Clinical trial NCT06347783: Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes
Official title: The Effect of Automated Insulin Delivery on Sleep Compared to Multiple Daily Injections in Pediatric Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type1diabetes
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep duration
timeFrame: 4 months
measure: Sleep efficiency
timeFrame: 4 months
Secondary outcomes:
measure: Sleep Disturbance Scale for Children
timeFrame: 4 months
measure: Promis Short Form 8a
timeFrame: 4 months
Other outcomes:
measure: Time in range
timeFrame: 4 months
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Rachel L Palting, DO
role: PRINCIPAL_INVESTIGATOR
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