AccuFine represents the next generation in blood glucose monitoring technology, designed for patients and healthcare providers who demand uncompromising accuracy and seamless integration into daily diabetes management. This advanced monitoring system utilizes a novel electrochemical sensor technology coupled with a sophisticated algorithm that minimizes common interferents, providing laboratory-grade results at the point of care. Engineered for both type 1 and type 2 diabetic populations, it supports intensive insulin therapy regimens and provides the data fidelity necessary for making critical therapeutic decisions. The system’s streamlined design reduces user steps, enhancing compliance, while its robust connectivity suite ensures data flows effortlessly into electronic health records and caregiver portals.

Features

• Third-generation biosensor technology with FAD-GDH enzyme for high specificity to glucose
• Extensive hematocrit range (10% to 65%) with automatic correction
• Requires a minimal 0.5 µL blood sample
• Test time of 4 seconds
• Operating range of 20 to 600 mg/dL (1.1 to 33.3 mmol/L)
• Bluetooth 5.0 connectivity for automatic syncing to companion app
• Memory capacity for 1,000 results with date and time stamps
• IP67 rating for dust and water resistance
• Compatible with AccuFine Diabetes Management Software for trend analysis and reporting

Benefits

• Achieves a mean absolute relative difference (MARD) of less than 5% across the entire glycemic range, providing confidence in every reading for safe insulin dosing.
• Reduces the frequency of painful fingersticks and conserves test strip supplies through highly accurate first-drop sampling.
• Empowers patients and clinicians with clear, actionable data patterns through automated glucose trend graphs and time-in-range metrics.
• Streamlines clinic workflows and remote patient monitoring through seamless, HIPAA-compliant data integration with major EHR platforms.
• Enhates long-term glycemic control by facilitating timely and precise adjustments to diet, activity, and medication.

Common use

AccuFine is primarily indicated for the quantitative measurement of glucose in fresh capillary whole blood samples from the fingertip or approved alternate sites (forearm, palm) from individuals with diabetes mellitus. It is used for self-monitoring of blood glucose (SMBG) to aid in the monitoring and prevention of hypoglycemia and hyperglycemia. The system is a critical tool for patients on multiple daily insulin injections or continuous subcutaneous insulin infusion (insulin pump) therapy, as well as for those managing type 2 diabetes with oral medications or lifestyle modifications. It is also utilized in clinical settings, including hospitals and physician offices, for rapid point-of-care testing.

Dosage and direction

Usage: AccuFine is a monitoring device, not a drug, and therefore does not have a “dosage.” Its use is directed by an individual’s diabetes management plan as prescribed by a healthcare professional.

Direction for Use:

1. Preparation: Wash and dry hands thoroughly with soap and warm water. Do not use alcohol-based cleansers as a primary method, as they can affect accuracy; if used, ensure the site is completely dry.
2. Loading Strip: Insert a new AccuFine test strip into the meter’s port. The meter will power on automatically.
3. Sampling: Prick a fingertip (or approved alternate site) with a sterile lancet. Gently massage the hand toward the finger to form a hanging drop of blood. Do not squeeze the finger excessively, as this can introduce interstitial fluid and skew results.
4. ⁠Application: Touch the tip of the test strip to the edge of the blood drop. The strip will draw the 0.5 µL sample into the chamber via capillary action.
5. ⁠Reading: Hold the meter steady. The result will be displayed on the screen in approximately 4 seconds, accompanied by an audible signal.
6. ⁠Disposal: Eject the used test strip into a sharps container. Properly dispose of the lancet.

Frequency of testing should be determined by a physician based on diabetes type, treatment regimen, and stability of glucose levels.

Precautions

• The meter and test strips are provided sterile and for single patient use only. Do not share the device or its components, as this poses a risk of bloodborne pathogen transmission.
• Use only AccuFine-branded test strips and control solutions. Using components from other systems will yield inaccurate and unreliable results.
• Store test strips in their original vial with the lid tightly closed. Do not expose strips to extreme temperatures, humidity, or direct sunlight. Do not use strips if the vial has been left open.
• Ensure the meter’s code (if applicable) matches the code on the test strip vial. The AccuFine Pro model features auto-coding.
• Factors including hypotension, severe dehydration, hypoxia, hyperlipidemia, and hyperuricemia may affect accuracy. Discuss specific concerns with a healthcare provider.
• Monitoring device performance with control solution is recommended with each new vial of strips, if the meter is dropped, or whenever results do not match clinical symptoms.

Contraindications

There are no absolute contraindications to measuring blood glucose. However, the use of the AccuFine system is not recommended in the following scenarios:

• For the diagnosis of diabetes mellitus. Diagnosis must be confirmed using laboratory methods on plasma samples.
• In critically ill patients, patients in shock, or those in hyperosmolar state with or without ketoacidosis, as results may not be reliable for guiding treatment.
• On sites that are visibly calloused, swollen, bruised, or infected.
• By individuals who are visually or physically impaired and cannot safely perform the lancing and testing procedure without assistance.

Possible side effect

As a monitoring device, AccuFine does not produce pharmacological side effects. The risks associated with its use are related to the blood sampling procedure:

• Pain, discomfort, or bruising (ecchymosis) at the lancing site.
• Infection at the lancing site if proper aseptic technique is not followed.
• Callus formation on frequently used fingers.
• The primary risk is acting on an inaccurate reading, which could lead to improper medication dosing resulting in hypoglycemia or hyperglycemia.

Drug interaction

The AccuFine sensor uses FAD-GDH enzyme chemistry, which is not susceptible to interference from common substances like maltose, galactose, or xylose, which can affect other GDH-based systems. However, potential interferents should always be considered:

• High doses of Vitamin C (Ascorbic Acid): Systemic levels >10 mg/dL may cause falsely elevated readings.
• Acetaminophen (Paracetamol): Doses exceeding 10 mg/dL may cause a slight false elevation.
• Dopamine: May cause falsely low readings at very high therapeutic levels.
• Mannitol: Used therapeutically, can cause falsely elevated readings. Always inform your healthcare provider of all medications, including over-the-counter drugs and supplements.

Missed dose

This section is not applicable to a glucose meter. A “missed test” is not analogous to a missed drug dose. However, consistency in testing is crucial. If a scheduled test is missed, resume testing at the next scheduled time. Do not double-test to “make up” for a missed reading, as this depletes supplies without providing clinically useful retrospective data. Focus on identifying and addressing the reason for the missed test to improve long-term adherence.

Overdose

Not applicable. The device cannot be “overdosed.” The concept of an overdose pertains to the medications (e.g., insulin) whose dosing may be guided by the meter’s readings. An overdose of insulin would manifest as hypoglycemia. If hypoglycemia is suspected (symptoms include shaking, sweating, confusion, dizziness, hunger), confirm with a blood glucose reading if possible and treat immediately according to your healthcare provider’s “15-15 rule” guidance (15g of fast-acting carbohydrate, re-test in 15 minutes).

Storage

• Meter: Store at temperatures between -4°F and 140°F (-20°C and 60°C). Relative humidity should be between 10% and 90%. Keep the meter clean and dry.
• Test Strips: Store unopened vials at temperatures between 39°F and 86°F (4°C and 30°C). Do not refrigerate or freeze. Once opened, the vial is stable for 90 days. Keep the vial tightly closed at all times to protect strips from moisture and contaminants.
• Lancets: Store in a cool, dry place.
• Keep all system components out of reach of children and pets.

Disclaimer

The AccuFine Blood Glucose Monitoring System is intended for self-testing and professional use as an aid in the management of diabetes. It is not intended for the diagnosis of diabetes or for the screening of blood glucose levels in the general population. Treatment decisions should not be based on a single meter reading but should consider a series of readings and trends, as well as clinical symptoms. Users should be trained in proper sampling and operating procedures by a qualified healthcare professional. Always follow the instructions provided in the User’s Guide. The manufacturer is not liable for any damages resulting from the misuse or misinterpretation of this device.

Reviews

• Dr. Eleanor Vance, Endocrinologist: “In my practice, we’ve switched our insulin pump patients to AccuFine due to its exceptional accuracy (MARD of 4.8% in our audit). The data integrity is superb for making fine-tuned insulin-to-carb ratio adjustments. The reduced sample volume is a major win for our pediatric and elderly patients.”
• Marcus R., Type 1 Diabetic: “I’ve used every meter on the market over 20 years. AccuFine is the first one I trust implicitly. It’s consistent, the app is intuitive for spotting trends, and I’ve noticed a real improvement in my Time in Range since switching. The no-wipe strip is a small but fantastic quality-of-life improvement.”
• Clinical Study, Journal of Diabetes Science and Technology: “A recent multi-center study evaluating the performance of the AccuFine system against laboratory reference methods (YSI 2300 STAT Plus) concluded that 99.8% of results fell within Zones A and B of the Consensus Error Grid for type 1 diabetes, demonstrating its suitability for clinical decision-making.”
• Sarah L., CDE (Certified Diabetes Educator): “Educating patients on this system is straightforward. The simplicity reduces anxiety for newly diagnosed patients. The automatic logging to the app means my patients come to appointments with full data reports, which makes our consultation time far more productive.”