Type1diabetesNCT07139808
Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
A study testing GK5 CGKM in people with Type1diabetes, run by Henan University of Science and Technology at 2 sites in China.
Trial summary
The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- GK5 CGKM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Henan University of Science and Technology
Luoyang, Henan, 471003
Peng Liu, peng.liu87@outlook.com
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Huijuan Ma, MD, 0311-87155482
About this study
The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.
Read the detailed description
The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring (CGKM) system among adult patients with type 1 diabetes mellitus with respect to YSI and Randox reference venous plasma sample measurements. Up to 14 patients will be enrolled. Interstitial glucose and ketone readings from the sensors will be obtained immediatedly following each venous blood sample test. Each participant will make 3 visits to the clinical study site, including the screening visit.
- Conditions
- Type1diabetes
- Being tested
- GK5 CGKM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GK5 CGKMDevice
Wear for a consecutive 15 days
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with T1DM | Experimental | Adult patients with T1DM Receives: Device: GK5 CGKM |
What is being measured
The primary outcome is the main question the study is designed to answer.
System performance on glucose measurement
The CGK system performance for glucose measurement will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
Measured: 15 days
System performance on ketone measurement
The CGK system performance for ketone measurement will be assessed by comparing to the Randox comparator venous plasma measurements
Measured: 15 days
Secondary outcomes (1)
System-related Safety
Records of the adverse events and device-related incidence rates.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Liu, Henan University of Science and Technology
- Investigators
- Hongwei Jiang, Principal investigator, Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139808
- Sponsor's protocol ID
- SS-KY-CGM-0004
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No