Pancreas Ultrasound Imaging in Type 1 Diabetes

This study aims to develop a new way to detect type 1 diabetes using ultrasound imaging of the pancreas. Researchers will first figure out the best way to measure blood flow in the pancreas using an ultrasound and a drug called Definity Suspension for Injection. Then, they will see if blood flow in the pancreas is different in healthy people compared to those who recently developed type 1 diabetes. They will also look at how much these measurements change over time and between different people. You may be able to join if you are 18-65 years old and do not have certain other pancreatic conditions. The study is currently recruiting participants.

Study design: This is an observational study with a planned enrollment of 50 participants. It is divided into two parts, with the first part involving 5 subjects and the second involving 45 subjects.
What's involved: You would visit the study center, have an intravenous line (IV) placed, and receive a conventional ultrasound followed by an ultrasound with Definity. You would also need to fast for about 6 hours before your visit.
Compensation: Not stated in the trial record.
Follow-up: Primary outcomes will be measured at 6 months for Part I and at 1 year for Part II.

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Pancreas Ultrasound Imaging in type1 Diabetes

Recruiting

Not specifiedAges 18–65Observational

University of Colorado, Denver

~50 participants

Updated 2026-05-06 on ClinicalTrials.gov

What's tested:Definity Suspension for Injection

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Primary outcome 1

Measured over End of part I (6 months)

+3 more outcomes measured

Conditions

Type1diabetes

Insulitis

Pancreas Inflamed

Where it's being run

1 sites across 1 states

Colorado1

Study leadership

Richard KP Benninger, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Morgan Sooy

[email protected]

303 724 7526

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or non-pregnant female age 18-65

Ability and willingness of patient to participate fully in all aspects of this clinical study

Written informed consent obtained and documented

Diagnosis of diabetes according to the ADA recommended criteria (blood glucose and HbA1c will be measured)

Evidence of autoantibodies to at least 1 of the following β-cell autoantigens:

Presence of insulin autoantibody will only be valid if taken within the first 14 days of diagnosis.

Diagnosis of diabetes within 180 days prior to participation in the study

Exclusion

Excessive body size preventing effective scan of the pancreas as determined by sonographer

Evidence of exocrine pancreatic disease, including pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumor.

Subjects who are pregnant or breast-feeding

Subjects incapable of giving assent/informed written consent

Known or suspected hypersensitivity to perflutren

Known history or suspected unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)

Diagnosis of diabetes according to the ADA recommended criteria (blood glucose and HbA1c will be measured)

Use of medications used to control high blood sugar (GLP1R agonists, metformin\*, sulfonylureas)

\*Participants taking metformin will be considered eligible if they are willing/able to stop taking the medication for at least two weeks prior to each scan.

Any person who has received immunomodulatory intervention within 3 months of enrollment

Use of medications used to control high blood sugar (GLP1R agonists, metformin\*, sulfonylureas)

\*Participants taking metformin will be considered eligible if they are willing/able to stop taking the medication for at least two weeks prior to each scan.

Any person who has received immunomodulatory intervention within 3 months of enrollment

What this trial measures

Primary outcome 1End of part I (6 months)
Optimized a contrast-enhanced ultrasound 'destruction-replenishment' protocol for imaging pancreas blood flow kinetics in adult human subjects.
Primary outcome 2End of part II (1 year)
Comparison of pancreas blood flow kinetics (i.e. 'destruction-replenishment' k2 'reperfusion rate' parameter) between control and T1D subjects.
Primary outcome 3End of part II (1 year)
Determining inter-subject variability in pancreas blood flow kinetics (i.e. the 'destruction-replenishment' k2 'reperfusion rate' parameter) among control subjects and among T1D subjects
Primary outcome 4End of part II (1 year)
Determining reproducibility in the measurement of pancreas blood flow kinetics (i.e. the 'destruction-replenishment' k2 'reperfusion rate' parameter) within subjects. This will initially focus on short-term intra-subject measurement variability.

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