Type 1 DiabetesSOPTNCT04506151

Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes

A study testing Sleep-Opt and Healthy Living in people with Type 1 Diabetes, run by University of Illinois at Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Sleep-Opt and Healthy Living
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteUnited States
Study dates: 19 Jan 2021to 21 Dec 2025
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adults aged 18-65 years
clinical diagnosis of type 1 diabetes minimum of one year
reported habitual sleep variability (1 hour/week or more) or sleep duration less than 6.5 hrs/night during work- or weekdays (confirmed with actigraphy sleep watch)
a desire to improve sleep
own a smartphone

Who cannot join

insomnia symptoms
at high risk for obstructive sleep apnea
severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness)
A1C greater than 10%
rotating shift or night shift work
use of sleep medications/aids

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renal impairment (estimated glomerular filtration rate < 45 ml/min)
significant current medical morbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, depression, history of stroke with neurological deficits
breast feeding, pregnant, or planning pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Illinois Chicago
Chicago, Illinois, 60612

Other trials in United States

About this study

Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with negative health consequences including poor blood glucose control and greater diabetes complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep tracking technology, telephone coaching and informational content designed to improve sleep and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to reduced development of diabetes complications and improve quality of life for adults with type 1 diabetes.

Read the detailed description

Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life (QoL) have also been linked to sleep variability and insufficient sleep duration. The American Diabetes Association Standards of Medical Care in Diabetes incorporated sleep as an important component of the medical evaluation in persons with diabetes. However, no specific recommendation was given as to how to improve sleep. A significant gap of knowledge exists regarding the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration and glycemic control (A1C); other glycemic parameters (glycemic variability, time in range), diabetes distress, self-management behavior, QoL, and other patient reported outcomes in working-age adults with T1D and habitual increased sleep variability or short sleep duration. To achieve these aims, a randomized controlled trial is planned in 120 working age adults (18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 hour/week) or insufficient sleep duration (< 6.5 hours per night). Eligible subjects will be randomized to the Sleep-Opt group or healthy living attention control group for twelve weeks. A one-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and time in range using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that this study team developed that leverages the rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). The behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. At midpoint (Week 6) completion (Week 12) and post-program (Week 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention.

Conditions: Type 1 Diabetes
Being tested: Sleep-Opt, Healthy Living
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-OptBehavioural
12-week behavioral intervention
Healthy LivingBehavioural
Healthy Living

Study groups in NCT04506151
Study group	Role	What they receive
Sleep-Opt	Experimental	12-week intervention that includes self-monitoring, goal setting, motivational enhancement. Receives: Behavioral: Sleep-Opt
Healthy Living	Active comparator	12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group. Receives: Behavioral: Healthy Living

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Variability Week 6
Standard deviation total sleep time for one week
Measured: Week 6
Sleep Variability Week 12
Standard deviation total sleep time for one week
Measured: Week 12
Sleep Variability Week 24
Standard deviation total sleep time for one week
Measured: Week 24
Sleep Duration Week 6
total sleep time minutes
Measured: Weeks 6
Sleep Duration Week 12
total sleep time in minutes
Measured: Week 12
Sleep Duration Week 24
total sleep time in minutes
Measured: Week 24
HbA1C Week 6
Hemoglobin A1C week 6, %
Measured: Week 6
HbA1C Week 12
HbA1c blood test
Measured: Week 12
HbA1C Week 24
HbA1c blood test
Measured: Week 24

Secondary outcomes (24)

Diabetes Distress Week 6
Type 1 Diabetes Distress Scale measures diabetes distress. Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
Measured: Week 6
Diabetes Distress Week 12
Type 1 Diabetes Distress Scale measures diabetes distress. Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
Measured: Week 12
Diabetes Distress Week 24
Type 1 Diabetes Distress Scale measures diabetes distress. Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
Measured: Week 24
Self-management Behavior Week 6
Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10). Ranges from 0-10. Higher numbers indicate better self-management behavior Unit of measure = units on a scale
Measured: Week 6
Self Management Behavior Week 12
Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10). Scores ranges from 0-10. Higher numbers indicate better self-management behavior Unit of measure = units on a scale
Measured: Week 12
Self Management Behavior Week 24
Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10). Ranges from 0-10. Higher numbers indicate better self-management behavior Unit of measure = units on a scale
Measured: Week 24
Quality of Life Week 6
Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100.
Scores are reverse coded so that higher numbers indicate better quality of life.
Unit of measure = units on a scale
Measured: Week 6
Quality of Life Week 12
Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100.
Scores are reverse coded so that higher numbers indicate better quality of life.
Unit of measure = units on a scale.
Measured: Week 12
Quality of Life Week 24
Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100.
Scores are reverse coded so that higher numbers indicate better quality of life.
Unit of measure = units on a scale.
Measured: Week 24
Fatigue Week 6
Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue.
The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue.
Measured: Week 6
Fatigue Week 12
Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue.
The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue.
Measured: Week 12
Fatigue Week 24
Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue.
The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue.
Measured: Week 24
Mood Week 6
Center for Epidemiological Studies-Depression (CES-D) measures depressive mood. Total summed score ranges from 0-60. Higher scores indicate greater depressive mood. Unit of measure = units on a scale.
Measured: Week 6
Mood Week 12
Center for Epidemiological Studies-Depression (CES-D) measures depressive mood. Total summed score ranges from 0-60. Higher scores indicate greater depressive mood. Unit of measure = units on a scale.
Measured: Week 12
Mood Week 24
Center for Epidemiological Studies-Depression (CES-D) measures depressive mood. Total summed score ranges from 0-60. Higher scores indicate greater depressive mood. Unit of measure = units on a scale.
Measured: Week 24
Subjective Sleep Quality Week 6
Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. Total summed score ranges 0-21. Higher score reflects poorer sleep quality. Unit of measure = units on a scale.
Measured: Week 6
Subjective Sleep Quality Week 12
Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. Total summed score ranges 0-21. Higher score reflects poorer sleep quality. Unit of measure = units on a scale.
Measured: Week 12
Subjective Sleep Quality Week 24
Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. Total summed score ranges 0-21. Higher score reflects poorer sleep quality. Unit of measure = units on a scale.
Measured: Week 24
Glycemic Variability Week 6
Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Measured: Week 6
Glycemic Variability Week 12
Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Measured: Week 12
Glycemic Variability Week 24
Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Measured: Week 24
Glucose Time-in-range Week 6
Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Measured: Week 6
Glucose Time-in-range Week 12
Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Measured: Week 12
Glucose Time-in-range Week 24
Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 202121 Dec 2025

First posted10 Aug 2020
Study start19 Jan 2021
Primary completion21 Dec 2024
Study completion21 Dec 2025

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.
Publications (2)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Sleep optimization intervention will be compared to an attention control group
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04506151
Sponsor's protocol ID: 2020-0374
Other IDs: 1R01DK121726
Acronym: SOPT
Status last verified: Aug 2026
First submitted: 22 Jul 2020
Last updated: 27 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hong SJ, Pratuangtham S, Martyn-Nemeth P, Steffen AD, Park CG, Reutrakul S. Blue Light Exposure During Sleep in Type 1 Diabetes: Impacts on Glycemic Control and Psychosocial Health. J Sleep Res. 2026 Jun 5:e70380. doi: 10.1111/jsr.70380. Online ahead of print.
PubMed 42246173
Martyn-Nemeth P, Duffecy J, Quinn L, Reutrakul S, Steffen AD, Burke L, Clark Withington MH, Irsheed GA, Perez R, Park M, Saleh A, Mihailescu D, Baron KG. Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Trials. 2022 Aug 19;23(1):686. doi: 10.1186/s13063-022-06565-6.
PubMed 35986415

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04506151
Acronym / sponsor ID: SOPT / 2020-0374
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: University of Illinois at ChicagoUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 19 Jan 2021 (actual)
Primary completion: 21 Dec 2024 (actual)
Study completion: 21 Dec 2025 (actual)
First posted: 10 Aug 2020 (actual)
Results: Posted 27 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Sleep optimization intervention will be compared to an attention control group

Arm	Type	Receives
Sleep-Opt	Experimental	Behavioral: Sleep-Opt12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
Healthy Living	Active comparator	Behavioral: Healthy Living12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

adults aged 18-65 years
clinical diagnosis of type 1 diabetes minimum of one year
reported habitual sleep variability (1 hour/week or more) or sleep duration less than 6.5 hrs/night during work- or weekdays (confirmed with actigraphy sleep watch)
a desire to improve sleep
own a smartphone

Key exclusion criteria (9 listed)

insomnia symptoms
at high risk for obstructive sleep apnea
severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness)
A1C greater than 10%
rotating shift or night shift work

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-Opt12-week behavioral intervention	Behavioural	Sleep-Opt
Healthy LivingHealthy Living	Behavioural	Healthy Living

Primary outcome

Sleep Variability Week 6
Time frame: Week 6
Standard deviation total sleep time for one week
Sleep Variability Week 12
Time frame: Week 12
Standard deviation total sleep time for one week
Sleep Variability Week 24
Time frame: Week 24
Standard deviation total sleep time for one week
Sleep Duration Week 6
Time frame: Weeks 6
total sleep time minutes
Sleep Duration Week 12
Time frame: Week 12
total sleep time in minutes
Sleep Duration Week 24
Time frame: Week 24
total sleep time in minutes
HbA1C Week 6
Time frame: Week 6
Hemoglobin A1C week 6, %
HbA1C Week 12
Time frame: Week 12
HbA1c blood test
HbA1C Week 24
Time frame: Week 24
HbA1c blood test

24 secondary outcomes

Diabetes Distress Week 6
Time frame: Week 6
Diabetes Distress Week 12
Time frame: Week 12
Diabetes Distress Week 24
Time frame: Week 24
Self-management Behavior Week 6
Time frame: Week 6
Self Management Behavior Week 12
Time frame: Week 12
Self Management Behavior Week 24
Time frame: Week 24
Quality of Life Week 6
Time frame: Week 6
Quality of Life Week 12
Time frame: Week 12
Quality of Life Week 24
Time frame: Week 24
Fatigue Week 6
Time frame: Week 6
Fatigue Week 12
Time frame: Week 12
Fatigue Week 24
Time frame: Week 24
Mood Week 6
Time frame: Week 6
Mood Week 12
Time frame: Week 12
Mood Week 24
Time frame: Week 24
Subjective Sleep Quality Week 6
Time frame: Week 6
Subjective Sleep Quality Week 12
Time frame: Week 12
Subjective Sleep Quality Week 24
Time frame: Week 24
Glycemic Variability Week 6
Time frame: Week 6
Glycemic Variability Week 12
Time frame: Week 12
Glycemic Variability Week 24
Time frame: Week 24
Glucose Time-in-range Week 6
Time frame: Week 6
Glucose Time-in-range Week 12
Time frame: Week 12
Glucose Time-in-range Week 24
Time frame: Week 24

Results and safety

Results posted to the registry on 27 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sleep-Opt	73	67
Healthy Living	71	67

Primary outcome: Sleep Variability Week 6

Time frame: Week 6. Mean (Standard Deviation). Unit: minutes

Measure	Sleep-Opt n = 59	Healthy Living n = 56
Value	65.92 (31.11)	63.74 (34.81)

Sleep-Opt vs Healthy Living: Median Difference (Final Values): -2.12 (95% CI -13.75 to 9.59)

Primary outcome: Sleep Variability Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: minutes

Measure	Sleep-Opt n = 60	Healthy Living n = 60
Value	65.27 (39.45)	64.06 (29.39)

Sleep-Opt vs Healthy Living: Median Difference (Final Values): -3.62 (95% CI -15.36 to 8.24)

Primary outcome: Sleep Variability Week 24

Time frame: Week 24. Mean (Standard Deviation). Unit: Standard deviation total sleep time (min

Measure	Sleep-Opt n = 59	Healthy Living n = 56
Value	69.41 (29.66)	71.04 (34.27)

Sleep-Opt vs Healthy Living: Median Difference (Final Values): -6.96 (95% CI -18.42 to 4.45)

Primary outcome: Sleep Duration Week 6

Time frame: Weeks 6. Mean (Standard Deviation). Unit: Sleep duration, minutes

Measure	Sleep-Opt n = 59	Healthy Living n = 56
Value	411.53 (47.31)	385.29 (44.96)

Sleep-Opt vs Healthy Living: Median Difference (Final Values): 13.80 (95% CI -0.09 to 27.81)

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sleep-Opt	0 of 73 (0%)	0 of 73 (0%)	0 of 73
Healthy Living	0 of 71 (0%)	0 of 71 (0%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42246173Hong SJ, Pratuangtham S, Martyn-Nemeth P, Steffen AD, Park CG, Reutrakul S. Blue Light Exposure During Sleep in Type 1 Diabetes: Impacts on Glycemic Control and Psychosocial Health. J Sleep Res. 2026 Jun 5:e70380. doi: 10.1111/jsr.70380. Online ahead of print.
Derived from this study: PubMed 35986415Martyn-Nemeth P, Duffecy J, Quinn L, Reutrakul S, Steffen AD, Burke L, Clark Withington MH, Irsheed GA, Perez R, Park M, Saleh A, Mihailescu D, Baron KG. Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Trials. 2022 Aug 19;23(1):686. doi: 10.1186/s13063-022-06565-6.
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.

Pamela Martyn-Nemeth, PhD principal investigator

University of Illinois at Chicago

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-Opt and Healthy Living in people with Type 1 Diabetes, run by University of Illinois at Chicago 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 5 inclusion and 9 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 27 Aug 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 27 Aug 2026). 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?

Sleep Variability Week 6 (time frame: Week 6). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04506151, which also lists 2 linked publications.

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 27 Aug 2026.