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

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: Not yet recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: continuous glucose-monitoring

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elaine Chow, Prof.; Phone Number: (852) 3505 1642; Email: e.chow@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
%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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alarm success rate1	Hypoglycemia alarm success rate and failure rate (sensitivity)	up to 29 days
Alarm success rate2	Hypoglycemia detection rate and missed detection rate (specificity)	up to 29 days
Alarm success rate 3	Hyperglycemia alarm success rate and failure rate	up to 29 days
Alarm success rate 4	Hyperglycemia detection rate and missed detection rate	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.	up to 29 days

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Collaborators: Powder (Guangzhou) Pharmaceuticals Limited; Powder Pharmaceuticals (HK) Co., Ltd
• Investigators: Principal Investigator: Elaine Chow, Prof., Prince of Wales Hospital, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID 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