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

NCT06727071 | Not Yet Recruiting

• 1 other identifier: 810845
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

T1D; Type 1 Diabetes; Type 1

Outcome Measures

Primary Outcomes (1)

• Hypoglycemic Clamp Epinephrine Response

  The change in epinephrine from the start of the clamp to the end as measured in pg/mL.

  160 Minutes

Secondary Outcomes (4)

• CGM Time In Range

  4 weeks

• CGM Time Below Range

  4 weeks

• Peripheral Artery Tonometry

  4 weeks

• Brachial Flow Mediated Dilation

  4 weeks

Study Arms (1)

Wearable Sensor Arm

OTHER

The intervention is the hyperglycemic clamp. All participants will complete the clamp.

Procedure: Hyperglycemic clamp

Interventions

Hyperglycemic clamp PROCEDURE

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.

Wearable Sensor Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of California, San Diego - ACTRI

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert Thomas, MD, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Manager

CONTACT

858-246-2169; t1dresearch@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: February 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

US (1)