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

Summary

This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Conditions4

Locations1 site

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