A Study of the Continuous Glucose Monitoring System for Home Use in Patients With Diabetes

July 11, 2021 updated by: Lee's Pharmaceutical Limited

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。

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 1 or 2 diabetes mellitus
  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:

  1. Hospitalization due to diabetic ketoacidosis or severe hypoglycemia, within 3 months prior to screening
  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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: the upper arm group on Day 2
The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2.
Device: continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Other Names:
  • CGM
Other: 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.
Device: continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Other Names:
  • CGM
Other: 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.
Device: continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Other Names:
  • CGM
Other: the abdomen group on Day 2
The abdomen group to perform Visit 3 venous blood glucose measurement on Day 2.
Device: continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Other Names:
  • CGM
Other: the abdomen group on Day 15±1
The abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1.
Device: continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Other Names:
  • CGM
Other: the abdomen group on Day 29±1
The abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1.
Device: continuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Other Names:
  • CGM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
%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)
up to 29 days
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.
up to 29 days
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.
up to 29 days
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%).
up to 29 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alarm success rate1
Time Frame: up to 29 days
Hypoglycemia alarm success rate and failure rate (sensitivity)
up to 29 days
Alarm success rate2
Time Frame: up to 29 days
Hypoglycemia detection rate and missed detection rate (specificity)
up to 29 days
Alarm success rate 3
Time Frame: up to 29 days
Hyperglycemia alarm success rate and failure rate
up to 29 days
Alarm success rate 4
Time Frame: up to 29 days
Hyperglycemia detection rate and missed detection rate
up to 29 days
Sensor Stability
Time Frame: up to 29 days
Compare the accuracy of the sensor between Day 2(22h~48h after insertion), Day 15±1day, Day 29±1day to evaluate sensor.
up to 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lee's Pharmaceutical Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Powder (Guangzhou) Pharmaceuticals Limited
Powder Pharmaceuticals (HK) Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elaine Chow, Prof., Prince of Wales Hospital, the Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PL-CGM-202006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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