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Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes

NCT06347783 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

  • Type1diabetes

Interventions

DEVICE

Insulin pump

Continuous subcutaneous insulin therapy.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Rachel L Palting, DO · Oregon Health and Science University

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2024-11-15
Completion
2024-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06347783 on ClinicalTrials.gov