Bubble ultrasound could spot type 1 diabetes before it strikes
NCT ID NCT05482321
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new ultrasound method that uses tiny, safe bubbles to measure blood flow in the pancreas. The goal is to see if changes in blood flow can help detect type 1 diabetes early, before symptoms appear. Researchers will compare 50 healthy adults and people recently diagnosed with type 1 diabetes. If successful, this could lead to a simple, non-invasive screening tool for early detection.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Group 1 subjects will be healthy subjects who will receive contrast-enhanced ultrasound 'destruction-replenishment' measurements, in order to optimize and establish the standard operating procedure (SOP) for this measurement in the pancreas of human subjects. This SOP will then be applied to Group 2 (healthy subjects and autoantibody positive subjects) and Group 3 (recent onset type1 diabetes) subjects as part of the cross-sectional study. Classification of type 1 diabetes includes meeting ADA criteria for diabetes, within 180 days of diagnosis, and evidence of at least 1 islet-associated autoantibody.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
All Participants: Inclusion Criteria: * 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 Exclusion Criteria: * 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) Group 2 (control subjects, part II): Inclusion criteria: No additional inclusion criteria Exclusion criteria: * 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 Group 3 (T1D subjects, part II) Inclusion criteria: * 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: insulin, IA-2, GAD65, ZnT8 * 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 criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Anschutz, Barbara Davis Center
RECRUITINGAurora, Colorado, 80045, United States
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