Diabetes Mellitus Type 1Early Phase 1NCT07091318
CBTi for the Treatment of Insomnia in Type 1 Diabetes
A Early Phase 1 study testing Sleep quality improvement therapy and Healthy Living in people with Diabetes Mellitus Type 1 and Insomnia, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 1, Insomnia
- What is being tested?
- Sleep quality improvement therapy and Healthy Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Between 18 to 65 years old
- Have been diagnosed with Type 1 Diabetes for at least a year
- Use a continuous glucose monitor
- Have poor sleep quality
- Able to attend 3 office visits
Who cannot join
- Currently or planning pregnancy or breast feeding
- Employed with a rotating or night shift
- Are at a high risk for obstructive sleep apnea
- Non-English speaking (unable to participate in therapy or questionnaire).
- Take medications for sleep
- moderately severe to severe depression
- Have a significant medical history that includes conditions like heart failure, cirrhosis, COPD, diseases requiring oxygen, active treatment for cancer or psychiatric problems, history of stroke with neurological deficits, cognitive impairment, kidney failure that requires dialysis, illicit drug use, use of ADHD stimulant medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Jennifer Duffecy, PhD, 312-413-1225, jduffecy@uic.edu
About this study
The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include:
Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?
Read more
Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.
Participants in the therapy intervention group will:
- meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.
Participants in the healthy living group will:
- receive weekly health education emails
- receive brief weekly calls from a coach to answer any questions
Participants, regardless of intervention, over the 12 week study period will:
- monitor their sleep for 2 weeks through a sleep-monitoring watch
- share their continuous glucose monitoring data throughout the study
- answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
- attend 3 in person office visits
- Conditions
- Diabetes Mellitus Type 1, Insomnia
- Being tested
- Sleep quality improvement therapy, Healthy Living
- Keywords
- insomnia, diabetes, sleep, adults, type 1 diabetes, stress, A1c
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Initiation and Maintenance Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep quality improvement therapyBehavioural
8 virtual CBTi sessions will be provided through a therapist weekly for the first four weeks and every other week for the last eight weeks of the study.
Healthy LivingBehavioural
Health education emails and brief coaching calls will be provided weekly. The phone coaches will not provide counseling or goal setting but can clarify what participants had questions on like terms and concepts.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy Intervention for Insomnia | Experimental | Virtual CBTi sessions will be tailored to be address the specific challenges that come with type 1 diabetes. Receives: Behavioral: Sleep quality improvement therapy |
| Healthy Living | Active comparator | Psychoeducation about general health and sleep alongside brief calls from a coach will be provided. Receives: Behavioral: Healthy Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Will be measured via the Acceptability of Intervention Measure (AIM) at the end of the interventions. AIM is measured through 4 questions on a scale of 1-5 resulting in scores from 4 to 20 points. The higher the score the higher the acceptability.
Measured: From enrollment to the end of the intervention (12 weeks)
Secondary outcomes (5)
Glycemic Variability
Assessed as time in, above or below range as collected by the continuous glucose monitor.
Measured: Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a questionnaire that assesses sleep quality and disturbances within the last month. It consists of 18 questions that either have scaled questions with four options or asks the participant for input regarding factors like bed time, time to fall asleep, hours of sleep etc. Each participant answer, both on the scale and on input, is assigned a score between 0 and 3. Thus, the score range goes from 0 to 54, with a higher score indicating worse sleep quality.
Measured: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)
Glycemic Control
Assessed through A1C
Measured: Week 0 (baseline) and Week 12 (end of treatment)
Sleep duration
Measured by actigraphy watch
Measured: Week 0 (baseline) and Week 12 (end of treatment)
Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance
The PROMIS questionnaire assesses self-reported sleep quality through the lens of depth and restoration. It contains 8 questions regarding the last 7 days and is scored on a scale of 1 to 5 for each question. The scores range from 8 to 40. A higher score indicates worse sleep quality.
Measured: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the treatment group or the control group.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091318
- Sponsor's protocol ID
- 2024-0987
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to individual data will be restricted to the principle investigator and authorized members of the research team-- who will be trained on data confidentiality and how to handle secure data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBTi for the Treatment of Insomnia in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07091318
- Acronym / sponsor ID
- 2024-0987
- Conditions
- Diabetes Mellitus Type 1, Insomnia
- Keywords
- insomnia, diabetes, sleep, adults, type 1 diabetes, stress, A1c
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include:
Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?
Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.
Participants in the therapy intervention group will:
- meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.
Participants in the healthy living group will:
- receive weekly health education emails
- receive brief weekly calls from a coach to answer any questions
Participants, regardless of intervention, over the 12 week study period will:
- monitor their sleep for 2 weeks through a sleep-monitoring watch
- share their continuous glucose monitoring data throughout the study
- answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
- attend 3 in person office visits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the treatment group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Intervention for Insomnia | Experimental | Behavioral: Sleep quality improvement therapyVirtual CBTi sessions will be tailored to be address the specific challenges that come with type 1 diabetes. |
| Healthy Living | Active comparator | Behavioral: Healthy LivingPsychoeducation about general health and sleep alongside brief calls from a coach will be provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18 to 65 years old
- Have been diagnosed with Type 1 Diabetes for at least a year
- Use a continuous glucose monitor
- Have poor sleep quality
- Able to attend 3 office visits
Key exclusion criteria (7 listed)
- Currently or planning pregnancy or breast feeding
- Employed with a rotating or night shift
- Are at a high risk for obstructive sleep apnea
- Non-English speaking (unable to participate in therapy or questionnaire).
- Take medications for sleep
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 quality improvement therapy8 virtual CBTi sessions will be provided through a therapist weekly for the first four weeks and every other week for the last eight weeks of the study. | Behavioural | Cognitive Behavioral Therapy Intervention for Insomnia |
| Healthy LivingHealth education emails and brief coaching calls will be provided weekly. The phone coaches will not provide counseling or goal setting but can clarify what participants had questions on like terms and concepts. | Behavioural | Healthy Living |
Primary outcome
Acceptability
Time frame: From enrollment to the end of the intervention (12 weeks)
Will be measured via the Acceptability of Intervention Measure (AIM) at the end of the interventions. AIM is measured through 4 questions on a scale of 1-5 resulting in scores from 4 to 20 points. The higher the score the higher the acceptability.
5 secondary outcomes
Glycemic Variability
Time frame: Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)
Glycemic Control
Time frame: Week 0 (baseline) and Week 12 (end of treatment)
Sleep duration
Time frame: Week 0 (baseline) and Week 12 (end of treatment)
Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance
Time frame: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Access to individual data will be restricted to the principle investigator and authorized members of the research team-- who will be trained on data confidentiality and how to handle secure data.
Related trials for Diabetes Mellitus Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sleep quality improvement therapy and Healthy Living in people with Diabetes Mellitus Type 1 and Insomnia, run by University of Illinois 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 7 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: looking for participants now, as of the sponsor's last update on 6 Oct 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Duffecy, PhD (312-413-1225, jduffecy@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: From enrollment to the end of the intervention (12 weeks)). 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 6 Oct 2026.