Recruiting

Continuous Glucose and Ketone Monitoring for Adults with Type 1 Diabetes

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What is being tested

GK5 CGKM

Device
Who is being recruted

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorHenan University of Science and Technology
Study ContactPeng Liu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on testing a new continuous glucose and ketone monitoring system designed for adults with type 1 diabetes. The goal is to check how accurately and safely this system can measure glucose and ketone levels compared to standard laboratory methods. The study aims to provide a more convenient way for individuals to monitor their glucose and ketone levels in real-time, potentially improving diabetes management and reducing the burden of daily monitoring. Participants in the study will use the new monitoring system to collect data on their glucose and ketone levels. During the study, they will have three visits to the clinical site, during which blood samples will be taken to compare with the readings from the new system. This involves taking blood from a vein and checking these results against the sensor's readings. The study will evaluate if the new system delivers accurate and reliable results, helping to ensure it is both safe and effective for regular use.

Official TitleSafety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
NCT07139808
Principal SponsorHenan University of Science and Technology
Study ContactPeng Liu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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
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14 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Adult patients with T1DM

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Henan University of Science and Technology

Luoyang, ChinaOpen Henan University of Science and Technology in Google Maps
Recruiting
One Study Center