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

March 29, 2024 updated by: Rachel Palting, Oregon Health and Science University

The Effect of Automated Insulin Delivery on Sleep Compared to Multiple Daily Injections in Pediatric Patients With Type 1 Diabetes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ines Guttman-Bauman, MD
  • Phone Number: 503-494-8509
  • Email: Guttman@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rachel L Palting, DO
        • Sub-Investigator:
          • Ines Guttman-Bauman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include pediatric patients diagnosed with Type 1 Diabetes ages 6-18 years currently using multiple daily injections combined with a continuous glucose monitor, eligible for an insulin pump. For this pilot study, a sample size of 40 patients with their caregivers, for a total of 80 individuals.

Description

Inclusion Criteria:

i. Diagnosis: Type 1 diabetes for at least 6 months ii. Age: Participants must be aged between 6-18 years at time of enrollment iii. Treatment modality: Participants must be currently receiving treatment for Type 1 Diabetes through multiple daily injections of insulin, with concomitant use of a continuous glucose monitor, with data sharing through Clarity. Participants must be eligible for an insulin pump, based on individual provider discretion.

iv. Smartphone access, ability to download FitBit application. v. Language: Participants and their guardians must be able to understand and communicate in the primary language(s) used for study-related instructions and questionnaires, which include a demographic survey, questions about diabetes history, two surveys regarding patient and caregiver sleep, and a daily sleep diary.

vi. Informed Consent: Participants (if aged 18 or older) or their legal guardians must provide informed consent for participation in the study.

Exclusion Criteria:

i. Diagnosis: Participants with a diagnosis other than Type 1 Diabetes (e.g. Type 2 Diabetes or MODY).

ii. Age: Participants outside the age range of 6 to 18 years. iii. Treatment modality:

  1. Participants currently not receiving multiple daily injections of insulin.
  2. Participants currently not using a continuous glucose monitor. iv. Participants ineligible for an insulin pump. v. No access to smartphone vi. Inadequate language proficiency: Participants or guardians that cannot communicate effectively in the primary study language.

vii. If a participant is otherwise eligible for the study, a modification may be submitted to the IRB to include the participant in the study. However, language barrier is not an obstacle for a patient to receive standard care in the clinic.

viii. Pregnancy: Pregnancy can significantly affect insulin requirements and sleep patterns.

ix. Allergy or Sensitivity: Participants with known allergies or sensitivities to materials used in Fitbit devices or related equipment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Child/parent dyad
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.
Device: Insulin pump
Continuous subcutaneous insulin therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep duration
Time Frame: 4 months
Number of hours and minutes measured by FitBit
4 months
Sleep efficiency
Time Frame: 4 months
The percentage of time spent asleep while in bed, calculated as the ratio of total sleep time to total time spent in bed.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Disturbance Scale for Children
Time Frame: 4 months
Measures sleep disturbances in children and adolescents, with a T-score ranging from 38 to >100
4 months
Promis Short Form 8a
Time Frame: 4 months
Assess sleep disturbances in caregivers, converts a raw score (8-40) to a T-score (30.5-77.5).
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: 4 months
Measures of blood glucose levels during sleep, frequency of hypoglycemic/hyperglycemic events obtained through CGM data.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Rachel L Palting, DO, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00026893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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