Who is eligible for clinical trial NCT06727071?

Participants must meet the protocol's inclusion criteria for Type 1 Diabetes Mellitus. The stated age range is 18 Years to 75 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06727071 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-12-06

Using Wearable Sensors To Understand Low Blood Sugar in Type 1 Diabetes (NCT06727071)

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

🟡 Not Yet Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: University of California, San Diego

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (14 items).

Location: University of California, San Diego - ACTRI — La Jolla, California

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

Hyperglycemic clamp (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of California, San Diego - ACTRI — La Jolla, California

📞 Contact the Study Coordinator

Phone: (858) 246-2169

Email: t1dresearch@health.ucsd.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Type 1 Diabetes Mellitus clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗