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Sleep Health Self-Management for Type 1 Diabetes

N/A
Recruiting
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
Have been diagnosed with T1D for at least 1 year (diagnosis confirmed with ICD 10 code + ≥ 2 of the following: <10 years age at dx, positive autoantibodies [GAD65, IA2, ICA, ZnT8], <30 kg/m2 BMI at dx, diabetes ketoacidosis any time, C-peptide < 0.8 ng/mL + associated glucose >80 mg/dL, family history of 1st degree relative)
Have ≥ 1 poor sleep health dimensions (satisfaction: PROMIS > 56; alertness: ESS > 7.5; timing/regularity: >1 hour variability in bed or waketimes; efficiency: <85%; or duration: < 7 hours)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from (t0) baseline thorough (t4) 9 months post intervention
Awards & highlights

Study Summary

This trial focuses on improving sleep health for those with type 1 diabetes to better manage their glycemia and distress symptoms over 9 months.

Who is the study for?
This trial is for young adults aged 18-31 with Type 1 Diabetes who are not meeting their glycemic targets and have at least one issue with sleep health. They must have been diagnosed for over a year, speak English, and be willing to continue any current sleep apnea treatment. People with severe chronic conditions, psychiatric illnesses, untreated sleep apnea, or those unable to follow the study protocol cannot participate.Check my eligibility
What is being tested?
The trial tests a CB-sleep intervention against enhanced usual care in improving sleep health dimensions and diabetes self-management outcomes over nine months. The CB-sleep program includes motivational interviewing techniques tailored to participants' readiness to change their behavior.See study design
What are the potential side effects?
As this is a behavioral intervention focusing on improving sleep habits through counseling rather than medication, typical drug side effects are not expected. However, changes in sleeping patterns could temporarily affect mood or alertness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 1 Diabetes for over a year and meet the additional criteria.
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I have issues with my sleep, such as feeling unsatisfied, alertness problems, irregular sleep times, low efficiency, or sleeping less than 7 hours.
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My blood sugar control is not on target.
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I am between 18 and 31 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from (t0) baseline thorough (t4) 9 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and from (t0) baseline thorough (t4) 9 months 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
Glycemic target-chronic
Sleep Health: *Regularity
Sleep Health: Alertness
+4 more
Secondary outcome measures
Diabetes distress symptoms
General distress symptoms
Glucose variability/time in range

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CB-sleepExperimental Treatment1 Intervention
Initial instruction for the CB-sleep intervention will occur 60-minute telehealth session. The initial action planning session with a sleep report and booster sessions will be interactive and stage matched. The intervention will include an interactive PowerPoint with the participant's clinician sleep report with personalized feedback. They will be encouraged to systematically extend their time in bed by 1 hour and maintain the extension on both weekends and weekdays. Weekly titration will occur according to the following parameters: if sleep efficiency is ≥ 85%, time in bed is increased by 15 minutes per week until a total of a 1 hour increase in time in bed is achieved, if sleep efficiency is <85%, time in bed remains the same. There will be weekly follow-ups (email, phone, text, video chat) and telehealth 4-week booster sessions. Sleep reports generated by the baseline actigraphy report will be shared with participants with brief action planning and goal setting.
Group II: Attention Control Enhanced Usual Care armActive Control1 Intervention
After baseline, the RA assigned to this condition will schedule a 60-minute telehealth appointment to provide instruction for enhanced usual care at the initial consultation visit via contact at T1 (60-minute telehealth session in a private location). The time-balanced follow-up sessions will remain neutral and focused on health perceptions, current plan of care, and relationship building as opposed to the CB-sleep condition's focus on sleep promotion and extension. The RA assigned to the control condition will ask participants to (a) describe how they are doing and (b) ask how confident they are in achieving the goals they have set for themselves. These calls will help to build a relationship with participants to promote study retention. The investigators recognize that participants may obtain self-initiated diabetes self-management in this group, which will vary and will use a Diabetes Self-Management Tracking Form to monitor weekly information acquisition.

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
246,334 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,344 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,602 Total Patients Enrolled

Media Library

CB Sleep Clinical Trial Eligibility Overview. Trial Name: NCT05823142 — N/A
Type 1 Diabetes Research Study Groups: Attention Control Enhanced Usual Care arm, CB-sleep
Type 1 Diabetes Clinical Trial 2023: CB Sleep Highlights & Side Effects. Trial Name: NCT05823142 — N/A
CB Sleep 2023 Treatment Timeline for Medical Study. Trial Name: NCT05823142 — N/A

Frequently Asked Questions

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

Does this trial include participants aged 55 years or older?

"Eligible participants for this clinical trial must be over the age of 18 and younger than 31."

Answered by AI

What is the criteria for eligibility in this clinical trial?

"The current medical trial is open to 248 individuals with type 1 diabetes who are of age (18-31)."

Answered by AI

Is this research endeavor presently recruiting participants?

"Clinicaltrials.gov attests that this trial, initially posted on August 1st 2023 and revised April 19th 2023, is not currently enrolling patients. However, there are 1287 other studies actively recruiting participants at the moment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Self-Management in Young Adults With Type 1 Diabetes 2023
Stephanie Griggs 2023. "Self-Management in Young Adults With Type 1 Diabetes 2023". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05823142.
~165 spots leftby Dec 2027
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