultation; 2) brief 5 min weekly follow ups in a format TBD; and 3) in-person 30 min booster sessions every 3 weeks (total 13 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Sleep Self-Management | Experimental | The Sleep Self-Management Intervention involves an initial 50-minute face-to-face interactive session in a private location. Participants are asked to extend time in bed by 1 hour and consistently maintain the extension on both weekends and weekdays. Bedtimes and waketimes will be assessed to ascertain which time is most modifiable for the participant's lifestyle and routine. There will be weekly follow-ups and in-person 3-week booster sessions. Sleep reports generated by the actigraphy will be shared with participants with brief action planning and goal setting to address progress towards goal achievement. A need to revise plans for future weeks will be the booster sessions' major goal. Receives: Behavioral: Sleep Self-Management |
| Diabetes Self-Management Education | No intervention | The Attention Control arm will receive Diabetes Self-Management Education at the initial consultation visit via in-person contact at T1. There will be weekly follow-ups and in-person 3-week sessions. A Diabetes Self-Management Tracking Form will be used to monitor the weekly acquisition of information and plans for the 6-week intervention and at the 3-month and 6-month data points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)
Average sleep duration as assessed as the average minutes per night participants spent asleep over the 7-14 days preceding each time point (Change in sleep duration (longer sleep duration indicates improvement).
Measured: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Time in Range 70-180 mg/dL
Change in time in range 70-180mg/dL over the monitoring period (7-14 days). Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 [trademark]
Measured: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Secondary outcomes (5)
Diabetes Self-Management Questionnaire (27-item)
Change in Diabetes Self-Management Questionnaire (DSMQ) scores. The DSMQ is a 27-item scale assessing behaviors and activities related to diabetes self-management. Each item is scored on a 4-point Likert scale from 0 (does not apply to me) to 3 (applies to me very much), and items scores are summed/transformed to a total score (range 0 to 10) reflecting overall diabetes self-management, with higher scores indicating better self-management skills (better outcome). This outcome represents the change in scores from baseline to post intervention. Diabetes self-management is an ongoing process where individuals actively manage their condition to maintain optimal blood sugar levels, prevent complications, and improve their overall quality of life.
Measured: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Paper-based Trail Making Test Parts A and B (Executive Function)
Change in executive function (lower scores indicate improvement). The Trail Making Test (TMT) consists of two parts, A and B, which assess performance/cognitive function as the time taken to complete each part in seconds. In Part A, numbered circles (1-25) are connected in ascending order as quickly as possible. In Part B, circles are connected in ascending order with the added task of alternating between numbers and letters (1-A-2-B, etc.). Both parts are summed and scored based on the time taken to complete the task, with higher scores (longer time) indicating greater cognitive impairment.
Measured: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form
Change in general distress (lower scores indicate improvement). The Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form is an 8-item instrument to assess depression symptoms. Each item is scored on a 5-point Likert scale from 1 (Never) to 5 (Always). Total raw scores range from 8-40 with higher scores indicating greater depressive symptoms.
Measured: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Diabetes Distress Scale (17-item)
Change in diabetes distress (lower scores indicate improvement). The Diabetes Distress Scale (DDS) is a 17-item tool to measure emotional distress as experienced by individuals living with diabetes. Each item is scored on a 6-point Likert scale from 1 (Not a Problem) to 6 (A Very Serious Problem) with a total score range of 17-102
Measured: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Diabetes Symptom Checklist Revised (34-item)
Change in diabetes physical symptoms (lower scores indicate improvement). The Diabetes Symptom Checklist Revised (DSC-R) is a 34-item checklist to assess type 2 diabetes symptom burden using a 5-point Likert scale ranging from 0 (Not at all) to 5 (Extremely) with a total score range of 0-170 where higher scores indicate increased symptom burden
Measured: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start29 Apr 2022
- Primary completion31 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral: Sleep self-management
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Stephanie Griggs, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975230
- Sponsor's protocol ID
- STUDY20201829
- Other IDs
- K99NR018886, R00NR018886
- Acronym
- SLEEPT1D
- Status last verified
- Jan 2026
- First submitted
- 9 Jul 2021
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Glycemia, and Self-Management in Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04975230
- Acronym / sponsor ID
- SLEEPT1D / STUDY20201829
- Conditions
- Type 1 Diabetes
- Keywords
- Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. Modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with T1D. Therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population.
The overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.
Detailed description
This is a two-arm randomized controlled trial, with participants assigned to either the Sleep Self-Management arm or the attention control arm (Diabetes Self-Management Education). The Sleep Self-Management condition involves an initial 50-minute face-to-face consultation with brief 5-10 minute weekly follow-ups in a format TBD by aim 1 (e.g., call, text, video conference) with 3-week booster sessions in person. The Sleep Self-Management intervention activities are provided in addition to "usual care."
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Behavioral: Sleep self-management
| Arm | Type | Receives |
|---|---|---|
| Sleep Self-Management | Experimental | Behavioral: Sleep Self-ManagementThe Sleep Self-Management Intervention involves an initial 50-minute face-to-face interactive session in a private location. Participants are asked to extend time in bed by 1 hour and consistently maintain the extension on both weekends and weekdays. Bedtimes and waketimes will be assessed to ascertain which time is most modifiable for the participant's lifestyle and routine. There will be weekly follow-ups and in-person 3-week booster sessions. Sleep reports generated by the actigraphy will be shared with participants with brief action planning and goal setting to address progress towards goal achievement. A need to revise plans for future weeks will be the booster sessions' major goal. |
| Diabetes Self-Management Education | No intervention | –The Attention Control arm will receive Diabetes Self-Management Education at the initial consultation visit via in-person contact at T1. There will be weekly follow-ups and in-person 3-week sessions. A Diabetes Self-Management Tracking Form will be used to monitor the weekly acquisition of information and plans for the 6-week intervention and at the 3-month and 6-month data points. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1) Age range: from 18 to 26 years
- 2) Diagnosed with T1D for at least 6 months
- 3) No other major health problems (e.g., chronic medical condition or major psychiatric illness
- 4) Not currently participating in any intervention studies
- 5) Read/speak English
Key exclusion criteria (4 listed)
- 1) Previous OSA diagnosis/high-risk sleep apnea
- 2) Current pregnancy
- 3) Night shift workers
- 4) Habitually sleep > 7 hours on work or school days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Self-ManagementIntervention delivered by a sleep coach will include 1) initial in-person 50 min consultation; 2) brief 5 min weekly follow ups in a format TBD; and 3) in-person 30 min booster sessions every 3 weeks (total 13 sessions). | Behavioural | Sleep Self-Management |
Primary outcome
Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)
Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Average sleep duration as assessed as the average minutes per night participants spent asleep over the 7-14 days preceding each time point (Change in sleep duration (longer sleep duration indicates improvement).
Time in Range 70-180 mg/dL
Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Change in time in range 70-180mg/dL over the monitoring period (7-14 days). Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 [trademark]
5 secondary outcomes
Diabetes Self-Management Questionnaire (27-item)
Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Paper-based Trail Making Test Parts A and B (Executive Function)
Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form
Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Diabetes Distress Scale (17-item)
Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Diabetes Symptom Checklist Revised (34-item)
Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Griggs, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Self-Management in people with Type 1 Diabetes, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus) (time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.