A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces
Completed · Phase 1
Conditions studied: Diabetes
In brief
The purpose of this study is to compare two continuous glucose sensors, one placed subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.
Key facts
- Study ID
- NCT01093833
- Run by
- Becton, Dickinson and Company
- People needed
- 40
- Starts
- 2009-01-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2016-05-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Otherwise healthy male and female subjects with Type 1 or Type 2 diabetes mellitus
- Signed informed consent
- Age between 18 and 65 years, inclusive
- Body mass index between 19 and 30 kg/m², inclusive
- HbA1c < 11 %
You may not qualify if…
- Uncontrolled arterial hypertension (diastolic blood pressure >90 mm Hg and/or systolic blood pressure >160 mm Hg)
- Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit
- Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal.
- Severe acute diseases, i.e. cardiac, pulmonary, gastrointestinal, hepatic, neurologic, or infectious that might interfere with the performance of this study, as judged by the Investigator.
- Severe chronic diseases, as judged by the investigator other than Type 1 Diabetes
- Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- Known microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as e.g. history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment
- Positive serology for Hepatitis B, Hepatitis C or HIV
- Pregnancy, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
- Known current or recent alcohol or drug abuse
- Blood donation of more than 500 ml within the last three months
- Anticoagulant therapy
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Previous participation in a study involving the GBP-based sensor
- Has taken more than 4000 mg or more of acetaminophen within the past 24 hours (i.e. 13 or more regular strength or 8 or more extra strength Tylenol in the past 24 hours)
- Any skin condition that may be judged to have affect on study ( e.g., bad sunburn, pre-existing dermatitis)
Where it is running
- Profil Institute for Clinical Research Inc — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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