Diabetes Mellitus
Conditions
Interventions
Evaluation:Accuracy of Device
Sponsors
Abbott Diabetes Care
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subject must be at least 18 years of age. 2. Subject must have type 1 or type 2 diabetes prior to enrollment. 3. Subject must require insulin therapy through an insulin pump and/or single or multiple daily insulin injections which were first started at least 6 months prior to enrollment and will be ongoing during the study. 4. Subject must be able to read and understand Chinese. 5. In the investigator’s opinion, the Subject must be able to follow the instructions provided to him/her by study site and perform all study tasks as specified by the protocol. 6. Subject must be available to participate in all study visits. 7. Subject must be willing and able to provide written signed and dated informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only). 3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. 4. Subject currently is participating in another clinical trial. 5. Subject has donated blood in 3 months prior to the beginning of the study activities. 6. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to: ? History of Human Immunodeficiency Virus (HIV), Hepatitis B or C, or other blood-borne pathogen; ? History of abnormal hematocrit, platelet and hemoglobin within two months. ? History of anemia. 7. Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding (such as coagulation disorder). 8. Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends. 9. Subject is unsuitable for participation due to any other cause as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy using Consensus Error Grid; | — |
Countries
China
Contacts
Public ContactProfessor Linong Ji
Outcome results
None listed