Self-Management in Young Adults With Type 1 Diabetes

Sleep, Glycemia, and Self-Management in Young Adults With Type 1 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04975230

Acronym

SLEEPT1D

Enrollment

Registered

2021-07-23

Start date

2022-04-29

Completion date

2023-11-01

Last updated

2026-01-12

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

Conditions

Type 1 Diabetes

Keywords

Young Adult

Brief summary

Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C \<7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. Modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with T1D. Therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population. The overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.

Detailed description

This is a two-arm randomized controlled trial, with participants assigned to either the Sleep Self-Management arm or the attention control arm (Diabetes Self-Management Education). The Sleep Self-Management condition involves an initial 50-minute face-to-face consultation with brief 5-10 minute weekly follow-ups in a format TBD by aim 1 (e.g., call, text, video conference) with 3-week booster sessions in person. The Sleep Self-Management intervention activities are provided in addition to usual care.

Interventions

BEHAVIORALSleep Self-Management

Intervention delivered by a sleep coach will include 1) initial in-person 50 min consultation; 2) brief 5 min weekly follow ups in a format TBD; and 3) in-person 30 min booster sessions every 3 weeks (total 13 sessions).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Masking description

Both conditions will receive time-balanced sessions with the study team. Participants will not be told whether in the experimental condition or the condition delivering usual care until after the completion of the study.

Intervention model description

Behavioral: Sleep self-management

Eligibility

Sex/Gender

ALL

Age

18 Years to 26 Years

Healthy volunteers

Inclusion criteria

* 1\) Age range: from 18 to 26 years * 2\) Diagnosed with T1D for at least 6 months * 3\) No other major health problems (e.g., chronic medical condition or major psychiatric illness * 4\) Not currently participating in any intervention studies * 5\) Read/speak English * 6\) Have a most recent A1C or eA1C value ≥ 7%.

Exclusion criteria

* 1\) Previous OSA diagnosis/high-risk sleep apnea * 2\) Current pregnancy * 3\) Night shift workers * 4\) Habitually sleep \> 7 hours on work or school days.

Design outcomes

Primary

Measure	Time frame	Description
Time in Range 70-180 mg/dL	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in time in range 70-180mg/dL over the monitoring period (7-14 days). Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 \[trademark\]
Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Average sleep duration as assessed as the average minutes per night participants spent asleep over the 7-14 days preceding each time point (Change in sleep duration (longer sleep duration indicates improvement).

Secondary

Measure	Time frame	Description
Paper-based Trail Making Test Parts A and B (Executive Function)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in executive function (lower scores indicate improvement). The Trail Making Test (TMT) consists of two parts, A and B, which assess performance/cognitive function as the time taken to complete each part in seconds. In Part A, numbered circles (1-25) are connected in ascending order as quickly as possible. In Part B, circles are connected in ascending order with the added task of alternating between numbers and letters (1-A-2-B, etc.). Both parts are summed and scored based on the time taken to complete the task, with higher scores (longer time) indicating greater cognitive impairment.
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in general distress (lower scores indicate improvement). The Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form is an 8-item instrument to assess depression symptoms. Each item is scored on a 5-point Likert scale from 1 (Never) to 5 (Always). Total raw scores range from 8-40 with higher scores indicating greater depressive symptoms.
Diabetes Symptom Checklist Revised (34-item)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in diabetes physical symptoms (lower scores indicate improvement). The Diabetes Symptom Checklist Revised (DSC-R) is a 34-item checklist to assess type 2 diabetes symptom burden using a 5-point Likert scale ranging from 0 (Not at all) to 5 (Extremely) with a total score range of 0-170 where higher scores indicate increased symptom burden
Diabetes Distress Scale (17-item)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in diabetes distress (lower scores indicate improvement). The Diabetes Distress Scale (DDS) is a 17-item tool to measure emotional distress as experienced by individuals living with diabetes. Each item is scored on a 6-point Likert scale from 1 (Not a Problem) to 6 (A Very Serious Problem) with a total score range of 17-102
Diabetes Self-Management Questionnaire (27-item)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in Diabetes Self-Management Questionnaire (DSMQ) scores. The DSMQ is a 27-item scale assessing behaviors and activities related to diabetes self-management. Each item is scored on a 4-point Likert scale from 0 (does not apply to me) to 3 (applies to me very much), and items scores are summed/transformed to a total score (range 0 to 10) reflecting overall diabetes self-management, with higher scores indicating better self-management skills (better outcome). This outcome represents the change in scores from baseline to post intervention. Diabetes self-management is an ongoing process where individuals actively manage their condition to maintain optimal blood sugar levels, prevent complications, and improve their overall quality of life.

Other

Measure	Time frame	Description
10-Minute Psychomotor Vigilance Test on a PVT-192 Device	From (T0) baseline through (T3) 90 days post intervention	Change in Psychomotor Vigilance Test (PVT) score. The PVT as administered by the PVT-192 device (Ambulatory Monitoring) measures reaction time to assess alertness as an effect of sleep deprivation. Reactions are measure in time by seconds, where lower time scores in seconds indicating greater levels of alertness.

Countries

United States

Participant flow

Recruitment details

This research was a single-center randomized controlled trial carried out at Case Western Reserve University between April 2022 and October 2023. Participants were recruited from Diabetes Specialty Clinics from University Hospitals Cleveland Medical Center.

Participants by arm

Arm	Count
Sleep Self-Management The Sleep Self-Management Intervention involves an initial 50-minute face-to-face interactive session in a private location. Participants are asked to extend time in bed by 1 hour and consistently maintain the extension on both weekends and weekdays. Bedtimes and waketimes will be assessed to ascertain which time is most modifiable for the participant's lifestyle and routine. There will be weekly follow-ups and in-person 3-week booster sessions. Sleep reports generated by the actigraphy will be shared with participants with brief action planning and goal setting to address progress towards goal achievement. A need to revise plans for future weeks will be the booster sessions' major goal. Sleep Self-Management: Intervention delivered by a sleep coach will include 1) initial in-person 50 min consultation; 2) brief 5 min weekly follow ups in a format TBD; and 3) in-person 30 min booster sessions every 3 weeks (total 13 sessions).	21
Diabetes Self-Management Education The Attention Control arm will receive Diabetes Self-Management Education at the initial consultation visit via in-person contact at T1. There will be weekly follow-ups and in-person 3-week sessions. A Diabetes Self-Management Tracking Form will be used to monitor the weekly acquisition of information and plans for the 6-week intervention and at the 3-month and 6-month data points.	18
Total	39

Baseline characteristics

Characteristic	Sleep Self-Management	Diabetes Self-Management Education	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	21 Participants	18 Participants	39 Participants
Age, Continuous	20.95 years STANDARD_DEVIATION 2.16	21.22 years STANDARD_DEVIATION 2.39	21.08 years STANDARD_DEVIATION 2.24
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants	16 Participants	37 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	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	3 Participants	4 Participants	7 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	2 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	16 Participants	13 Participants	29 Participants
Region of Enrollment United States	21 participants	18 participants	39 participants
Sex: Female, Male Female	13 Participants	10 Participants	23 Participants
Sex: Female, Male Male	8 Participants	8 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 18
other Total, other adverse events	0 / 21	0 / 18
serious Total, serious adverse events	0 / 21	0 / 18

Outcome results

Primary

Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)

Average sleep duration as assessed as the average minutes per night participants spent asleep over the 7-14 days preceding each time point (Change in sleep duration (longer sleep duration indicates improvement).