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Sleep for Health Study: Insomnia Treatment and Diabetes Risk

This study is looking at whether treating insomnia can help lower blood sugar levels in people who have prediabetes (blood sugar levels higher than normal, but not yet diabetes). You might be able to join if you are between 22 and 79 years old, have prediabetes and insomnia, and have internet access. The study will compare an interactive online program called SHUTi, which teaches cognitive behavioral therapy for insomnia (CBT-I), to a basic patient education website. Researchers will measure your blood sugar levels to see if the insomnia treatment helps reduce your risk of developing type 2 diabetes. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 300 participants. Participants will be randomly assigned to receive either the SHUTi program or a patient education website.
What's involved
You would have blood sugar measurements taken at the start of the study, after 11 weeks, and again after 33 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 33 weeks after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06067139

Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Recruiting
NAAges 22–79InterventionalTreatment
Kaiser Permanente
~300 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:SHUTiPatient Education

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2-hour post-load glucose (2hPG) (mg/dL)
Measured over V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)

Conditions

Diabetes Mellitus, Type 2
Prediabetic State
Sleep Initiation and Maintenance Disorders

Explore related trials

Disorders of initiating and maintaining sleepPrediabetes

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Erin LeBlanc, MD · PRINCIPAL_INVESTIGATOR · Kaiser Permanente

Who to contact

Stefan Massimino, MS
[email protected]
971-232-9343
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Age ≥ 22 years and \< 80 years of age
Prediabetes
Insomnia
Regular access to device with internet access
Adequate data at baseline

Exclusion

BMI \> 40 kg/m2
Sleep comorbidities detected in medical record or via medical history
Shift work or significant, externally imposed irregular sleep schedule
moderate to severe OSA by home sleep apnea test as part of trial protocol
Received a full course of CBT-I in the last 12 months
Current use of medication with glycemic effects:
History of type 1 or type 2 diabetes or recent/planned use of hypoglycemic agents (e.g., metformin, insulin)
Recent history of bariatric surgery or planning bariatric surgery in the next year
Current or recent use of weight loss meds
Unstable sleep medication regimen (recent change to schedule or dosage)
Significant comorbidity that may interfere with CBT-I uptake or increase risks
Unwilling or unable to limit heavy machinery use/long bouts of driving or unstable illness that would be worsened by sleep restriction
High risk of falls
Epilepsy
Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use)
Significant alcohol or substance use disorder
Active or recent history of eating disorder, recent weight change of \>10%
Women: pregnancy (current or planned), breastfeeding, \< 1 year postpartum
Use of hydroxyurea
Extensive skin changes or adhesive allergy making CGM sensor use problematic

What this trial measures

  • 2-hour post-load glucose (2hPG) (mg/dL)V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)

    2-hour post-load glucose (mg/dL)