NCT06727071
Using Wearable Sensors To Understand Low Blood Sugar in Type 1 Diabetes
Not Yet Recruiting · Not Applicable · University of California, San Diego · registry updated 2024-12-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Men and women between the ages of 18 and 75 years old, inclusive, at the time of screening;
- 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;
- Diagnosed with Type 1 diabetes \>2-year duration based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
- Using hybrid closed loop, standard pump, or multiple daily injections;
- Able to use a Continuous Glucose Monitoring (CGM) device;
- A1c \> 7% and ≤ 10%:
Exclusion
- History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
- History of pancreatitis, medullary thyroid carcinoma or liver disease:
- Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
- Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
- Body Mass Index (BMI) \> 35 kg/m2;
- Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;