Ultrasound imaging to detect type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and test a new ultrasound imaging method to detect type 1 diabetes by measuring blood flow in the pancreas. Researchers will establish a standard operating procedure for assessing pancreas blood flow speed and volume using a contrast agent. The study will compare these measurements between healthy individuals and those who have recently developed type 1 diabetes, while also evaluating variability in measurements over time. Participants will undergo ultrasound scans at the University of Colorado Hospital after providing informed consent.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado Anschutz, Barbara Davis Center
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Richard KP Benninger, PhD — University of Colorado, Denver
• Study coordinator: Morgan Sooy
• Email: morgan.sooy@cuanschutz.edu
• Phone: 303 724 7526

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Continuous Glucose Monitor Accuracy and Safety in Adults with Type 1 Diabetes

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• Cardiometabolic effects of non-nutritive sweeteners in Type 1 diabetes

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• Wearable continuous glucose and ketone monitor for adults with type 1 diabetes

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• Tirzepatide for obesity in people with type 1 diabetes

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• New real-time continuous glucose monitor accuracy and safety in adults with type 1 diabetes

  This project will test a new real-time continuous glucose monitor to see if its sensor readings match lab venous plasma (YSI) measurements in adults with type 1 diabetes.

  Recruiting Henan University of Science and Technology · Luoyang, Henan · NCT07092761

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.