A Sleep Intervention in Type 1 Diabetes

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.

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.