NCT05482321

Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes

Recruiting now Last updated 4 May 2026

What this trial tests

trial testing Definity Suspension for Injection in Type1diabetes in 50 participants. Currently enrolling.

Timeline

27 February 2023

Primary endpoint
1 September 2026

1 September 2026

Quick facts

Lead sponsor	University of Colorado, Denver
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	50
Start date	27 February 2023
Primary completion	1 September 2026
Estimated completion	1 September 2026
Sites	1 location across United States

Drugs / interventions tested

• Definity Suspension for Injection — full drug profile →

Conditions studied

• Type1diabetes — all drugs for Type1diabetes →
• Insulitis — all drugs for Insulitis →
• Pancreas Inflamed — all drugs for Pancreas Inflamed →

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 65, any sex, with Type1diabetes or Insulitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Primary outcome 1
  Time frame: End 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 2
  Time frame: End 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 3
  Time frame: End 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 4
  Time frame: End 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.

Sponsor's own description

The overall goal of this study is to develop and test a novel method involving ultrasound imaging, in order to detect the development of type 1 diabetes. In this study the investigators will first establish a standard operating procedure for measuring pancreas blood flow speed and volume in the pancreas of human subjects. The investigators will then determine 1) whether these pancreas blood flow factors differ between healthy subjects and those who have recently developed type1 diabetes; and 2) how variable measurements are in healthy subjects and subjects that recently developed type1 diabetes, both between subjects and over time. To address these aims the investigators will perform pancreas ultrasound measurements in each subject using an approved injectable 'bubble' contrast agent that allows measurement of pancreas blood flow. The investigators will compare ultrasound measurement with characteristics of the subject's type 1 diabetes, including genetic factors, glucose levels and other circulating factors, as well as other factors that may influence blood flow in the pancreas independent of type1 diabetes. The successful conclusion of this study will indicate whether measuring pancreas blood flow speed/volume will be helpful in monitoring whether type1 diabetes will emerge and thus will allow a large scale study to answer this question.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Submicron-sized ultrasound contrast agents as therapeutic peptide delivery vehicles in type 1 diabetes.
   Ciccaglione M, Abenojar E, Kosmides T, DiLisio JE, et al · · 2026 · PMID 42244978 · DOI 10.7150/thno.126925