Trial Outcomes & Findings for Self-Management in Young Adults With Type 1 Diabetes (NCT NCT04975230)

NCT ID: NCT04975230

Last Updated: 2026-01-12

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
• Results posted on: 2026-01-12

Participant Flow

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.

Participant milestones

Measure	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).	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.
Overall Study STARTED	21	18
Overall Study Completed Intervention	21	18
Overall Study COMPLETED	20	13
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-Management in Young Adults With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Sleep Self-Management n=21 Participants 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).	Diabetes Self-Management Education n=18 Participants 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.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=210 Participants	18 Participants n=19 Participants	39 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Age, Continuous	20.95 years STANDARD_DEVIATION 2.16 • n=210 Participants	21.22 years STANDARD_DEVIATION 2.39 • n=19 Participants	21.08 years STANDARD_DEVIATION 2.24 • n=8 Participants
Sex: Female, Male Female	13 Participants n=210 Participants	10 Participants n=19 Participants	23 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=210 Participants	8 Participants n=19 Participants	16 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=210 Participants	2 Participants n=19 Participants	2 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=210 Participants	16 Participants n=19 Participants	37 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=210 Participants	0 Participants n=19 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=210 Participants	4 Participants n=19 Participants	7 Participants n=8 Participants
Race (NIH/OMB) White	16 Participants n=210 Participants	13 Participants n=19 Participants	29 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=210 Participants	1 Participants n=19 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Region of Enrollment United States	21 participants n=210 Participants	18 participants n=19 Participants	39 participants n=8 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Sleep Self-Management n=21 Participants 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).	Diabetes Self-Management Education n=18 Participants 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.
Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)	18 min per night Standard Error 0.17	-25.8 min per night Standard Error 0.17

PRIMARY outcome

Timeframe: 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]

Outcome measures

Measure	Sleep Self-Management n=19 Participants 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).	Diabetes Self-Management Education n=14 Participants 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.
Time in Range 70-180 mg/dL	0.82 percentage of time Standard Error 4.35	-0.35 percentage of time Standard Error 5.07

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sleep Self-Management n=21 Participants 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).	Diabetes Self-Management Education n=18 Participants 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.
Diabetes Self-Management Questionnaire (27-item)	0 score on a scale Standard Error 1.40	0.44 score on a scale Standard Error 1.65

SECONDARY outcome

Timeframe: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

Population: intention to treat analysis - baseline values carried forward.

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.

Outcome measures

Measure	Sleep Self-Management n=21 Participants 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).	Diabetes Self-Management Education n=18 Participants 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.
Paper-based Trail Making Test Parts A and B (Executive Function)	-2.93 time in seconds Standard Error 0.79	-0.92 time in seconds Standard Error 0.84

SECONDARY outcome

Timeframe: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

Population: Intention to treat, baseline values carried forward

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.

Outcome measures

Measure	Sleep Self-Management n=21 Participants 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).	Diabetes Self-Management Education n=18 Participants 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.
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form	1.17 score on a scale Standard Error 2.06	-0.34 score on a scale Standard Error 2.41

SECONDARY outcome

Timeframe: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

Population: intention to treat analysis

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

Outcome measures

Measure	Sleep Self-Management n=21 Participants 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).	Diabetes Self-Management Education n=18 Participants 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.
Diabetes Distress Scale (17-item)	-3.01 score on a scale Standard Error 3.03	-2.22 score on a scale Standard Error 2.35

SECONDARY outcome

Timeframe: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

Population: intention to treat analysis

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

Outcome measures

Measure	Sleep Self-Management n=21 Participants 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).	Diabetes Self-Management Education n=18 Participants 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.
Diabetes Symptom Checklist Revised (34-item)	0 score on a scale Standard Error 0.08	-0.13 score on a scale Standard Error 0.09

OTHER_PRE_SPECIFIED outcome

Timeframe: From (T0) baseline through (T3) 90 days post intervention

Population: The 10-Minute Psychomotor Vigilance Test on a PVT-192 device could not be administered/analysis completed for any enrolled participant due to hardware malfunction and lack of manufacturer technical assistance. The manufacturer was unable to provide timely support due to pandemic-related constraints. Data is not available now nor will it be available in the future.

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.

Outcome measures

Outcome data not reported

Adverse Events

Sleep Self-Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetes Self-Management Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Griggs

Case Western Reserve University

Phone: 404-544-9915

Email: stephanie.griggs2@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place