Type 1 or Type 2 Diabetes
Conditions
Brief summary
From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation \[SD\] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose & Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).
Interventions
None listed
Sponsors
Sinocare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years, male or female; 2. Clinically diagnosed with diabetes; 3. Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring; 4. Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).
Exclusion criteria
1. Disagree to wear the investigational device continuously according to the requirements of the trial; 2. Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial; 3. Plan to undergo magnetic resonance imaging (MRI) during the clinical trial; 4. With diffuse subcutaneous nodules at the wearing site of the investigational device; 5. Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening; 6. With mental disorders, lack of self-control and inability to express clearly; 7. Have participated in any other clinical trial within the past 1 month; 8. Where the investigator thinks not suitable for being enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall mean absolute relative difference (MARD) | 8 or 15 days |
Countries
China
Outcome results
None listed