Wearable Sensors for Type 1 Diabetes

(Wear WOLF Trial)

Overseen By Program 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how wearable technology can assist people with type 1 diabetes in managing low blood sugar levels. Participants will use a continuous glucose monitor (CGM) and a smartwatch to track their blood sugar, heart rate, and sleep over four weeks. The researchers aim to create a risk score to identify individuals at greater risk of dangerous low blood sugar events. This trial may suit those who have had type 1 diabetes for more than two years, use insulin therapy, and have an A1c level of 7-10%. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance diabetes management for many.

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.

What prior data suggests that these wearable sensors are safe for monitoring Type 1 Diabetes?

Research has shown that the hyperglycemic clamp, used in this study, is generally safe and well-tolerated by participants. Previous studies found no major safety issues with this method. The hyperglycemic clamp manages blood sugar levels to observe the body's reactions. Commonly used in diabetes research, this technique has been safely applied in the past.

Participants in earlier studies did not experience serious side effects from the clamp procedure, indicating a low risk. However, as with any medical procedure, discussing any concerns with the study team before joining is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of hyperglycemic clamps with wearable sensors for managing Type 1 Diabetes because it offers a new way to closely monitor and control blood sugar levels. Unlike traditional methods that rely on periodic blood tests and insulin injections, this approach uses continuous monitoring to provide real-time data, helping to maintain optimal glucose levels more effectively. This method could lead to more precise and personalized diabetes management, potentially reducing the risk of long-term complications associated with the disease.

What evidence suggests that this wearable sensor technology is effective for managing type 1 diabetes?

Studies have shown that hyperglycemic clamps precisely and accurately measure how well the body uses sugar. This method helps researchers understand insulin resistance, a condition where the body doesn't respond well to insulin. Research has indicated that insulin resistance can be problematic for people with type 1 diabetes. In this trial, all participants will undergo the hyperglycemic clamp procedure. By using this method, doctors can study these patterns more effectively and potentially find ways to predict and prevent low blood sugar episodes. This could lead to better management for patients with type 1 diabetes. ^{2 5 6 7 8}

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 use a Continuous Glucose Monitoring (CGM) device

A1c > 7% and ≤ 10%

eGFR ≥ 60 mL/min/1.73m²

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.

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?

Group I: Wearable Sensor Arm Experimental Treatment 1 Intervention

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

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

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]

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]

Wearable continuous glucose monitoring (CGM) sensors provide near real-time blood glucose measurements, significantly improving diabetes management for insulin-dependent individuals by enhancing safety and effectiveness of therapy.

CGM devices help reduce the incidence and duration of hypoglycemia, decrease glycemic variability, and support better insulin dosage decisions, showcasing their beneficial impact on diabetes treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications. Cappon, G., Vettoretti, M., Sparacino, G., et al.[2020]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6692813/

Iatrogenic Hyperinsulinemia, Not Hyperglycemia, Drives ... High-dose insulin infusion stimulated glucose disposal similarly in control subjects and GCK-MODY but was 29% and 22% less effective in type 1 diabetes, ...

2. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16487

No evidence from euglycaemic–hyperinsulinaemic clamp ... No evidence from euglycaemic–hyperinsulinaemic clamp studies for greater insulin sensitivity in adults with type 1 diabetes using insulin pump ...

3. academic.oup.com academic.oup.com/edrv/article/46/3/317/8042119

Insulin Resistance in Type 1 Diabetes - Oxford Academic This review discusses the mechanisms, clinical features, and therapeutic relevance of insulin resistance by focusing mainly on human studies ...

4. journals.physiology.org journals.physiology.org/doi/abs/10.1152/ajpendo.00598.2020

Precision and accuracy of hyperglycemic clamps in a ... The Restoring Insulin Secretion (RISE) study centers undertook hyperglycemic clamps using a simplified methodology and a decision guidance algorithm ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1347436715300525

Pharmacokinetic/Pharmacodynamic Modeling of Glucose ... Published data from two studies in 11 healthy volunteers and 18 type 1 diabetes patients were digitized. The subjects received four different doses of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7898688/

A single‐dose euglycaemic clamp study in two cohorts to ... All treatments were well tolerated and there were no relevant differences in safety variables among treatments. The single‐dose, crossover ...

7. diabetesjournals.org diabetesjournals.org/diabetes/article/68/8/1565/39654/Iatrogenic-Hyperinsulinemia-Not-Hyperglycemia

Iatrogenic Hyperinsulinemia, Not Hyperglycemia, Drives ... Iatrogenic hyperinsulinemia, not hyperglycemia, drives insulin resistance in type 1 diabetes as revealed by comparison with GCK-MODY (MODY2).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01060917

Glucose Clamp Study to Prove Hypo- and Hyperglycemic ... The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (300 mg/dL) for 1.5 h, and euglycemia (100 ...