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Type 1 DiabetesFREADOMNCT02974309

Family Routines Enhancing Adolescent Diabetes by Optimizing Management

A study testing Sleep Extension and Routine in people with Type 1 Diabetes, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A three month randomized study to examine the potential benefits of sleep extension in tandem with clinical trial on diabetes management in youth with type 1 diabetes. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Sleep Extension and Routine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
1 siteUnited States
Study dates
15 Sep 2017to 30 Jun 2024
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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Type 1 diabetes

Who cannot join

  • neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation
  • not hospitalized within the previous month prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pediatric Endocrinology Clinic

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: Extending Sleep to Improve Glycemic Control in Pediatric Type 1 Diabetes

A three month randomized study to examine the potential benefits of sleep extension in tandem with clinical trial on diabetes management in youth with type 1 diabetes.

Read the detailed description

Type 1 Diabetes (T1DM) is one of the most common chronic medical conditions that occur in children. More than two-thirds of these young patients struggle to maintain optimal glycemic control. On a seemingly unrelated front, insufficient sleep has become a public health crisis as less than 30% of youth achieve the recommended number of hours on school nights. Prior research has supported that sleep disturbances contribute to elevated glucose levels and have a significant impact on memory, attention, and planning. These skills are essential to effective diabetes management. Despite the link between sleep and diabetes, no research has examined the benefits of an intervention to help these youth achieve a healthy sleep duration. To that end, our primary objective is to determine the effect of sleep extension on glycemic control and psychosocial functioning. Our secondary objective is to determine mediators and moderators of effect. The central hypothesis is that an increase in sleep duration will lower glucose levels and improve behavioral ratings (internalizing, externalizing, and classroom behaviors). Our primary study aims are to (1) Test if lengthening sleep improves glycemic control and psychosocial function in youth with T1DM; (2) Assess putative mechanisms for the effects of sleep extension on glucose and psychosocial function; and (3) Examine the possible moderating effect of pre-existing sleep parameters and sociodemographic variables that modify the impact of sleep extension. A secondary aim is exploratory to examine additional pre-selected mediators and moderators. In the proposed randomized study, up to 175 youth with T1DM will be assigned to a Sleep Extension or a supportive routines condition. The Sleep Extension lengthens youth's time in bed to allow for a healthy sleep duration on a consistent basis, whereas the supportive routines condition reinforces daytime and nighttime activities. We will test the impact of sleep extension on key indices of glycemic control (average glucose levels and % time hyperglycemia using continuous glucose monitors and HbA1C) as well as putative mechanisms of effect (e.g., heart rate variability and salivary cortisol levels) and participant characteristics that might mitigate the benefits of sleep extension (e.g., sleep-disordered breathing, adherence, and SES). Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.

Conditions
Type 1 Diabetes
Being tested
Sleep Extension, Routine
Keywords
Youth, Diabetes Management, Sleep
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 ExtensionBehavioural

    All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer

  • RoutineBehavioural

    All youth in this condition are asked to follow the routines set by their clinical care team.

Study groups in NCT02974309
Study groupRoleWhat they receive
Sleep ExtensionExperimentalAll youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer.
Receives: Behavioral: Sleep Extension
RoutineSham comparatorAll youth in this condition are asked to follow the routine that their clinical team has established.
Receives: Behavioral: Routine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    A measure of glucose control

    Measured: 3 months

Secondary outcomes (2)
  1. Glucose Levels via continuous glucose monitor

    Glucose levels will be measured at regular intervals using a subcutaneous continuous glucose monitor

    Measured: 1 and 3 months

  2. Sleep Duration

    Sleep duration will be measured using a combination of wrist actigraphy and polysomnography data.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2016 (estimated)
  2. Study start15 Sep 2017
  3. Primary completion31 Mar 2024
  4. Study completion30 Jun 2024

Resources

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
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02974309
Sponsor's protocol ID
RDK110528A
Acronym
FREADOM
Status last verified
Jun 2024
First submitted
27 Apr 2016
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon request.

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Extension and Routine in people with Type 1 Diabetes, run by University of Arizona 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 1 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 27 Nov 2024. 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. Some participants in this study may receive a placebo. 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?

HbA1c (time frame: 3 months). 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 27 Nov 2024.

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