Short Sleep Phenotype, Type1diabetes
Conditions
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
8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling
8-week intervention that includes weekly telephone counseling on healthy living.
Sponsors
Study design
Intervention model description
Sleep optimization intervention will be compared to a healthy living attention control
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Duration | Assessing change between two time points:Week 0 to week 8 | change in minutes of sleep (actigraphy-derived) |
| Sleep Regularity | Assessing change between two time points: from week 0 to week 8 | Change in sleep regularity (variability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Change between two time points, week 0 to week 8 | HbA1c (A1C%) |
| Glucose Variability | Assessing change between two time points: from week 0 to week 8 | Change in glucose variability (CV%) (continuous glucose monitor derived) |
| Diabetes Distress | Assessing change between two time points: from week 0 to week 8 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Healthy Living | Sleep-Opt-In | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 14 Participants |
| Age, Continuous | 30.0 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 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 11 Participants |
| Region of Enrollment United States | 5 participants | 9 participants | 14 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 5 |
| other Total, other adverse events | 0 / 9 | 0 / 5 |
| serious Total, serious adverse events | 0 / 9 | 0 / 5 |
Outcome results
Sleep Duration
change in minutes of sleep (actigraphy-derived)
Time frame: Assessing change between two time points:Week 0 to week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep-Opt-In | Sleep Duration | 385 minutes | Standard Deviation 40 |
| Healthy Living | Sleep Duration | 388 minutes | Standard Deviation 39 |
Sleep Regularity
Change in sleep regularity (variability)
Time frame: Assessing change between two time points: from week 0 to week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep-Opt-In | Sleep Regularity | 46 minutes | Standard Deviation 20 |
| Healthy Living | Sleep Regularity | 56 minutes | Standard Deviation 8 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep-Opt-In | Diabetes Distress | 1.2 change in score on a scale | Standard Deviation 0.23 |
| Healthy Living | Diabetes Distress | 3.1 change in score on a scale | Standard Deviation 1.36 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep-Opt-In | Glucose Variability | 34.4 percentage of CV | Standard Deviation 4.6 |
| Healthy Living | Glucose Variability | 31.6 percentage of CV | Standard Deviation 5 |
HbA1c
HbA1c (A1C%)
Time frame: Change between two time points, week 0 to week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep-Opt-In | HbA1c | 6.48 % of glucose saturation on hemoglobin | Standard Deviation 0.74 |
| Healthy Living | HbA1c | 6.7 % of glucose saturation on hemoglobin | Standard Deviation 1.4 |