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

Study Overview
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Brief Summary
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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。

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: continuous glucose-monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: the upper arm group on Day 2<br>The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2. | Device: continuous glucose-monitoring<br>* Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.<br>* Other names: CGM;|
| Other: the upper arm group on Day 15±1 day<br>The upper arm group to perform Visit 3 venous blood glucose measurement on Day 15±1 day. | Device: continuous glucose-monitoring<br>* Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.<br>* Other names: CGM;|
| Other: the upper arm group on Day 29±1 day<br>The upper arm group to perform Visit 3 venous blood glucose measurement on Day 29±1 day. | Device: continuous glucose-monitoring<br>* Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.<br>* Other names: CGM;|
| Other: the abdomen group on Day 2<br>The abdomen group to perform Visit 3 venous blood glucose measurement on Day 2. | Device: continuous glucose-monitoring<br>* Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.<br>* Other names: CGM;|
| Other: the abdomen group on Day 15±1<br>The abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1. | Device: continuous glucose-monitoring<br>* Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.<br>* Other names: CGM;|
| Other: the abdomen group on Day 29±1<br>The abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1. | Device: continuous glucose-monitoring<br>* Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.<br>* Other names: CGM;|

What is the study measuring?
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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 |