← Back to Search

Child/parent dyad for Type 1 Diabetes

N/A
Waitlist Available
Led By Rachel L Palting, DO
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group

Summary

The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research. The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are: Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control? Participants will be asked to: * Complete questionnaires regarding demographic data and diabetes history. * Complete surveys regarding sleep quality before and after starting an insulin pump. * Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump. After 1-2 months after initiation of an insulin pump, participants will be asked again to: * Complete surveys regarding sleep quality * Wear a FitBit during sleep for 2 weeks * Fill out daily sleep diaries over the same 2 week period.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep duration
Sleep efficiency
Secondary study objectives
Promis Short Form 8a
Sleep Disturbance Scale for Children
Other study objectives
Time in range

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Child/parent dyadExperimental Treatment1 Intervention
Study group will consist of 40 participant dyads - a pediatric patient with type 1 diabetes and one of their caregivers. At the beginning of the study, the patient's treatment should consist of multiple daily insulin injections and a continuous glucose monitor, and during this time, sleep will be evaluated through a FitBit and surveys. Then patient will be started on an insulin pump of their choice (Omnipod 5, Tandem, etc), and sleep will be re-evaluated 1-2 months after pump initiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin pump
2020
Completed Phase 2
~3300

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,004 Previous Clinical Trials
7,413,310 Total Patients Enrolled
Rachel L Palting, DOPrincipal InvestigatorOregon Health and Science University
~0 spots leftby Nov 2024