New Study Opportunities

Research Update

Go-Pen Study

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A new affordable insulin pen company is looking for feedback on a revolutionary design of what they called a Go-Pen.  The study is being done to see if the Go-Pen is easy to use and the company is looking for volunteers from January 11th – 18th. This short study is being conducted as a step in the process for FDA approval and will take about 90 minutes and will include one visit to the East Los Angeles study office.

 

The Go-Pen is designed as an easy way to give insulin that could be sold without a prescription and can be filled with any brand of insulin currently used, but you do not have to have diabetes to be part of the study.

 

You may be able to join the Go-Pen study if you:

• Are 18 years old or older

• Able to speak and read English or Spanish

• Have used an injection pen to give yourself medicine or a vial and syringe

• Be willing to complete study procedures

 

Participation in the study will last about 90 minutes. It will include one visit to the study office.

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Study procedures include:

• Reading the Go-Pen instructions

• Filling the Go-Pen with water

• Dialing a dose amount and splitting a dose

• Injecting the water into a sponge

• Answering questions about using the pen

You will be compensated for your time.

 

To learn more about the Go-Pen study and enroll, contact: Martha Walker or Sara Dokhan at 323-980-8446

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CGM Access

 

Continuous glucose monitoring (CGM) is a tool that improves health outcomes for people with type 1 and type 2 diabetes. However, there are disparities in access to CGM devices. Two of the biggest barriers in in providing CGMs are the time-consuming prior authorization process and the volume of documentation required from durable medical equipment distributors.

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On January 1, 2022, Medi-Cal began covering CGM for all patients with type 1 diabetes. This was good and bad news, because the implementation system through a centralized state system crashed because it was overwhelmed by demand. To fix this problem, Medi-Cal removed all prior authorization requirements for CGM devices. They also chose three pharmacies that would accept CGM prescriptions, and these pharmacies would mail the devices directly to patients. This policy solution has dramatically improved CGM access for both Libre and Dexcom users. As a result of broader CGM access, patients are also choosing to go on insulin pumps, particularly the Tandem Hybrid Closed Loop System, in record numbers.

 

This was good and bad news, because the implementation system through a centralized state system crashed because it was overwhelmed by demand. To fix this problem, Medi-Cal removed all prior authorization requirements for CGM devices. They also chose three pharmacies that would accept CGM prescriptions, and these pharmacies would mail the devices directly to patients. This policy solution has dramatically improved CGM access for both Libre and Dexcom users. As a result of broader CGM access, patients are also choosing to go on insulin pumps, particularly the Tandem Hybrid Closed Loop System, in record numbers.

 

Unfortunately, Medi-Cal may re-implement prior authorization for CGM devices. If this happens there could be a return of barriers to CGM device access. Our East Los Angeles staff is conducting a research project funded by the Helmsley Charitable Trust to review the impact of the Medi-Cal waiver that allowed access to CGMs. This project will provide valuable data to share with Medi-Cal and the diabetes community in hopes to retain the policy of no prior authorizations for people with diabetes served by Medi-Cal.