Type 1 diabetes, Type 2 diabetes
Conditions
Interventions
Single-arm:Guardian Sensor with the Guardian Connect System
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subject is 14 - 75 years of age at time of screening. 2. Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. 3. Subject has adequate venous access as assessed by investigator or appropriate staff. 4. Subject is willing to follow the study procedures and willing to come to study visits.
Exclusion criteria
Exclusion criteria: 1. Subject will not tolerate tape adhesive in the area of Guardian? Sensor (3) placement as assessed by qualified individual. 2. Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection). 3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks. 4. Subject is female and has a positive pregnancy screening test. 5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator. 6. Subject is female and plans to become pregnant during the course of the study. 7. Subject has a hematocrit (Hct) lower than the normal reference range. 8. Subject may not be on the research staff of those performing this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HCT;A1C;Pregnancy Urine;demographic andbaseline characteristics;fingerstick glucose;interstitial fluid glucose levels;blood plasma glucose; | — |
Countries
China
Contacts
Public ContactBo Jian
Outcome results
None listed