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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how wearable technology, like continuous glucose monitors (CGM) and smartwatches, can help us understand low blood sugar (hypoglycemia) in people with type 1 diabetes (T1D). Over the course of four weeks, up to 20 participants will wear these devices to collect data about their blood sugar levels, heart rates, and sleep patterns. The goal is to develop a simple risk score that can help identify which patients may be more likely to experience low blood sugar, allowing for better management of their condition.

To be eligible for this study, participants need to be between 18 and 75 years old and have a diagnosis of type 1 diabetes for at least two years. They should be using insulin for their diabetes management, either through a pump or multiple daily injections, and have a specific range of blood sugar control (A1c levels between 7% and 10%). Participants will be required to provide informed consent and follow the study protocol. This research aims to improve safety and understanding of hypoglycemia in individuals living with type 1 diabetes, making it an important step in diabetes care.

Gender

ALL

Eligibility criteria

• 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 Glucose Monitoring (CGM) device;
• 6. A1c \> 7% and ≤ 10%:
• • 7. eGFR ≥ 60 mL/min/1.73m²;
• • 8. BMI 18.5-35.0 kg/m2 ;
• • 9. Able to provide written informed consent approved by an Institutional Review Board (IRB).
• Exclusion Criteria:
• • 1. 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;
• 2. History of pancreatitis, medullary thyroid carcinoma or liver disease:
• • 3. Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
• • 4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
• • 5. Body Mass Index (BMI) \> 35 kg/m2;
• • 6. 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;
• • 7. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1, RA, SGLT-2i, Pramlintide, Metformin);
• • 8. Women who are pregnant or lactating/breastfeeding;
• • 9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
• • 10. 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;
• • 11. Severe hypoglycemic events or DKA within 3 months;
• • 12. Currently using beta-blockers;
• • 13. Adrenal insufficiency diagnosis.