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

NCT04964752 | Unknown

• 1 other identifier: PL-CGM-202006
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。

Conditions

Diabetes

Outcome Measures

Primary Outcomes (4)

• %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)

  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.

  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.

  up to 29 days

• the percentage of MARD (Mean Absolute Relative Difference)

  Analyze the proportion of readings in MARD \<18% (95%CI\<20%).

  up to 29 days

Secondary Outcomes (5)

• Alarm success rate1

  up to 29 days

• Alarm success rate2

  up to 29 days

• Alarm success rate 3

  up to 29 days

• Alarm success rate 4

  up to 29 days

• Sensor Stability

  up to 29 days

Study Arms (6)

the upper arm group on Day 2

OTHER

The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2.

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.

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.

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.

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.

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.

Device: continuous glucose-monitoring

Interventions

continuous glucose-monitoring DEVICE

Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.

Also known as: CGM

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• Powder (Guangzhou) Pharmaceuticals Limited: collaborator
• Powder Pharmaceuticals (HK) Co., Ltd: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Elaine Chow, Prof.

  Prince of Wales Hospital, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Chow, Prof.

CONTACT

(852) 3505 1642; e.chow@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 16, 2021
• Study Start: July 30, 2021
• Primary Completion: February 28, 2022
• Study Completion: April 30, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share