RightFit
RecruitingEarly Phase 1

CBTi for the Treatment of Insomnia in Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether sleep therapy helps adults with type 1 diabetes and insomnia (trouble sleeping). It will compare sleep therapy with a healthy living program to see if therapy improves sleep, blood sugar, mood, and tiredness.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 65 years old.
  • You have had type 1 diabetes for at least 1 year.
  • You use a continuous glucose monitor, a device that tracks blood sugar.
  • You have poor sleep quality.
  • You can attend 3 office visits.

Who can't join

  • You are pregnant or breastfeeding, or plan to be.
  • You work night shifts or shifts that change.
  • You have a high risk of obstructive sleep apnea, when your airway gets blocked during sleep.
  • You cannot take part in therapy or answer questionnaires in English.
  • You take sleep medicines or stimulant medicines for ADHD, or use illegal drugs.
  • You have moderately severe or severe depression.
  • You have heart failure, cirrhosis (liver scarring), COPD (a long-term lung disease), an illness needing oxygen, or kidney failure needing dialysis (a treatment that cleans your blood).
  • You are being treated for cancer or mental health problems, have lasting nerve or brain problems from a stroke, or have problems with memory or thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Study sites (1)

IL