NCT02974309

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 27, 2024

Status Verified

June 1, 2024

Enrollment Period

6.5 years

First QC Date

April 27, 2016

Last Update Submit

November 25, 2024

Conditions

Type 1 Diabetes

Keywords

YouthDiabetes ManagementSleep

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    A measure of glucose control

    3 months

Secondary Outcomes (2)

  • Glucose Levels via continuous glucose monitor

    1 and 3 months

  • Sleep Duration

    3 months

Other Outcomes (5)

  • Diabetes Self-Management

    1 and 3 months

  • Adherence to Diabetes Management

    1 and 3 months

  • Polysomnographic Sleep Architecture

    1 and 3 months

  • +2 more other outcomes

Study Arms (2)

Sleep Extension

EXPERIMENTAL

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

Behavioral: Sleep Extension

Routine

SHAM COMPARATOR

All youth in this condition are asked to follow the routine that their clinical team has established.

Behavioral: Routine

Interventions

Sleep ExtensionBEHAVIORAL

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

Sleep Extension
RoutineBEHAVIORAL

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

Routine

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Type 1 diabetes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Endocrinology Clinic

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michelle M Perfect, PhD

    UA College of Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

November 28, 2016

Study Start

September 15, 2017

Primary Completion

March 31, 2024

Study Completion

June 30, 2024

Last Updated

November 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Upon request.

Locations

US(1)