N/A
N=14
A Sleep Intervention in Type 1 Diabetes
Short Sleep Phenotype · Type1diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03617770 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Sleep Duration — 385; 388 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Opt-In (Behavioral); Healthy Living (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Duration |
385; 388 | — |
| PRIMARY Sleep Regularity |
46; 56 | — |
| SECONDARY HbA1c |
6.48; 6.7 | — |
| SECONDARY Glucose Variability |
34.4; 31.6 | — |
| SECONDARY Diabetes Distress |
1.2; 3.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03617770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.