NCT06727071

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

Assessment of Impaired Counterregulatory Hormones and Cardiovascular Risk Using Modern Wearable Sensors in People Living With Type 1 Diabetes.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-site study using wearable sensor technology (continuous glucose monitor \[CGM\] and smartwatch actigraphy) to stratify hypoglycemia and cardiovascular risk in patients living with type 1 diabetes. To carry out this research, 20 local participants with Type 1 Diabetes (T1D) will wear CGM and smartwatches to quantify hypoglycemia, heart rate variability (HRV), and sleep actigraphy for 4 weeks. These data will be correlated with counterregulatory hormone levels collected during hyperinsulinemic-hypoglycemic (HHC) clamp. The 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 with impaired counter-regulation in the clinical setting (Aim 1). How hypoglycemia exposure impacts cardiometabolic health in T1D will also be explored. Participants will complete ambulatory blood pressure monitoring (ABPM), flow mediated dilation (FMD), reactive hyperemia-peripheral artery tonometry (RH-PAT), HRV assessment via wearable smartwatch, and serum inflammatory and coagulation evaluation before and after hyperinsulinemic-hypoglycemic clamp to investigate the effect of hypoglycemia on these cardiovascular (CV) risk factors (Aim 2,3). Subjects will be monitored for 4 weeks prior, and 1 week after hypoglycemic clamp.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-03-31
• Completion: 2026-06-30
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

1 site across 1 country: United States