Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Abbott Sensor Based Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetes Mellitus, Type 1 and Type 2<br>Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes. | Device: Abbott Sensor Based Glucose Monitoring System<br>* Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL. | 14 days | 
| Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants. | Safety of the Abbott Sensor Based Glucose Monitoring Systems, including adverse device effects and serious adverse device effects were assessed for all participants enrolled in the study. | Safety was evaluated throughout the subject's study participation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Trend Accuracy of the System P Device Performance Was Evaluated. | Trend accuracy of the device performance was assessed by comparing of the glucose rate of change results between the sensor glucose readings and YSI reference results for System P only. | 14 days | 
| The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated. | The Continuous Glucose Error Grid Analysis (CG-EGA) in the Hypoglycemic range (YSI ≤ 70 mg/dL), in the Euglycemic range (70 < YSI ≤ 180 mg/dL) and in the Hyperglycemic range (YSI > 180 mg/dL) were evaluated. | 14 days | 
| The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG). | Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the capillary blood glucose (BG) value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for capillary blood glucose (BG) levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had approximately112 capillary blood glucose (BG) samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the BG value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG levels <80 mg/dL. | 14 days |