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Circadian Mechanisms, Glucose, and CV Risks in T1D

Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With 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 50 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 how a more regular sleep schedule affects blood sugar control and risks to heart and blood vessel health. It is for adults ages 18–50 with type 1 diabetes who have irregular sleep and want to improve it.

People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known. The investigators propose to conduct a mechanistic study using a sleep stability manipulation. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.

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 18–50 years old and have been diagnosed with type 1 diabetes for at least 1 year.
  • You report that your usual sleep schedule varies by at least 1 hour per week.
  • You want to improve your sleep and own an Android phone or iPhone.

Who can't join

  • You report an A1C result of 10% or higher in the past 6 months. A1C measures average blood sugar.
  • You score 15 or higher on the Insomnia Severity Index, a survey about trouble sleeping, or have a history of restless leg syndrome (an urge to move your legs).
  • In the past 6 months, low blood sugar caused you to pass out, have a seizure, or need an emergency room visit or hospital stay.
  • You work rotating shifts or nights, or usually go to sleep after 3 a.m.
  • You use sleep medicines or aids, or have major health problems. Examples include heart failure, liver scarring, lung disease needing oxygen, current cancer treatment, dialysis (treatment that filters your blood), or a past stroke with lasting nerve or brain problems.
  • You score 15 or higher on the PHQ-8, a depression survey.
  • You are pregnant, breastfeeding, or planning to become pregnant.
  • You are allergic to lidocaine, a numbing medicine.

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

Official eligibility criteria

Inclusion Criteria: * Adults 18-50 years with a clinical diagnosis of T1D for at least one year * Report habitual sleep irregularity ≥1 hour/week * Desire to improve sleep, and own a smartphone (Android or iPhone) Exclusion Criteria: * Self-reported A1C within the past 6 months ≥10% * insomnia symptoms defined as Insomnia Severity Index score ≥15 * history of restless leg syndrome * history of severe hypoglycemia (defined as hypoglycemic episode that results in loss of consciousness, seizure, or requiring emergency room visit or hospitalization) within the past 6 months * rotating shift or night work or routinely sleeping after 3 AM. * use of sleep medications/aids, significant medical comorbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, on renal replacement therapy \[dialysis\]) * depression (Patient Health Questionnaire 8 \[PHQ-8\] score ≥15) * history of stroke with neurological deficits * pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding. * Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC

Study sites (1)

IL