Trial Outcomes & Findings for A Sleep Intervention in Type 1 Diabetes (NCT NCT03617770)

NCT ID: NCT03617770

Last Updated: 2024-03-06

Results Overview

change in minutes of sleep (actigraphy-derived)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Assessing change between two time points:Week 0 to week 8
• Results posted on: 2024-03-06

Participant Flow

Participant milestones

Measure	Sleep-Opt-In Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
Overall Study STARTED	9	5
Overall Study COMPLETED	8	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Sleep-Opt-In Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

A Sleep Intervention in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Sleep-Opt-In n=9 Participants Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living n=5 Participants Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.1 years STANDARD_DEVIATION 7.1 • n=5 Participants	30.0 years STANDARD_DEVIATION 7.6 • n=7 Participants	30.1 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	5 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessing change between two time points:Week 0 to week 8

change in minutes of sleep (actigraphy-derived)

Outcome measures

Measure	Sleep-Opt-In n=5 Participants Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living n=3 Participants Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
Sleep Duration	385 minutes Standard Deviation 40	388 minutes Standard Deviation 39

PRIMARY outcome

Timeframe: Assessing change between two time points: from week 0 to week 8

Change in sleep regularity (variability)

Outcome measures

Measure	Sleep-Opt-In n=5 Participants Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living n=3 Participants Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
Sleep Regularity	46 minutes Standard Deviation 20	56 minutes Standard Deviation 8

SECONDARY outcome

Timeframe: Change between two time points, week 0 to week 8

HbA1c (A1C%)

Outcome measures

Measure	Sleep-Opt-In n=5 Participants Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living n=3 Participants Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
HbA1c	6.48 % of glucose saturation on hemoglobin Standard Deviation 0.74	6.7 % of glucose saturation on hemoglobin Standard Deviation 1.4

SECONDARY outcome

Timeframe: Assessing change between two time points: from week 0 to week 8

Change in glucose variability (CV%) (continuous glucose monitor derived)

Outcome measures

Measure	Sleep-Opt-In n=5 Participants Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living n=3 Participants Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
Glucose Variability	34.4 percentage of CV Standard Deviation 4.6	31.6 percentage of CV Standard Deviation 5.0

SECONDARY outcome

Timeframe: Assessing change between two time points: from week 0 to week 8

Change in Diabetes Distress Scale score, 6-point, 17-item Likert scale. The 17 items are summed. The sum score is divided by 17 to provide a mean item score. Higher scores indicate greater distress. Score interpretation:

< 2.0 = little distress 2.0-2.9 = moderate distress 3.0 or greater = hah distress

Outcome measures

Measure	Sleep-Opt-In n=5 Participants Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling	Healthy Living n=3 Participants Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
Diabetes Distress	1.2 change in score on a scale Standard Deviation 0.23	3.1 change in score on a scale Standard Deviation 1.36

Adverse Events

Sleep-Opt-In

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Living

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

Dr. Pamela Martyn-Nemeth

University of Illinois at Chicago

Phone: 3129967903

Email: pmartyn@uic.edu

Results disclosure agreements

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