30 Participants Needed

Ultrasound for Type 2 Diabetes

(U/S_in_T2DM Trial)

JM
AH
Overseen ByAlice Hahn
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Oral anti-diabetic drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires participants to be on a stable treatment regimen of certain oral anti-diabetic drugs like Metformin, Sulfonylureas, Meglitinides, or Thiazolidinediones. Other medications that interfere with glucose or insulin metabolism are prohibited, so you may need to stop those.

What data supports the effectiveness of the treatment Ultrasound Delivery for Type 2 Diabetes?

There is no direct evidence from the provided research articles supporting the effectiveness of ultrasound delivery for treating Type 2 Diabetes. However, ultrasound is used in managing gestational diabetes by guiding treatment based on fetal growth, which suggests it can play a role in diabetes management.12345

Is ultrasound treatment generally safe for humans?

Research on ultrasound treatments, including for diabetes, shows it is generally safe. Studies in animals and some human procedures have not shown significant tissue damage, indicating good safety for potential clinical use.678910

How does ultrasound treatment for Type 2 Diabetes differ from other treatments?

Ultrasound treatment for Type 2 Diabetes is unique because it uses sound waves to potentially improve clinical assessments and management of diabetes-related conditions, unlike traditional treatments that often involve medication or lifestyle changes. This approach is novel as it may help in detecting cardiovascular risks and other complications more sensitively than standard clinical examinations.1112131415

What is the purpose of this trial?

This is an open label, exploratory pilot study that will assess the effects of dual site focused pulsed ultrasound treatment on glycemic parameters in subjects with T2DM.

Research Team

RH

Raimund Herzog, MD

Principal Investigator

Yale University

Eligibility Criteria

Adults aged 21-75 with Type 2 Diabetes, BMI of 18 to ≤40 kg/m2, stable on certain oral diabetes meds (like Metformin), and not on insulin or other excluded drugs. They should have an HbA1c level between >7% and <10%, be generally healthy, and women must not be pregnant. Excluded are those with heart disease, severe hypoglycemia history, recent major surgery or infections like COVID-19.

Inclusion Criteria

I am taking diabetes medication like Metformin or similar.
I am not pregnant or breastfeeding and have a negative pregnancy test.
HbA1c > 7.0% and < 10% by local laboratory analysis
See 5 more

Exclusion Criteria

Any nerve stimulation study or implanted stimulator
Participation in an investigational study within 30 days prior to dosing
History of recent traumatic injury
See 24 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dual site focused pulsed ultrasound treatment on the liver and intestinal target sites

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Ultrasound Delivery
Trial Overview The trial is testing the impact of focused pulsed ultrasound treatment at two body sites on blood sugar control in people with Type 2 Diabetes Mellitus (T2DM). It's an open label study where all participants know they're receiving the ultrasound treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 60 minute, dual site stimulationExperimental Treatment1 Intervention
Ultrasound Delivery for 60 minutes total: 30 minutes on the liver target site and 30 minutes on the intestinal target site.
Group II: 30 minute, dual site stimulationExperimental Treatment1 Intervention
Ultrasound Deliveryfor 30 minutes total: 15 minutes on the liver target site and 15 minutes on the intestinal target site.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

GE Healthcare

Industry Sponsor

Trials
307
Recruited
634,000+
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Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

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Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Findings from Research

Ultrasound scanning can effectively identify and characterize subcutaneous lipohypertrophy in patients with type 1 diabetes, revealing different tissue types that affect insulin absorption.
In a study of 20 patients, avoiding insulin injections in ultrasound-identified lipohypertrophic areas led to a significant improvement in HbA1c levels after 3 months, highlighting the potential of ultrasound in enhancing glycemic control.
Ultrasound characterization of insulin induced lipohypertrophy in type 1 diabetes mellitus.Bertuzzi, F., Meneghini, E., Bruschi, E., et al.[2022]
In a study of 221 women with gestational diabetes mellitus (GDM), ultrasound-guided management led to significantly better neonatal outcomes, including fewer admissions to Special Care or Intensive Care Nursery (29.1% vs. 48.3%) and shorter hospital stays (3.7% vs. 13.8%).
Neonates managed with ultrasound guidance also experienced lower rates of hypoglycemia after birth (42.5% vs. 56.3%), indicating that tailoring GDM management based on fetal growth can enhance safety and health outcomes for newborns.
Fetal ultrasound scans to guide management of gestational diabetes: Improved neonatal outcomes in routine clinical practice.Davidson, SJ., de Jersey, SJ., Britten, FL., et al.[2021]
A flexible ultrasound-based management strategy for gestational diabetes (GDM) led to better pregnancy outcomes, including lower rates of large for gestational age (LGA) and macrosomia, compared to conventional management.
In the study of 229 women, the modified management group had a significantly lower incidence of LGA (7.9% vs 17.9%) and macrosomia (3.3% vs 11.5%), demonstrating that tailoring treatment based on fetal abdominal circumference measurements can optimize care for women with GDM.
Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial.Bonomo, M., Cetin, I., Pisoni, MP., et al.[2020]

References

Ultrasound characterization of insulin induced lipohypertrophy in type 1 diabetes mellitus. [2022]
Fetal ultrasound scans to guide management of gestational diabetes: Improved neonatal outcomes in routine clinical practice. [2021]
Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial. [2020]
Discrepancy in term calculation from second trimester ultrasound scan versus last menstrual period in women with type 1 diabetes. [2019]
Optimal Timing of Prenatal Ultrasound in Predicting Birth Weight in Diabetic Pregnancies. [2021]
Therapeutic Ultrasound-Induced Insulin Release in Vivo. [2021]
Ultrasound-Targeted Microbubble Destruction Mediates Gene Transfection for Beta-Cell Regeneration and Glucose Regulation. [2021]
Ultrasound-Guided Human Islet Transplantation: Safety, Feasibility, and Efficacy Analysis. [2023]
Modeling of Ultrasound Stimulation of Adolescent Pancreas for Insulin Release Therapy. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Transcutaneous Ultrasound-Mediated Nonviral Gene Delivery to the Liver in a Porcine Model. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of ultrasound diagnosis of fetal anomalies in women with pregestational diabetes: University of Florida experience. [2019]
Relationship between ultrasound findings in pregnancy and neonatal morbidity. [2019]
The fetus of a diabetic mother: sonographic evaluation. [2016]
Point-of-Care Ultrasound (POCUS) in the Field of Diabetology. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Estimators of birth weight in pregnant women requiring insulin: a comparison of seven sonographic models. [2016]
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