Type 1 Diabetes MellitusWear WOLFNCT06727071
Using Wearable Sensors To Understand Low Blood Sugar in Type 1 Diabetes
A study testing Hyperglycemic clamp in people with Type 1 Diabetes Mellitus, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Hyperglycemic clamp
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%:
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Diego - ACTRI
La Jolla, California, 92037
Program Manager, 858-246-2169, t1dresearch@health.ucsd.edu
Robert Thomas, MD, PhD
About this study
Official title: Assessment of Impaired Counterregulatory Hormones and Cardiovascular Risk Using Modern Wearable Sensors in People Living With Type 1 Diabetes.
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.
Read the detailed description
This is a single-site study using wearable sensor technology (continuous glucose monitor [CGM] and smartwatch actigraphy) to stratify hypoglycemia and cardiovascular risk in patients living with type 1 diabetes.
To carry out this research, 20 local participants with Type 1 Diabetes (T1D) will wear CGM and smartwatches to quantify hypoglycemia, heart rate variability (HRV), and sleep actigraphy for 4 weeks. These data will be correlated with counterregulatory hormone levels collected during hyperinsulinemic-hypoglycemic (HHC) clamp. The 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 with impaired counter-regulation in the clinical setting (Aim 1). How hypoglycemia exposure impacts cardiometabolic health in T1D will also be explored.
Participants will complete ambulatory blood pressure monitoring (ABPM), flow mediated dilation (FMD), reactive hyperemia-peripheral artery tonometry (RH-PAT), HRV assessment via wearable smartwatch, and serum inflammatory and coagulation evaluation before and after hyperinsulinemic-hypoglycemic clamp to investigate the effect of hypoglycemia on these cardiovascular (CV) risk factors (Aim 2,3). Subjects will be monitored for 4 weeks prior, and 1 week after hypoglycemic clamp.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Hyperglycemic clamp
- Keywords
- T1D, Type 1 Diabetes, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperglycemic clampProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Sensor Arm | Other | The intervention is the hyperglycemic clamp. All participants will complete the clamp. Receives: Procedure: Hyperglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic Clamp Epinephrine Response
The change in epinephrine from the start of the clamp to the end as measured in pg/mL.
Measured: 160 Minutes
Secondary outcomes (4)
CGM Time In Range
Percent time between 70-180 mg/dL as measured by continuous glucose monitor.
Measured: 4 weeks
CGM Time Below Range
Percent time <70 mg/dL as measured by continuous glucose monitor.
Measured: 4 weeks
Peripheral Artery Tonometry
Change in peripheral artery tonometry as measured by Endo-PAT score.
Measured: 4 weeks
Brachial Flow Mediated Dilation
Change in brachial artery vasodilation as measured by flow mediated dilation.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Feb 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Robert L Thomas, University of California, San Diego
- Investigators
- Robert Thomas, MD, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727071
- Sponsor's protocol ID
- 810845
- Acronym
- Wear WOLF
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As the funding for this project is coming from an NIH K12 grant, the data is being used as preliminary data for a K23 submission, so there may not be enough information available to be meaningfully shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Impaired Counterregulatory Hormones and Cardiovascular Risk Using Modern Wearable Sensors in People Living With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT06727071
- Acronym / sponsor ID
- Wear WOLF / 810845
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1D, Type 1 Diabetes, Type 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-site study using wearable sensor technology (continuous glucose monitor [CGM] and smartwatch actigraphy) to stratify hypoglycemia and cardiovascular risk in patients living with type 1 diabetes.
To carry out this research, 20 local participants with Type 1 Diabetes (T1D) will wear CGM and smartwatches to quantify hypoglycemia, heart rate variability (HRV), and sleep actigraphy for 4 weeks. These data will be correlated with counterregulatory hormone levels collected during hyperinsulinemic-hypoglycemic (HHC) clamp. The 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 with impaired counter-regulation in the clinical setting (Aim 1). How hypoglycemia exposure impacts cardiometabolic health in T1D will also be explored.
Participants will complete ambulatory blood pressure monitoring (ABPM), flow mediated dilation (FMD), reactive hyperemia-peripheral artery tonometry (RH-PAT), HRV assessment via wearable smartwatch, and serum inflammatory and coagulation evaluation before and after hyperinsulinemic-hypoglycemic clamp to investigate the effect of hypoglycemia on these cardiovascular (CV) risk factors (Aim 2,3). Subjects will be monitored for 4 weeks prior, and 1 week after hypoglycemic clamp.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Sensor Arm | Other | Procedure: Hyperglycemic clampThe intervention is the hyperglycemic clamp. All participants will complete the clamp. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperglycemic clampA 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. | Procedure or surgery | Wearable Sensor Arm |
Primary outcome
Hypoglycemic Clamp Epinephrine Response
Time frame: 160 Minutes
The change in epinephrine from the start of the clamp to the end as measured in pg/mL.
4 secondary outcomes
CGM Time In Range
Time frame: 4 weeks
CGM Time Below Range
Time frame: 4 weeks
Peripheral Artery Tonometry
Time frame: 4 weeks
Brachial Flow Mediated Dilation
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided. As the funding for this project is coming from an NIH K12 grant, the data is being used as preliminary data for a K23 submission, so there may not be enough information available to be meaningfully shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Thomas, MD, PhD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperglycemic clamp in people with Type 1 Diabetes Mellitus, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Program Manager (858-246-2169, t1dresearch@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemic Clamp Epinephrine Response (time frame: 160 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.