Type1diabetes Clinical Trial
Official title:
A Sleep Intervention to Improve Glycemic Control and Reduce Diabetes Distress in Working Adults With Type 1 Diabetes
Verified date | March 2024 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | November 20, 2019 |
Est. primary completion date | November 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - type 1 diabetes for one year or more - self-reported habitual sleep duration less than 6.5 hours per night during work- or weekdays - own a smartphone. Exclusion Criteria: - insomnia - sleep apnea - severe hypoglycemia within past 6 months - treated with an insulin pump with hybrid closed-loop features - rotating shift or night shift work - estimated glomerular filtration rate less than 45 ml/min - heart failure - cirrhosis - chronic obstructive pulmonary disease requiring oxygen - actively treated for cancer or psychiatric problem - history of stroke - pregnant or planning pregnancy - HbA1c 10% or higher. |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep Duration | change in minutes of sleep (actigraphy-derived) | Assessing change between two time points:Week 0 to week 8 | |
Primary | Sleep Regularity | Change in sleep regularity (variability) | Assessing change between two time points: from week 0 to week 8 | |
Secondary | HbA1c | HbA1c (A1C%) | Change between two time points, week 0 to week 8 | |
Secondary | Glucose Variability | Change in glucose variability (CV%) (continuous glucose monitor derived) | Assessing change between two time points: from week 0 to week 8 | |
Secondary | Diabetes Distress | Change in Diabetes Distress Scale score, 6-point, 17-item Likert scale. The 17 items are summed. The sum score is divided by 17 to provide a mean item score. Higher scores indicate greater distress. Score interpretation:
< 2.0 = little distress 2.0-2.9 = moderate distress 3.0 or greater = hah distress |
Assessing change between two time points: from week 0 to week 8 |
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 |