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

Not Applicable

• Conditions: Diabetes
• Interventions: Device: continuous glucose-monitoring

• Registration Number: NCT04964752
• Lead Sponsor: Lee's Pharmaceutical Limited

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。

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Last Update Submitted: 2021-07-11
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16
• Study Start: 2021-07-30
• Primary Completion: 2022-02-28
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the upper arm group on Day 2	continuous glucose-monitoring	The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2.
the abdomen group on Day 2	continuous glucose-monitoring	The abdomen group to perform Visit 3 venous blood glucose measurement on Day 2.
the upper arm group on Day 29±1 day	continuous glucose-monitoring	The upper arm group to perform Visit 3 venous blood glucose measurement on Day 29±1 day.
the abdomen group on Day 15±1	continuous glucose-monitoring	The abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1.
the upper arm group on Day 15±1 day	continuous glucose-monitoring	The upper arm group to perform Visit 3 venous blood glucose measurement on Day 15±1 day.
the abdomen group on Day 29±1	continuous glucose-monitoring	The abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1.

Primary Outcome Measures

Name	Time	Method
the percentage of MARD (Mean Absolute Relative Difference)	up to 29 days	Analyze the proportion of readings in MARD \<18% (95%CI\<20%).
%20/20 agreement between the test device readings and the EKF readings: %20/20 = A + B	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	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	up to 29 days	Analyze the proportion of readings in Region A and Region B.

Secondary Outcome Measures

Name	Time	Method
Alarm success rate 4	up to 29 days	Hyperglycemia detection rate and missed detection rate
Alarm success rate 3	up to 29 days	Hyperglycemia alarm success rate and failure rate
Alarm success rate2	up to 29 days	Hypoglycemia detection rate and missed detection rate (specificity)
Alarm success rate1	up to 29 days	Hypoglycemia alarm success rate and failure rate (sensitivity)
Sensor Stability	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.