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N/A N=14 Randomized Treatment

A Sleep Intervention in Type 1 Diabetes

Short Sleep Phenotype · Type1diabetes

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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