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Sleep Self-Management for Type 1 Diabetes (SLEEPT1D Trial)

N/A
Waitlist Available
Led By Stephanie Griggs, PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age range: from 18 to 26 years
Diagnosed with T1D for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from (t0) baseline through (t3) 90 days post intervention
Awards & highlights

SLEEPT1D Trial Summary

This trial is testing whether a sleep self-management intervention can help young adults with type 1 diabetes improve their sleep and glycemic control.

Who is the study for?
This trial is for young adults aged 18-26 with Type 1 Diabetes who have an A1C level of ≥7%, can read/speak English, and aren't part of other studies. They shouldn't have major health issues, be pregnant, diagnosed with sleep apnea, or work night shifts.Check my eligibility
What is being tested?
The study tests a cognitive-behavioral sleep self-management program aimed at extending sleep and stabilizing bedtime routines against standard diabetes education. The goal is to see if better sleep improves blood sugar control in short-sleeping young adults with T1D.See study design
What are the potential side effects?
Since the intervention focuses on behavioral changes related to sleep habits rather than medication, side effects are minimal but may include temporary discomfort adjusting to new sleeping patterns.

SLEEPT1D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be between 18 and 26 years old.
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You have been diagnosed with type 1 diabetes for at least 6 months.

SLEEPT1D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from (t0) baseline through (t3) 90 days post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and from (t0) baseline through (t3) 90 days post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Repeated Measures
Secondary outcome measures
10-Minute Psychomotor Vigilance Test on a PVT-192 device
Diabetes Distress Scale (17-item)
Diabetes Symptom Checklist Revised (34-item)
+3 more

SLEEPT1D Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep Self-ManagementExperimental Treatment1 Intervention
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.
Group II: Diabetes Self-Management EducationActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Self-Management
2022
N/A
~50

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,638 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
260,043 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
575 Previous Clinical Trials
10,355,529 Total Patients Enrolled

Media Library

Type 1 Diabetes Research Study Groups: Diabetes Self-Management Education, Sleep Self-Management

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum participant rate for this clinical research?

"Affirmative. The information available on clinicaltrials.gov indicates that the research study is still recruiting, having first been posted on April 29th 2022 and most recently updated May 17th of the same year. 48 participants will be admitted to this single site trial."

Answered by AI

Is eligibility restricted to persons over the age of 75 for this clinical experiment?

"To be included in this medical trial, applicants must have aged between 18 and 25 years old. For individuals under 18 years of age or over 65 there are 218 and 925 respective clinical trials currently available."

Answered by AI

What criteria are being utilized to select individuals for this medical research?

"The requirements to enroll are that patients must be 18-25 years old and have a diagnosis of diabetes mellitus. This study is only admitting 48 individuals total."

Answered by AI

Is there still room to participate in this investigation?

"Correct. The clinicaltrials.gov website reveals that this research endeavor, which was first published on April 29th 2022, is actively recruiting volunteers. 48 individuals are needed to be enlisted from a single site."

Answered by AI

To what end is this scientific experiment striving?

"The core purpose of this trial, beginning at the baseline (T0) through 90 days post-intervention (T3), is to assess repeated measurements. Secondary goals involve utilizing PROMIS v1.0 and examining any alterations in general distress levels; additionally, a paper-based Trail Making Test for both parts A & B will be administered with an aim to gauge executive function changes; finally, a 10 minute Psychomotor Vigilance Test on PVT 192 device intends to examine shifts in corresponding scores from these tests - lower values signalling improvement."

Answered by AI
~15 spots leftby Mar 2025