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

Diabetes Clinical Trial

Official title:

Effectiveness and Safety Study of the Continuous Glucose Monitoring System for Home Use (Including In-clinic Sessions) in Patients With Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04964752
• Other study ID #: PL-CGM-202006
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2021
• Source: Lee's Pharmaceutical Limited
• Contact: Elaine Chow, Prof.
• Phone: (852) 3505 1642
• Email: e.chow[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: April 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited	Powder (Guangzhou) Pharmaceuticals Limited, Powder Pharmaceuticals (HK) Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%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
Primary	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
Primary	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
Primary	the percentage of MARD (Mean Absolute Relative Difference)	Analyze the proportion of readings in MARD <18% (95%CI<20%).	up to 29 days
Secondary	Alarm success rate1	Hypoglycemia alarm success rate and failure rate (sensitivity)	up to 29 days
Secondary	Alarm success rate2	Hypoglycemia detection rate and missed detection rate (specificity)	up to 29 days
Secondary	Alarm success rate 3	Hyperglycemia alarm success rate and failure rate	up to 29 days
Secondary	Alarm success rate 4	Hyperglycemia detection rate and missed detection rate	up to 29 days
Secondary	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