A Study of the Continuous Glucose Monitoring System for Home Use in Patients With Diabetes
NCT ID: NCT04964752
Last Updated: 2021-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
144 participants
INTERVENTIONAL
2021-07-30
2022-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System
NCT07092761
Glucose Differences Between the Left Arm and Right Arm in Diabetic Patients Using a Continuous Glucose Monitor
NCT04790760
Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
NCT01514292
CGM Use in COVID19 Patients (Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2))
NCT04756141
Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus
NCT04653454
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
the upper arm group on Day 2
The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2.
continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
the upper arm group on Day 15±1 day
The upper arm group to perform Visit 3 venous blood glucose measurement on Day 15±1 day.
continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
the upper arm group on Day 29±1 day
The upper arm group to perform Visit 3 venous blood glucose measurement on Day 29±1 day.
continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
the abdomen group on Day 2
The abdomen group to perform Visit 3 venous blood glucose measurement on Day 2.
continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
the abdomen group on Day 15±1
The abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1.
continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
the abdomen group on Day 29±1
The abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1.
continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female age ≥ 18 years old and ≤ 70 years old
3. Willingness to adopt measures to prevent water coming into contact with the device sensor (e.g. abstain from swimming, sauna, avoid hitting the sensor with direct jets of water)
4. Ability to communicate with the investigators, able to operate medical device after training and comply with the testing procedures outlined in this protocol (including, but not limited to, willing to wear the continuous glucose monitor and testing capillary blood glucose)
5. Subjects who show understanding of the study procedures and willing to sign a written informed consent form.
Exclusion Criteria
2. HbA1c \>13% or urine ketone 3+
3. Use of pacemaker
4. Body Mass Index (BMI) ≤18.0kg/m2
5. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites, i.e. upper arm or abdomen (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
6. Any psychiatric disease such as depression or anxiety
7. Any severe hepatic, renal, cardiac, cerebral, respiratory or neurological diseases (e.g. serum ALT, AST, Creatinine level ≥3 times the upper limit of normal)
8. Has a MRI scan, CT scan or other procedure requiring the subject be under strong magnetic or electromagnetic environment, scheduled during the proposed study participation
9. Blood loss \>400ml in the past 3 months (including blood donation)
10. Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study
11. Difficulty in sampling venous blood or cannot tolerate venipuncture
12. Participated in other investigational studies in the past 3 months
13. Currently pregnant or lactating women, or positive pregnancy test
14. Any condition that, in the opinion of the investigator, renders the subject not suitable for the study.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Powder (Guangzhou) Pharmaceuticals Limited
UNKNOWN
Powder Pharmaceuticals (HK) Co., Ltd
UNKNOWN
Lee's Pharmaceutical Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elaine Chow, Prof.
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital, the Chinese University of Hong Kong
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PL-CGM-202006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.