Status:
COMPLETED
Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professi...
Detailed Description
Sensors are inserted into the back of the subject's upper arm for up to fourteen (14) days. The subjects are expected to perform capillary BG tests during the 14-day sensor wear. Three in clinic visit...
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
- Use one of the following for their diabetes management:
- intensive insulin therapy (insulin therapy through an insulin pump and/or multiple daily insulin injections) or
- non-intensive insulin therapy (Basal insulin, injectable non-insulin anti-diabetic agents such as a pramlintide or GLP-1 agonists, NPH insulin either alone or in combination with regular insulin or fast acting insulin analogue, or oral medication)
- Intensive-insulin using (IIT) subjects only - During one of the in-clinic sessions, subject is willing to have their blood glucose levels manipulated into high and low glucose levels. Insulin-to-carbohydrate ratio and insulin sensitivity formula must be documented prior to having blood glucose levels manipulated. NIT subjects will only be observed during each in-clinic session.
- For subjects that exercise routinely (at least 3 times per week), willing to exercise during at least one of the in-clinic sessions, if asked.
- Willing to perform a minimum of 8 finger sticks per day during the study.
- Subject must be able to read and understand English.
- In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- Subject must be available to participate in all study visits.
- Subject must be willing and able to provide written signed and dated informed consent.
Exclusion
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is pregnant, is attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to female subjects only).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
- Subject is on dialysis.
- Subject has a history of untreated hypothyroidism, adrenal gland failure or insufficiency, celiac disease, renal failure, cystic fibrosis, unstable coronary heart disease, or serious psychiatric disorders.
- Subjects with a history of hypoglycemia unawareness, hypoglycemic seizures or unconsciousness.
- Subjects who have experienced diabetes-related complications requiring assistance from another person in the last six months.
- Subject currently is participating in another clinical trial.
- Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
- Subject is anemic.
- Subject does not have a known insulin to carbohydrate ratio at the time of enrollment (IIT subjects only).
- 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 HIV, Hepatitis B or C
- 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.
- Subject has an abnormal EKG, unless cleared for study participation by a cardiologist.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator.
- Additional Criteria
- The following subjects may participate in the study but will be excluded from all glycemic and exercise challenges:
- Subject's taking medications known to mask symptoms or hypoglycemia, such as beta blockers;
- Subjects with any of the following: clinically significant history of cardiovascular or cerebrovascular disease, cardiac arrhythmia, neurological disorders such as seizures, CVA, or syncope, or hypokalemia.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT02283411
Start Date
November 1 2014
End Date
March 1 2015
Last Update
February 22 2018
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
William Sansum Diabetes Center
Santa Barbara, California, United States, 93105
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598
3
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
4
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404