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 — PROCEDUREA 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 ArmThe intervention is the hyperglycemic clamp. All participants will complete the clamp.
Primary Outcome Measure
Hypoglycemic Clamp Epinephrine Response [ Time Frame: 160 Minutes ]
Central Contacts
- Program Manager858-246-2169
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Diego - ACTRI | La Jolla | California | 92037 | Robert Thomas, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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