Using Wearable Sensors To Understand Low Blood Sugar in Type 1 Diabetes

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06727071
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperglycemic clamp — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2025
Status verified
Dec 2024
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Wearable Sensor Arm
    The intervention is the hyperglycemic clamp. All participants will complete the clamp.

Primary Outcome Measure

Hypoglycemic Clamp Epinephrine Response [ Time Frame: 160 Minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Diego - ACTRILa JollaCalifornia92037
Program Manager
858-246-2169
Robert Thomas, MD, PhD (PRINCIPAL_INVESTIGATOR)

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