Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System

Launched by HENAN UNIVERSITY OF SCIENCE AND TECHNOLOGY · Aug 21, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new device that continuously monitors both blood sugar (glucose) and ketone levels in adults with type 1 diabetes. The goal is to see if this device is accurate and safe to use by comparing its readings to standard laboratory blood tests. This could help people with type 1 diabetes better manage their condition by providing real-time information about their blood sugar and ketone levels.

Adults aged 18 and older who have type 1 diabetes and use an insulin pump are eligible to join, as long as they can have blood drawn from their arm and can follow the study instructions on their own. Participants will wear the new monitoring device and have regular blood tests for comparison. People with recent severe low blood sugar, recent diabetic ketoacidosis (a serious complication), certain heart or skin conditions, or who are pregnant are not eligible. If you qualify and decide to join, you will be asked to give informed consent, and the study team will guide you through what to expect during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)
• • Venous blood sampling access can be established in the forearm
• • Capable of independently reading instructions and complying with the clinical trial requirements
• • Willing to sign the Informed Consent Form (ICF)
• Exclusion Criteria:
• • Severe hypoglycemia within the past 6 months
• • A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months
• • Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
• • Severe skin conditions at the sensor wear site
• • Extensive systemic skin disorders
• • Having difficulty with wound healing, bleeding disorders, and/or taking anticoagulant medications
• • Anemia or abnormal hematocrit
• • Blood donation within the past 6 months
• • Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days
• • Current or recent (≤1 month) participation in other clinical trials
• • Planned MRI/CT scans during sensor wear
• • Allergy to medical adhesives or alcohol
• • Conditions impairing comprehension of informed consent or study procedures
• • Other exclusionary conditions per investigator's discretion