Clinical Trials Logo

Clinical Trial Summary

Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glucose control and diabetes distress in type 1 diabetes (T1D). Up to 40% of adults with T1D had a sleep duration less than 6-6.5 hours per night. Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glucose control. Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of strategies to improve sleep on diabetes distress, and glucose control is limited. The purpose of this pilot study is to evaluate the effects of a sleep intervention on sleep duration, diabetes distress and glucose control in individuals with T1D and habitual short sleep. A randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed. Eligible participants will be randomly assigned to a sleep intervention group or a control group. Differences between the two groups on the outcomes of sleep duration, diabetes distress and glucose control will be evaluated. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glucose control.


Clinical Trial Description

Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glycemic control and diabetes distress in type 1 diabetes (T1D). Up to 40% of adults with T1D had a sleep duration < 6-6.5 hours per night, either by self-report or objectively assessed actigraphy. Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glycemic control. Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of sleep optimization on sleep, diabetes distress, and glycemic control is limited. The purpose of this pilot and feasibility trial is to evaluate the effects of a T1D-specific sleep optimization intervention (Sleep-Opt-In) on the outcomes of sleep, diabetes distress and glycemic control in individuals with T1D and habitual short sleep. The specific aims are to determine if Sleep-Opt-In will: 1) be feasible and acceptable to the target population; 2) result in improved sleep duration and regularity; 3) result in improved glycemic control; and 4) lower diabetes distress. To achieve these aims, a randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed. Participants will be screened for habitual sleep duration < 6.5 hours per night. Eligible subjects will be randomized to the T1D-Sleep-Opt-In group or attention control group. A one-week run-in period is planned, with baseline measures of sleep (duration and regularity), glycemia (A1C, fructosamine, glycemic variability), and diabetes distress (Diabetes Distress Scale). The T1D-Sleep-Opt-In will entail a novel technology-assisted behavioral sleep extension intervention developed to leverage rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). This technology employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The intervention will be T1D-specific by addressing T1D-related sleep issues such as nocturnal hypoglycemia. The attention control group will participate in a healthy living information program. At completion (Week 8) and post-program (Weeks 12 and 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glycemic control. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03617770
Study type Interventional
Source University of Illinois at Chicago
Contact
Status Completed
Phase N/A
Start date January 9, 2019
Completion date November 20, 2019

See also
  Status Clinical Trial Phase
Completed NCT03886974 - Transition to Adult Care in Type 1 Diabetes
Completed NCT05620251 - Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
Completed NCT03623113 - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes N/A
Active, not recruiting NCT05078658 - Low-carbohydrate Diet in Children With Type 1 Diabetes N/A
Not yet recruiting NCT06018324 - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Completed NCT03177096 - Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes N/A
Not yet recruiting NCT06418269 - The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes N/A
Completed NCT04172077 - Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Recruiting NCT04950634 - Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Completed NCT04450745 - Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients N/A
Completed NCT03165786 - A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes N/A
Terminated NCT04028960 - IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase Phase 2
Recruiting NCT05324488 - Diabetes Registry Graz for Biomarker Research
Completed NCT02984709 - Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes N/A
Completed NCT02984514 - Brown Adipose Tissue in Type 1 Diabetes N/A
Recruiting NCT06372392 - Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps N/A
Recruiting NCT05973799 - Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes N/A
Recruiting NCT03311516 - New Insulin Therapy by Multiwave Bolus N/A
Completed NCT03711656 - Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques N/A