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Sleep Extension for Type 1 Diabetes (FREADOM Trial)

N/A

Recruiting

Led By Michelle M Perfect, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 1 diabetes

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 3 months

Awards & highlights

FREADOM Trial Summary

This trial is to see if extending sleep can help manage diabetes in youth.

Who is the study for?

This trial is for young people with Type 1 diabetes. It's not suitable for those who have had a recent hospital stay or have neurological, developmental, or psychiatric conditions that could affect sleep or participation in the study.Check my eligibility

What is being tested?

The study is testing if adding more sleep to daily routines can help manage Type 1 diabetes better in youth. Participants will be randomly assigned to either extend their sleeping hours or continue with their usual routine over three months.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like sleep extension and routine adjustments, side effects are minimal but may include changes in mood, alertness, or daytime fatigue due to alterations in sleep patterns.

FREADOM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have type 1 diabetes.

FREADOM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HbA1c

Secondary outcome measures

Glucose Levels via continuous glucose monitor

Sleep Duration

Other outcome measures

Adherence to Diabetes Management

Cortisol

Diabetes Self-Management

+2 more

FREADOM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sleep ExtensionExperimental Treatment1 Intervention

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

Group II: RoutinePlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Extension

2017

N/A

~400

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,096 Total Patients Enrolled

Michelle M Perfect, PhDPrincipal InvestigatorUA College of Education

1 Previous Clinical Trials

114 Total Patients Enrolled

Media Library

Sleep Extension Clinical Trial Eligibility Overview. Trial Name: NCT02974309 — N/A

Type 1 Diabetes Research Study Groups: Sleep Extension, Routine

Type 1 Diabetes Clinical Trial 2023: Sleep Extension Highlights & Side Effects. Trial Name: NCT02974309 — N/A

Sleep Extension 2023 Treatment Timeline for Medical Study. Trial Name: NCT02974309 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accommodate participants aged forty or above?

"Consistent with the trial requirements, the participant pool is limited to minors aged 10-17."

Answered by AI

What is the upper limit of participants enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this research has been opened for recruitment since September 15th 2017 and was last updated on June 29th 2022. 175 test subjects are needed from 2 different medical facilities."

Answered by AI

Is there an opportunity for me to participate in the trial?

"Applicants must suffer from diabetes mellitus and be between 10 and 17 years old in order to join this clinical trial. A total of 175 candidates are sought by the research team."

Answered by AI

Are there any openings remaining in this clinical experiment?

"Affirmative, this clinical trial is actively enrolling participants. The study was initially listed on September 15th 2017 and last updated June 29th 2022. 175 people located at 2 sites are required to complete the research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Family Routines Enhancing Adolescent Diabetes by Optimizing Management

2017. "Family Routines Enhancing Adolescent Diabetes by Optimizing Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02974309.