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

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how using insulin pumps affects sleep in children and teenagers with type 1 diabetes, as well as their caregivers. The researchers want to find out if insulin pumps help improve sleep, make it worse, or have no impact at all. They’re also interested in how insulin pumps relate to overnight blood sugar control. The study will involve participants answering questions about their diabetes and sleep, wearing a FitBit to track their sleep for two weeks before and after starting the insulin pump, and keeping daily sleep diaries.

To be eligible for this study, participants need to be between 6 and 18 years old, have been diagnosed with type 1 diabetes for at least six months, and currently receive treatment through multiple daily insulin injections along with a continuous glucose monitor. They will need to have access to a smartphone to download the FitBit app and must be able to understand the study instructions in English or another primary language used in the study. The trial is not yet recruiting participants, but if you or someone you know meets these criteria, it could be a valuable opportunity to help understand the impact of insulin pumps on sleep and overall diabetes management.

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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.