Type 1 Diabetes MellitusNCT03397147
Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
A study testing Sleep Coach Jr. in people with Type 1 Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Sleep Coach Jr.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 9 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child between 5-9 years of age
- child have been diagnosed with type 1 diabetes for at least 12 months
- caregiver lives with child
- caregiver can read/speak English
Who cannot join
- child has other major health problems or sleep disorders other than insufficient sleep or insomnia
- participating in other intervention studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Sleep Coach Jr.
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Coach Jr.Behavioural
A brief sleep education program for parents of school-aged children with type 1 diabetes, with a focus on resolving sleep disturbances with parent education and positive bedtime routines.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care |
| Sleep Coach Jr. | Experimental | Parents randomized to the intervention condition will receive a binder with the treatment manual, and the intervention will be administered in person (first session) and via telephone (second session) on an individual basis. The first session will focus on parent education and developing a positive bedtime routines, and the second session will be used to address barriers specific to the individual child. Receives: Behavioral: Sleep Coach Jr. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Sleep Duration
Child sleep duration (measured with actigraphy)
Measured: 3 months
Child Sleep Quality
Child sleep quality (measured with Child Sleep Habits Questionnaire)
Measured: 3 months
Secondary outcomes (7)
Glycemic Control
HbA1c, % glucose values in range
Measured: 3 months
Parent Sleep Duration
Parent sleep duration (measured with actigraphy)
Measured: 3 months
Parental Well-being
Well-Being Index (World Health Organization Five Well-Being Index, WHO-5)
Measured: 3 months
Child Behavior Problems
Behavior problems measured with the Child Behavior Checklist (CBCL)
Measured: 3 months
Parent Sleep Quality
and sleep quality (measured with Pittsburgh Sleep Quality Index)
Measured: 3 months
Parental Fear of Hypoglycemia
Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale)
Measured: 3 months
Parental Diabetes Distress
Diabetes distress (Problem Area In Diabetes - Parental Version Revised)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start5 Jul 2018
- Primary completion1 Apr 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial with 2 conditions (intervention and usual care).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Jaser, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397147
- Sponsor's protocol ID
- 171902
- Status last verified
- Mar 2020
- First submitted
- 2 Jan 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
- ClinicalTrials.gov ID
- NCT03397147
- Acronym / sponsor ID
- 171902
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial with 2 conditions (intervention and usual care).
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care |
| Sleep Coach Jr. | Experimental | Behavioral: Sleep Coach Jr.Parents randomized to the intervention condition will receive a binder with the treatment manual, and the intervention will be administered in person (first session) and via telephone (second session) on an individual basis. The first session will focus on parent education and developing a positive bedtime routines, and the second session will be used to address barriers specific to the individual child. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child between 5-9 years of age
- child have been diagnosed with type 1 diabetes for at least 12 months
- caregiver lives with child
- caregiver can read/speak English
Key exclusion criteria (2 listed)
- child has other major health problems or sleep disorders other than insufficient sleep or insomnia
- participating in other intervention studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Coach Jr.A brief sleep education program for parents of school-aged children with type 1 diabetes, with a focus on resolving sleep disturbances with parent education and positive bedtime routines. | Behavioural | Sleep Coach Jr. |
Primary outcome
Child Sleep Duration
Time frame: 3 months
Child sleep duration (measured with actigraphy)
Child Sleep Quality
Time frame: 3 months
Child sleep quality (measured with Child Sleep Habits Questionnaire)
7 secondary outcomes
Glycemic Control
Time frame: 3 months
Parent Sleep Duration
Time frame: 3 months
Parental Well-being
Time frame: 3 months
Child Behavior Problems
Time frame: 3 months
Parent Sleep Quality
Time frame: 3 months
Parental Fear of Hypoglycemia
Time frame: 3 months
Parental Diabetes Distress
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Coach Jr. in people with Type 1 Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Sleep Duration (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.