Using Wearable Sensors To Understand Low Blood Sugar in Type 1 Diabetes
NCT06727071 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-12-10
Summary
This is a single-site study using wearable sensor technology (CGM and smartwatch) to better explain low blood sugars in patients living with type 1 diabetes.
Up to 20 participants with T1D will wear a continuous glucose monitor (CGM) and a smartwatch to collect information about hypoglycemia (low blood sugar), heart rate variability (HRV), and sleep for 4 weeks. The main goal is to create a hypoglycemia risk score using wearable sensor metrics that can be easily applied to all patients with T1D to identify those at greater risk of hypoglycemia.
Conditions
- Type 1 Diabetes Mellitus
Interventions
- PROCEDURE
-
Hyperglycemic clamp
A continuous infusion of 20% dextrose will be maintained throughout the procedure, while a variable rate of insulin infusion will be used to control participants blood glucose level.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
University of California, San Diego
lead OTHER
Principal Investigators
-
Robert Thomas, MD, PhD · UC San Diego
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2026-03-31
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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