Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GK5 CGKM.
- Who it may be relevant to
- Registry conditions: Type1diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Device GK5 CGKM
Wear for a consecutive 15 days
Primary outcome measures
- System performance on glucose measurement [Time frame: 15 days]
- System performance on ketone measurement [Time frame: 15 days]
Secondary outcome measures (1)
- System-related Safety [Time frame: 15 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 2 centers
- The First Hospital of Hebei Medical University — Shijiazhuang
- Henan University of Science and Technology — Luoyang
Identifiers
NCT: NCT07139808 · SS-KY-CGM-0004