Assessment of an Integrated Continuous Glucose Monitor and Insulin Injection Port in Type 2 Diabetes

Launched by PACIFIC DIABETES TECHNOLOGIES · Jan 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device that combines a continuous glucose monitor (CGM) with an insulin injection port for people with Type 2 diabetes. The goal is to see if this device can accurately monitor glucose levels for a week while also looking at how it affects insulin injections. Researchers want to find out how safe and convenient this device is compared to the standard method of multiple daily insulin injections, as well as how accurate the glucose readings are.

To participate in the trial, you need to be over 20 years old and have Type 2 diabetes for more than six months. You should also be able to see well and handle the devices easily. During the study, you'll wear two CGM devices and do some blood glucose tests for seven days. It's important to note that people with certain untreated health issues, like severe heart problems or infections, won't be eligible. This trial is currently not recruiting participants yet, but it aims to provide valuable information to improve diabetes management in the future.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Type 2 diabetes with duration \> 6 months and age over 20;
• • sufficient manual dexterity and visual acuity;
• • willingness to wear two CGM devices and perform BG tests for 7 days.
• Exclusion criteria:
• • untreated proliferative retinopathy;
• • untreated mental illness that precludes study adherence
• • untreated cardiovascular disorder such as unstable angina, severe heart failure,
• • infectious diseases such untreated hepatitis, HIV, or active Covid-19;
• • other severe body system disease.