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

Oregon Health & Science University (OHSU)

Status: Not yet enrolling

Conditions: Type1diabetes

Treatments: Device: Insulin pump

Study type: Observational

Funder types: Other

Identifiers

NCT06347783

STUDY00026893

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

Child/parent dyad

Description:

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:

Device: Insulin pump