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A Sleep Intervention in Type 1 Diabetes

A Sleep Intervention to Improve Glycemic Control and Reduce Diabetes Distress in Working Adults With Type 1 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03617770
Enrollment
14
Registered
2018-08-06
Start date
2019-01-09
Completion date
2019-11-20
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Sleep Phenotype, Type1diabetes

Keywords

type 1 diabetes, glycemic control, sleep, diabetes distress

Brief 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.

Detailed 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.

Interventions

BEHAVIORALSleep Opt-In

8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling

BEHAVIORALHealthy Living

8-week intervention that includes weekly telephone counseling on healthy living.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Chicago
CollaboratorOTHER
University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Sleep optimization intervention will be compared to a healthy living attention control

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep DurationAssessing change between two time points:Week 0 to week 8change in minutes of sleep (actigraphy-derived)
Sleep RegularityAssessing change between two time points: from week 0 to week 8Change in sleep regularity (variability)

Secondary

MeasureTime frameDescription
HbA1cChange between two time points, week 0 to week 8HbA1c (A1C%)
Glucose VariabilityAssessing change between two time points: from week 0 to week 8Change in glucose variability (CV%) (continuous glucose monitor derived)
Diabetes DistressAssessing change between two time points: from week 0 to week 8Change 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Sleep-Opt-In
Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling
9
Healthy Living
Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
5
Total14

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10

Baseline characteristics

CharacteristicHealthy LivingSleep-Opt-InTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants9 Participants14 Participants
Age, Continuous30.0 years
STANDARD_DEVIATION 7.6
30.1 years
STANDARD_DEVIATION 7.1
30.1 years
STANDARD_DEVIATION 7.2
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants3 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants6 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
3 Participants8 Participants11 Participants
Region of Enrollment
United States
5 participants9 participants14 participants
Sex: Female, Male
Female
4 Participants5 Participants9 Participants
Sex: Female, Male
Male
1 Participants4 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 5
other
Total, other adverse events
0 / 90 / 5
serious
Total, serious adverse events
0 / 90 / 5

Outcome results

Primary

Sleep Duration

change in minutes of sleep (actigraphy-derived)

Time frame: Assessing change between two time points:Week 0 to week 8

ArmMeasureValue (MEAN)Dispersion
Sleep-Opt-InSleep Duration385 minutesStandard Deviation 40
Healthy LivingSleep Duration388 minutesStandard Deviation 39
Primary

Sleep Regularity

Change in sleep regularity (variability)

Time frame: Assessing change between two time points: from week 0 to week 8

ArmMeasureValue (MEAN)Dispersion
Sleep-Opt-InSleep Regularity46 minutesStandard Deviation 20
Healthy LivingSleep Regularity56 minutesStandard Deviation 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

Time frame: Assessing change between two time points: from week 0 to week 8

ArmMeasureValue (MEAN)Dispersion
Sleep-Opt-InDiabetes Distress1.2 change in score on a scaleStandard Deviation 0.23
Healthy LivingDiabetes Distress3.1 change in score on a scaleStandard Deviation 1.36
Secondary

Glucose Variability

Change in glucose variability (CV%) (continuous glucose monitor derived)

Time frame: Assessing change between two time points: from week 0 to week 8

ArmMeasureValue (MEAN)Dispersion
Sleep-Opt-InGlucose Variability34.4 percentage of CVStandard Deviation 4.6
Healthy LivingGlucose Variability31.6 percentage of CVStandard Deviation 5
Secondary

HbA1c

HbA1c (A1C%)

Time frame: Change between two time points, week 0 to week 8

ArmMeasureValue (MEAN)Dispersion
Sleep-Opt-InHbA1c6.48 % of glucose saturation on hemoglobinStandard Deviation 0.74
Healthy LivingHbA1c6.7 % of glucose saturation on hemoglobinStandard Deviation 1.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026