Self-Management in Young Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— SLEEPT1D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975230
• Other study ID #: STUDY20201829
• Secondary ID: K99NR018886R00NR
• Status: Completed
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2024
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeated Measures	General Estimating Equation (GEE)	From (T0) baseline through (T3) 90 days post intervention
Primary	Non-dominant wrist-worn actigraph to be worn 24/7 (Spectrum Plus)	Change in sleep duration (longer sleep duration indicates improvement)	From (T0) baseline through (T3) 90 days post intervention
Primary	Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 [trademark]	Change in time in range and glucose variability (More time in range and less glucose variability indicates improvement)	From (T0) baseline through (T3) 90 days post intervention
Secondary	Self-Care Inventory Revised (15-item)	Change in diabetes self-management (higher scores indicate improvement)	From (T0) baseline through (T3) 90 days post intervention
Secondary	10-Minute Psychomotor Vigilance Test on a PVT-192 device	Change in PVT scores (lower score indicates improvement)	From (T0) baseline through (T3) 90 days post intervention
Secondary	Paper-based Trail Making Test parts A and B (Executive Function)	Change in executive function (lower scores indicate improvement)	From (T0) baseline through (T3) 90 days post intervention
Secondary	PROMIS v1.0 (8-item general distress-depression)	Change in general distress (lower scores indicate improvement)	From (T0) baseline through (T3) 90 days post intervention
Secondary	Diabetes Distress Scale (17-item)	Change in diabetes distress (lower scores indicate improvement)	From (T0) baseline through (T3) 90 days post intervention
Secondary	Diabetes Symptom Checklist Revised (34-item)	Change in diabetes physical symptoms (lower scores indicate improvement)	From (T0) baseline through (T3) 90 days post intervention