Apply to Trial

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Wearable Sensors for Type 1 Diabetes
(Wear WOLF Trial)

Overseen ByProgram Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Insulin

Must not be taking: Beta-blockers, GLP-1, SGLT-2i, Metformin

Disqualifiers: Pregnancy, Anemia, Pancreatitis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

Yes, you must stop using any diabetes medications other than insulin at least one month before the trial.

Is the use of wearable sensors for type 1 diabetes generally safe?

The safety of insulin pumps, a type of wearable sensor for type 1 diabetes, can be affected by issues like pump failure or user error, which may lead to high or low blood sugar levels. While there is some safety information available, more research and better data sharing are needed to fully understand the long-term safety of these devices.¹ ² ³ ⁴ ⁵

How does the hyperglycemic clamp treatment differ from other treatments for type 1 diabetes?

The hyperglycemic clamp treatment is unique because it involves maintaining a constant high blood sugar level to study insulin secretion and action, which is different from typical diabetes treatments that focus on lowering blood sugar levels. This method is primarily used for research purposes to understand the body's response to glucose and insulin, rather than as a direct treatment for managing diabetes.⁶ ⁷ ⁸ ⁹ ¹⁰

Who Is on the Research Team?

Robert Thomas, MD, PhD

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for up to 20 people with type 1 diabetes interested in monitoring their low blood sugar levels using wearable technology. Participants will need to wear a continuous glucose monitor and smartwatch for four weeks.

Inclusion Criteria

Able to provide written informed consent approved by an Institutional Review Board (IRB)

I use a hybrid closed loop, standard pump, or inject insulin multiple times daily.

Able to use a Continuous Glucose Monitoring (CGM) device

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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

Body Mass Index (BMI) > 35 kg/m2

I am not pregnant or breastfeeding.

See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Participants wear a continuous glucose monitor (CGM) and a smartwatch to collect data on hypoglycemia, heart rate variability, and sleep

4 weeks

Continuous monitoring with wearable devices

Hyperinsulinemic-Hypoglycemic Clamp

Participants undergo a hyperinsulinemic-hypoglycemic clamp to collect counterregulatory hormone levels and assess cardiovascular risk factors

160 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the clamp procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

Hyperglycemic clamp

Trial Overview The study aims to use data from a continuous glucose monitor (CGM) and smartwatch worn by participants to develop a risk score that predicts the likelihood of experiencing low blood sugar episodes in those with type 1 diabetes.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: Wearable Sensor ArmExperimental Treatment1 Intervention

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but users face significant risks from potential errors in insulin delivery, which can lead to serious health issues like hyperglycemia or hypoglycemia.

Current safety evaluations of insulin pumps are inadequate, with limited transparency in reporting adverse events and insufficient long-term data on real-world usage, highlighting the need for improved regulatory practices and more comprehensive research on pump therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.Heinemann, L., Fleming, GA., Petrie, JR., et al.[2018]

The MiniMed™ 670G system with SmartGuard™ technology was safely used at home by 105 children with type 1 diabetes for 3 months, showing no severe hypoglycemia or diabetic ketoacidosis incidents.

Participants experienced significant improvements in glucose control, with a decrease in HbA1c from 7.9% to 7.5% and an increase in time spent within the target glucose range from 56.2% to 65.0%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes.Forlenza, GP., Pinhas-Hamiel, O., Liljenquist, DR., et al.[2022]