THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT. GLOSSARY OF TECHNICAL TERMS
This glossary contains explanations of certain technical terms used in this Document in connection with our Company and its business. Such terminology and meanings may not correspond to standard industry meanings or usages of those terms.
“acetaminophen” a non-opioid analgesic and antipyretic agent used to treat pain and fever
“artificial pancreas” an integrated diabetes management system that tracks blood glucose levels using a continuous glucose monitor and automatically delivers the insulin when needed using an insulin pump according to its control algorithm
“ascorbic acid” a potent reducing and antioxidant agent that functions in fighting bacterial infections, in detoxifying reactions, and in the formation of collagen in fibrous tissue, teeth, bones, connective tissue, skin, and capillaries
“basal insulin” a small, continuous infusion of background insulin delivered automatically at a programmed rate, all day and night
“BG Port” blood glucose strip port, the port that accepts and electrically connects a disposable blood glucose strip to the electronics
“BGMS” blood glucose monitoring system
“BLE” bluetooth low energy
“blood glucose” blood glucose, also referred to as blood sugar, is the amount of glucose in your blood, an indicator of diabetes monitoring
“bolus insulin” insulin that is taken to lower abnormally high blood glucose levels, typically used to control blood glucose levels following a meal or to counteract an unpredicted high blood glucose level
“calibration-free” also known as “factory-calibrated”, the ability to use the sensor without the need for BGMS calibration; while users may opt to calibrate at his/her own discretion, a calibration-free CGMS does not require the user to perform a finger stick blood glucose calibration before displaying the glucose values
–32– THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT. GLOSSARY OF TECHNICAL TERMS
“cannula” tiny plastic tube that is usually placed under the skin for insulin delivery
“CE marking” a certification marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area
“CGMS” continuous glucose monitoring system
“cloud” the computers and connections that support cloud computing
“CRO” contract research organization, a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis
“CSII therapy” continuous subcutaneous insulin infusion therapy
“diabetes” a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces
“diabetes management diabetes treatment and monitoring devices medical devices”
“EU5” the United Kingdom, Germany, France, Italy and Spain
“FAS” full analysis set
“GCP” good clinical practice, an international ethical and scientific quality standard for the performance of a clinical trial on medicinal products involving humans
“gestational diabetes” a type of diabetes that consists of high blood glucose during pregnancy and is associated with complications for both the mother and child
“glucose sensor electrode” the particular electrode located on the continuous glucose monitoring sensor that is used to measure the presence of glucose in the interstitial fluid
“glycemic” pertaining to or suffering from glycemia (i.e., level of sugar (glucose) in the blood)
–33– THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT. GLOSSARY OF TECHNICAL TERMS
“GMP” good manufacturing practices, the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification
“HbA1C” hemoglobin A1C, one of the indicators in the monitoring and management of diabetes
“hematocrit” or “HCT” a blood test that measures how much of a person’s blood is made up of red blood cells
“hs CRP+CRP” high-sensitivity C-reactive protein test, also known as full-range CRP test; regular CRP test measures general levels of inflammation in your body, while high sensitivity CRP test detects presences of low levels blood CRP which is usually associated with certain heart conditions
“hypo/hyper-glycaemia”, incidence of high/low blood glucose levels “hyperglycemia” or “hypoglycemia”
“IDF” the International Diabetes Federation
“insulin” a hormone made by the pancreas that helps cells in the body take up glucose (sugar) from the blood to use for energy, which lowers blood glucose levels
“insulin reservoir” insulin container on the insulin pump and tiny internal tube, which is inserted under the skin that comprises the insulin path from storage to human body
“interstitial proteins” proteins found within the interstitial fluid
“IVD” in vitro diagnostic medical devices
“ketone” a substance with the carbonyl group linking two carbon atoms
“KOL” key opinion leaders
“LCD” liquid-crystal display, a flat-panel display or other electronically modulated optical device that uses the light-modulating properties of liquid crystals combined with polarizers
–34– THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT. GLOSSARY OF TECHNICAL TERMS
“LED” light-emitting diode, a semiconductor diode that emits light when conducting current and is used in electronic displays
“MARD” mean absolute relative difference
“MAU” one of the indicators in the monitoring and management of diabetes
“MCU” main control unit, usually a microcontroller or microprocessor
“MDD” manufacturing medical devices
“MDI” multiple daily injection
“Minimum step size” the minimum amount of insulin the pump can deliver; all bolus and basal infusions are multiples of the minimum step size
“MITTP” modified intent-to-treat population
“non-diabetic” not related to or affected with diabetes
“non-intensive diabetics” diabetes patients with no need of intensive diabetes therapy
“NUT” the threaded element at the end of the pump drive system (gearbox) that interfaces with and pushes the reservoir plunger, which causes infusion
“OCC” occlusion sensor, which is used to detect infusion blockages
“pancreas” an organ in the body that secretes several hormones, including insulin and glucagon, as well as digestive enzymes that help break down food
“PDA” portable diabetes assistant, which is used as a remote control to display data and send data
“pivotal trial” a randomized, controlled clinical trial of a product designed to demonstrate statistically significant clinical efficacy and safety in human patients (in conjunction with performance of a therapeutic procedure) for regulatory approval of such product
–35– THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT. GLOSSARY OF TECHNICAL TERMS
“PM Module” power management module, which manages battery charging, discharging and external direct current power
“POCT” point-of-care-testing
“PPP” per-protocol population
“PPS” per-protocol set
“RF” radio frequency circuit that enables the BLE communication
“SMO” site management organization, an organization that provides clinical trial related services to medical device companies having adequate infrastructure and staff to meet the requirements of the clinical trial protocol
“SS” safety set
“subcutaneous interstitial fluid” fluid found in the spaces around cells
“Type 1 diabetes” a type of diabetes that can develop at any age but occurs most frequently in children and adolescents. When one has Type 1 diabetes, his/her body produces very little or no insulin
“Type 2 diabetes” a type of diabetes more commonly found in adults and accounts for around 90% of all diabetes cases. When one has Type 2 diabetes, his/her body does not make good use of the insulin that it produces
“uric acid” a product of the metabolic breakdown of purine nucleotides, and it is a normal component of urine
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