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

Starting soon · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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 facts

Study ID

NCT06727071

Run by

University of California, San Diego

People needed

20

Starts

2025-02-01

Expected to finish

2026-06-30

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%:
• eGFR ≥ 60 mL/min/1.73m²;
• BMI 18.5-35.0 kg/m2 ;
• Able to provide written informed consent approved by an Institutional Review Board (IRB).

You may not qualify if…

• 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;
• Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1, RA, SGLT-2i, Pramlintide, Metformin);
• Women who are pregnant or lactating/breastfeeding;
• Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
• Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent;
• Severe hypoglycemic events or DKA within 3 months;
• Currently using beta-blockers;
• Adrenal insufficiency diagnosis.

Where it is running

• University of California, San Diego - ACTRI — La Jolla, California, United States

Full record on ClinicalTrials.gov

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