Assessment of Impaired Counterregulatory Hormones and Cardiovascular Risk Using Modern Wearable Sensors in People Living With Type 1 Diabetes.
University of California, San Diego
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.
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 weara…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men and women between the ages of 18 and 75 years old, inclusive, at the time of screening; 2. Females of non-childbearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study; 3. Diagnosed with Type 1 diabetes \>2-year duration based on clinical history or as defined by the current American Diabetes Association (ADA) criteria; 4. Using hybrid closed loop, standard pump, or multiple daily injections; 5. Able to use a Continuous Glucos…
Interventions
- ProcedureHyperglycemic 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.
Location
- University of California, San Diego - ACTRILa Jolla, California