Clinical trial NCT02283411: Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems
Official title: Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring System - Professional Sensors will be worn by adult subjects over a 14-day wear period.

The primary objective is to characterize the Systems performance with respect to Yellow Spring Instrument (YSI) reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in reference to YSI.

Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

240 subjects will be enrolled and additional healthy subjects may also be enrolled in the study as training subjects.

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 visits are scheduled during the 14-day sensor wear period. During each in-clinic visit, study staff performed IV blood draws to obtain venous blood for YSI reference glucose measurements.

Eligibility criteria: Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
3. 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)
4. 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.
5. 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.
6. Willing to perform a minimum of 8 finger sticks per day during the study.
7. Subject must be able to read and understand English.
8. 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.
9. Subject must be available to participate in all study visits.
10. Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
2. 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).
3. 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.
4. Subject is on dialysis.
5. 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.
6. Subjects with a history of hypoglycemia unawareness, hypoglycemic seizures or unconsciousness.
7. Subjects who have experienced diabetes-related complications requiring assistance from another person in the last six months.
8. Subject currently is participating in another clinical trial.
9. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
10. Subject is anemic.
11. Subject does not have a known insulin to carbohydrate ratio at the time of enrollment (IIT subjects only).
12. 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
13. 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.
14. Subject has an abnormal EKG, unless cleared for study participation by a cardiologist.
15. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

    Additional Criteria
16. 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.

Primary outcomes:
measure: The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI).
timeFrame: 14 days
measure: Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants.
timeFrame: Safety was evaluated throughout the subject's study participation.
Secondary outcomes:
measure: The Trend Accuracy of the System P Device Performance Was Evaluated.
timeFrame: 14 days
measure: The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated.
timeFrame: 14 days
measure: The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG).
timeFrame: 14 days
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: William Sansum Diabetes Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes & Osteoporosis Center
state: Idaho
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Atlanta Diabetes Associates
name: Bruce Bode, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainier Clinical Research Center
name: Ronald Brazg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sansum Diabetes Research Institute
name: Kristin Castorino, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Diablo Clinical Research
name: Mark Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Trials of Texas
name: Douglas Denham, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Rocky Mountain Diabetes & Osteoporosis Center
name: David Liljenquist, MD
role: PRINCIPAL_INVESTIGATOR
References: