Omnipod 5 Automated Insulin Delivery System Vocabulary

Vocabulary and key concepts for the Omnipod 5 Automated Insulin Delivery System, covering operational modes, safety protocols, and clinical study definitions.

Omnipod 5 Automated Insulin Delivery System

A single-hormone insulin delivery system intended to deliver $U-100$ insulin subcutaneously for the management of type $1$ diabetes in persons aged $2$ and older.

Automated Mode

A system state where the Omnipod 5 System modulates insulin delivery every $5$ minutes using current and predicted sensor glucose values to maintain blood glucose at a target level.

Manual Mode

A system state that delivers insulin at set rates based on a user-defined Basal Programme or manually adjusted rates.

Pod

A tubeless device that delivers insulin to the body, receives commands from the Omnipod 5 App, and receives glucose values from the Sensor.

Omnipod 5 App

A software application installed on the provided Controller that sends commands to the Pod and displays glucose and insulin information.

Compatible Insulins

NovoLog®/NovoRapid®, Humalog®, Admelog®/Insulin lispro Sanofi®, Trurapi®/Insulin aspart Sanofi®, and Kirsty® $U-100$ insulin.

Automated: Limited

A state in Automated Mode when the Pod is not receiving sensor glucose values; it compares the Automated Adaptive Basal Rate with the Manual Basal Programme and uses whichever is lower.

SmartAdjust™ technology

Technology that predicts where glucose will be $60$ minutes into the future to automatically pause or increase insulin delivery.

Adaptive Basal Rate

A continuous baseline insulin rate that the system adjusts up or down every $5$ minutes; it is updated with every Pod change based on historical needs.

Line of sight

The practice of wearing the Pod and Sensor on the same side of the body so they can communicate wirelessly without the body blocking the signal.

SmartBolus Calculator

A feature used to calculate a suggested bolus dose based on current sensor values, trends, carbs entered, and Insulin on Board ($IOB$).

Activity Feature

A setting available in Automated Mode that sets the Target Glucose to $8.3\,mmol/L$ ($150\,mg/dL$) and reduces insulin delivery for events like exercise.

Hazard Alarm

A high-priority alarm indicating a serious problem (e.g., Pod error, empty Pod, or blockage) that has stopped insulin delivery and typically requires a Pod change.

Advisory Alarm

A lower-priority alarm indicating a situation that needs attention, such as Low Pod Insulin or the Pod nearing its expiration time.

Blockage (Occlusion)

An interruption in insulin delivery from the Pod, often detected by the system after $3$ to $5\,units$ of missed insulin.

Hypoglycaemia

A condition where blood glucose is below $3.9\,mmol/L$ ($70\,mg/dL$), characterized by symptoms like shakiness, fatigue, and hunger.

Hyperglycaemia

A condition where blood glucose is above $13.9\,mmol/L$ ($250\,mg/dL$), characterized by symptoms like thirst, frequent urination, and fatigue.

Diabetic Ketoacidosis (DKA)

A life-threatening complication of diabetes occurring when there is insufficient insulin, characterized by high blood glucose and positive ketones.

Insulin to Carb (IC) Ratio

A setting representing the number of grams of carbohydrates covered by $1\,unit$ of insulin.

Correction Factor

A setting representing how much $1\,unit$ of insulin is expected to lower blood glucose.

Target Glucose

The specific glucose level the system aims to achieve; it is the only setting that can be changed to impact automated insulin delivery.

Duration of Insulin Action

The length of time insulin remains active in the body, used by the system to calculate Insulin on Board ($IOB$).

Pod Priming

An automated series of safety checks and preparation steps the System performs once the Pod is filled with a minimum of $85\,units$ of insulin.

Urgent Low Glucose

An advisory alarm triggered when the sensor glucose value is $3.1\,mmol/L$ ($55\,mg/dL$) or below.

Ingress Protection Rating IP28

A specification for the Pod indicating it is waterproof to a depth of $7.6\,metres$ ($25\,feet$) for up to $60\,minutes$.