Diabetes
Conditions
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。
Interventions
DEVICEcontinuous glucose-monitoring
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
Sponsors
Powder (Guangzhou) Pharmaceuticals Limited
Powder Pharmaceuticals (HK) Co., Ltd
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| %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. |
| the percentage of MARD (Mean Absolute Relative Difference) | up to 29 days | Analyze the proportion of readings in MARD \<18% (95%CI\<20%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Alarm success rate2 | up to 29 days | Hypoglycemia detection rate and missed detection rate (specificity) |
| Alarm success rate 3 | up to 29 days | Hyperglycemia alarm success rate and failure rate |
| Alarm success rate 4 | up to 29 days | Hyperglycemia detection rate and missed detection rate |
Contacts
Primary ContactElaine Chow, Prof.
Outcome results
None listed