Circadian Mechanisms, Glucose, and CV Risks in T1D
ConditionType 1 Diabetes (T1D)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sleep stability intervention
BehavioralThe sleep stability intervention will consist of three theory-based intervention components our team has developed and used in prior interventions: 1) self-monitoring using a wearable sleep tracker (Fitbit). This is well-liked by participants and increases awareness of their sleep goals. 2) Accountability coaching via weekly check-ins and daily monitoring of participants' wearable sleep tracking data and a coaching protocol.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single armOther 1 intervention
Trial outcomes
Primary outcomes
1
Glycemic status
Continuous glucose monitor (CGM)
Time frame
From enrollment to week 122
Glycemic control
Hemoglobin A1C
Time frame
From enrollment to week 123
Insulin sensitivity
Insulin sensitivity
Time frame
From enrollment to week 12Secondary outcomes
1
Circadian regulation DLMO
dim-light melatonin onset (DLMO)
Time frame
enrollment to week 122
Circadian regulation Melatonin
Melatonin metabolite amplitude
Time frame
Enrollment to week 123
Circadian regulation actigraphy
actigraphy-derived rest activity rhythm
Time frame
enrollment to week 124
Circadian regulation CLOCK gene
endothelial cell CLOCK gene mRNA expression
Time frame
enrollment to week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov