DiabetesNCT04964752
A Study of the Continuous Glucose Monitoring System for Home Use in Patients With Diabetes
A study testing continuous glucose-monitoring in people with Diabetes, run by Lee's Pharmaceutical Limited.
Trial summary
Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- continuous glucose-monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or 2 diabetes mellitus
- Male or female age ≥ 18 years old and ≤ 70 years old
- 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)
- 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)
- Subjects who show understanding of the study procedures and willing to sign a written informed consent form.
Who cannot join
- Hospitalization due to diabetic ketoacidosis or severe hypoglycemia, within 3 months prior to screening
- HbA1c >13% or urine ketone 3+
- Use of pacemaker
- Body Mass Index (BMI) ≤18.0kg/m2
- 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)
- Any psychiatric disease such as depression or anxiety
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- Any severe hepatic, renal, cardiac, cerebral, respiratory or neurological diseases (e.g. serum ALT, AST, Creatinine level ≥3 times the upper limit of normal)
- 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
- Blood loss >400ml in the past 3 months (including blood donation)
- Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study
- Difficulty in sampling venous blood or cannot tolerate venipuncture
- Participated in other investigational studies in the past 3 months
- Currently pregnant or lactating women, or positive pregnancy test
- Any condition that, in the opinion of the investigator, renders the subject not suitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety Study of the Continuous Glucose Monitoring System for Home Use (Including In-clinic Sessions) in Patients With Diabetes
Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。
- Conditions
- Diabetes
- Being tested
- continuous glucose-monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose-monitoringDevice
Also called CGM
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
| Study group | Role | What they receive |
|---|---|---|
| the upper arm group on Day 2 | Other | The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2. Receives: Device: continuous glucose-monitoring |
| the upper arm group on Day 15±1 day | Other | The upper arm group to perform Visit 3 venous blood glucose measurement on Day 15±1 day. Receives: Device: continuous glucose-monitoring |
| the upper arm group on Day 29±1 day | Other | The upper arm group to perform Visit 3 venous blood glucose measurement on Day 29±1 day. Receives: Device: continuous glucose-monitoring |
| the abdomen group on Day 2 | Other | The abdomen group to perform Visit 3 venous blood glucose measurement on Day 2. Receives: Device: continuous glucose-monitoring |
| the abdomen group on Day 15±1 | Other | The abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1. Receives: Device: continuous glucose-monitoring |
| the abdomen group on Day 29±1 | Other | The abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1. Receives: Device: continuous glucose-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
%20/20 agreement between the test device readings and the EKF readings: %20/20 = A + B
A = the proportion of the CGM system values that were within ±20% of paired EKF values >4.4mmol/L (>80 mg/dL) B = the proportion of the CGM system values that were within ±1.1mmol/L (20mg/dL) of paired EKF values ≤4.4mmol/L (≤80mg/dL)
Measured: up to 29 days
Proportion of readings in Region A + Region B of Clarke Error Grid
Analyze the proportion of readings in each region (Region A, B, C D and E). Readings in Region A are clinically accurate, while readings in Region B are of clinically acceptable accuracy. Readings in C, D and E are inaccurate to various degrees.
Measured: up to 29 days
Proportion of readings in Region A + Region B of Consensus Error Grid
Analyze the proportion of readings in Region A and Region B.
Measured: up to 29 days
the percentage of MARD (Mean Absolute Relative Difference)
Analyze the proportion of readings in MARD <18% (95%CI<20%).
Measured: up to 29 days
Secondary outcomes (5)
Alarm success rate1
Hypoglycemia alarm success rate and failure rate (sensitivity)
Measured: up to 29 days
Alarm success rate2
Hypoglycemia detection rate and missed detection rate (specificity)
Measured: up to 29 days
Alarm success rate 3
Hyperglycemia alarm success rate and failure rate
Measured: up to 29 days
Alarm success rate 4
Hyperglycemia detection rate and missed detection rate
Measured: up to 29 days
Sensor Stability
Compare the accuracy of the sensor between Day 2(22h~48h after insertion), Day 15±1day, Day 29±1day to evaluate sensor.
Measured: up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Powder (Guangzhou) Pharmaceuticals Limited, Powder Pharmaceuticals (HK) Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Elaine Chow, Prof., Principal investigator, Prince of Wales Hospital, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964752
- Sponsor's protocol ID
- PL-CGM-202006
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Study of the Continuous Glucose Monitoring System for Home Use (Including In-clinic Sessions) in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT04964752
- Acronym / sponsor ID
- PL-CGM-202006
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Powder (Guangzhou) Pharmaceuticals Limited, Powder Pharmaceuticals (HK) Co., Ltd
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| the upper arm group on Day 2 | Other | Device: continuous glucose-monitoringThe upper arm group to perform Visit 3 venous blood glucose measurement on Day 2. |
| the upper arm group on Day 15±1 day | Other | Device: continuous glucose-monitoringThe upper arm group to perform Visit 3 venous blood glucose measurement on Day 15±1 day. |
| the upper arm group on Day 29±1 day | Other | Device: continuous glucose-monitoringThe upper arm group to perform Visit 3 venous blood glucose measurement on Day 29±1 day. |
| the abdomen group on Day 2 | Other | Device: continuous glucose-monitoringThe abdomen group to perform Visit 3 venous blood glucose measurement on Day 2. |
| the abdomen group on Day 15±1 | Other | Device: continuous glucose-monitoringThe abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1. |
| the abdomen group on Day 29±1 | Other | Device: continuous glucose-monitoringThe abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 or 2 diabetes mellitus
- Male or female age ≥ 18 years old and ≤ 70 years old
- 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)
- 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)
- Subjects who show understanding of the study procedures and willing to sign a written informed consent form.
Key exclusion criteria (14 listed)
- Hospitalization due to diabetic ketoacidosis or severe hypoglycemia, within 3 months prior to screening
- HbA1c >13% or urine ketone 3+
- Use of pacemaker
- Body Mass Index (BMI) ≤18.0kg/m2
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous glucose-monitoringAlso: CGMContinuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. | Device | the abdomen group on Day 15±1, the abdomen group on Day 2, the abdomen group on Day 29±1, the upper arm group on Day 15±1 day, the upper arm group on Day 2, the upper arm group on Day 29±1 day |
Primary outcome
%20/20 agreement between the test device readings and the EKF readings: %20/20 = A + B
Time frame: up to 29 days
A = the proportion of the CGM system values that were within ±20% of paired EKF values >4.4mmol/L (>80 mg/dL) B = the proportion of the CGM system values that were within ±1.1mmol/L (20mg/dL) of paired EKF values ≤4.4mmol/L (≤80mg/dL)
Proportion of readings in Region A + Region B of Clarke Error Grid
Time frame: up to 29 days
Analyze the proportion of readings in each region (Region A, B, C D and E). Readings in Region A are clinically accurate, while readings in Region B are of clinically acceptable accuracy. Readings in C, D and E are inaccurate to various degrees.
Proportion of readings in Region A + Region B of Consensus Error Grid
Time frame: up to 29 days
Analyze the proportion of readings in Region A and Region B.
the percentage of MARD (Mean Absolute Relative Difference)
Time frame: up to 29 days
Analyze the proportion of readings in MARD <18% (95%CI<20%).
5 secondary outcomes
Alarm success rate1
Time frame: up to 29 days
Alarm success rate2
Time frame: up to 29 days
Alarm success rate 3
Time frame: up to 29 days
Alarm success rate 4
Time frame: up to 29 days
Sensor Stability
Time frame: up to 29 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Chow, Prof. principal investigator
Prince of Wales Hospital, the Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing continuous glucose-monitoring in people with Diabetes, run by Lee's Pharmaceutical Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine Chow, Prof. ((852) 3505 1642, e.chow@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%20/20 agreement between the test device readings and the EKF readings: %20/20 = A + B (time frame: up to 29 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.