The ReCET Study is an investigational clinical device study currently being conducted at Robert Wood Johnson Medical School that seeks to test the safety and effectiveness of the ReCET procedure, a non-surgical treatment for adults with type 2 diabetes. The study is sponsored by Endogenex, which also designed the ReCET procedure in conjunction with the Mayo Clinic. This procedure aims to improve blood sugar levels in type 2 diabetes patients by endoscopically inserting a specialized catheter through the mouth into the duodenum. The catheter delivers a controlled electric charge to the duodenal mucosa, which can then lead to natural regeneration of mucosal cells and improved glycemic control. No part of the device is left in the duodenum and the patient can return home and resume normal activity on the same day following routine observation.



Christoph Buettner, MD-PhD, Professor of Medicine and Chief of the Division of Endocrinology, Metabolism, & Nutrition, is leading the ReCET study team at RWJMS– one of thirty-six sites across the U.S. and Australia – and has been actively enrolling patients since September 2024, with the first patient successfully enrolled and randomized in October. Currently two patients are enrolled in the study as of this newsletter publication. The team will follow all patients for one year following their procedures with monthly check-ups as well as free diabetes education and lifestyle counseling. 

Congratulations Dr. Buettner and Jonah!

Christoph Buetter and Jonah Lee (left to right)

Please shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu if you have a new study, grant award or publication from your area that you’d like to share with your fellow Rutgers Health study teams!

Members of the NJ ACTS GREAT (Genetically Informed Research, Education, and Treatment) core will present on Genetic Testing in Clinical Research.

Evan Brittain MD, MSc

Vanderbilt Heart

Dr. Brittain will describe the available Fitbit data streams in the All of Us Research Program and how the Fitbit data is curated for clinical research and discovery. Results of several recent projects leveraging the combination of Fitbit and EHR data will be discussed and how that data can inform future directions involving clinical trials.

The date on the current version of the 1572 is expired! Here's what to do until a new version is released:

For those unfamiliar with FDA-regulated drug research, Form FDA 1572, also known as the "Statement of Investigator," is a legally binding document required by the FDA for clinical investigators conducting trials of investigational drugs or biologics under an Investigational New Drug Application (IND), wherein the investigator agrees to follow FDA regulations and ensures ethical and scientific conduct of the trial.

Although the 1572 is an FDA form, the federal government’s Office of Management and Budget (OMB) is responsible for certifying that the 1572 meets the requirements of the Paperwork Reduction Act. It is that OMB certification that expires, so the form itself does not expire in the traditional sense. This means that the OMB expiration does not invalidate the form, but the FDA may release a newer version with an updated expiration date, and investigators/sponsors should always use the most current version. 

So, should a new form be prepared and signed when the OMB expiration date is reached? No, there is no need to prepare and sign a new 1572 when the OMB expiration date has been reached on an existing 1572. Likewise, if preparing a 1572 for a new study, check here to see if the FDA has released the new version, but if not, you may continue using the current version.

For more information, see this FDA Frequently Asked Questions guidance.

Are you writing a Rutgers Health Investigator-initiated protocol? Does your study entail consenting participants?

If so, your study requires review by the Rutgers Health Scientific Review Board (SRB) before you submit to the IRB.

The Rutgers Health SRB consists of a panel of investigators from across various scientific disciplines with expertise in clinical research. Your protocol will be reviewed to assure that the study design is sound and feasible. The goal is to assure successful implementation of your study.



For more information about the SRB, please visit our website. To submit your study for SRB review, click here.

You can find OnCore notes by clicking on the note icon in the top left corner of PC console. If no icon is present, a note has not been created yet. Alternatively, they can be found in Documents/Info -> Archive/Notes.

OnCore notes is updated in real time by the CTO team as progress is made in terms of calendar builds and budget/contract negotiations. All OnCore users should have access to notes.

Please shoot us an e-mail at clinicaltrials@rbhs.rutgers.edu with any questions about specific startup activities or access issues.

If you are using eReg for a study and you need to provide access to the files for a monitor, you can complete the request on our website. Please give us 3 business days prior to the monitoring visit. Note that if this is your monitor’s first time using the system, training (which takes about 25 minutes) is required.

The CTO recently launched a new portal to streamline common requests. This portal replaces our old DocuSign request process, and serves as a “one-stop shop” to request access to the various electronic systems we manage (i.e. OnCore, eReg, Advarra University, ClinCard, Deep6, DocuSign, etc.) and to request various services related to these systems (for example, OnCore reports, CAM requests and more.)  We hope this process will be less burdensome for our users and that it will allow us to more efficiently address your needs. Please check it out by clicking here and letting us know what you think!

Upcoming Training:

IS&T has begun rolling out the in-person training sessions for SlicerDicer on a monthly basis with seats limited to 18 per class. To register, kindly reach out to the three following contacts:



• Annette McCullough at chambeav@uhnj.org
• John Cummings at cumminjm@uhnj.org
• Sai Meegda at meegadasae@uhnj.org

The security behind SlicerDicer is high and specific. We will eventually require the IRB numbers and the names of the PIs whose projects you will need access to. Otherwise, SlicerDicer will not be able to generate data sets for you to use.

Rutgers and RWJBH have recently executed a Master Participation Agreement for non-oncology clinical research. The overarching purpose of this agreement is to promote research collaboration between the two entities as well as to appear as one to our external sponsors of research. 

Among many other things, this agreement establishes a more streamlined mechanism for RWJBH to participate as a site in Rutgers clinical trials by using a new template (a “covered study agreement”) which will generally eliminate the requirement for RWJBH to execute facility use agreements with sponsors.



Educational events related to the RU-RWJBH partnership are planned for the future. In the short term, however, please email Nancy Reilly reillyna@rbhs.rutgers.edu if you have any specific questions about what this agreement entails.

Clinical Research Pets of the Month

April's clinical research pets of the month are Ella, Junie, and Tintin! Their pet parent is Jonah Lee, research coordinator for RWJMS Endocrinology.

Tintin is a senior Westie at 15 years old and was rescued by Jonah's family in 2010. They affectionately refer to him as the grumpy old man and strangely his favorite treat is carrots, more so than chicken/beef or fancy dog treat.

Ella is Jonah's seven-year-old Great Pyrenees-Boxer mix who was rescued in Oklahoma in 2018. She spends about twenty hours a day sleeping and will always take your spot on the couch as soon as you get up.

Junie is Jonah's one year-old Great Pyrenees-Anatolian Shepherd mix who was rescued through a Texas human society last year. As opposed to Ella, she never sleeps and has ripped up every toy she has ever received within a day or wants to be outside and sniff everything. Recently she brought Jonah back a $10 bill on one of her outings, so it's been worth it. 

Congratulations to Jonah, Ella, Junie, and Tintin!

If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu

We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.